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Change in number of shares and votes in BONESUPPORT HOLDING AB (publ)

29th December 2017

Change in number of shares and votes in BONESUPPORT HOLDING AB (publ)

Lund, Sweden, 18:00 CET 29 December 2017 - During December, the number of shares and votes in BONESUPPORT HOLDING AB (publ) has increased due to the exercise of warrants. As of
29 December 2017, the number of shares and votes in
BONESUPPORT HOLDING AB (publ) amounts to 50,277,890.

 

About BONESUPPORTTM

BONESUPPORT is an innovative and rapidly growing commercial stage orthobiologics company, based in Lund, Sweden. The Company develops and commercializes innovative injectable bio-ceramic bone graft substitutes that remodel to the patient’s own bone and have the capability of eluting drugs directly into the bone void. BONESUPPORT’s marketed bio-ceramic bone graft substitutes CERAMENT® BONE VOID FILLER (BVF), CERAMENT® G* and CERAMENT® V* are all based on the Company’s novel and proprietary CERAMENT technology platform.

The Company’s products are targeting a large addressable market opportunity across trauma, chronic osteomyelitis (bone infection), revision arthroplasty (replacement of a joint prosthesis) and infected diabetic foot.

BONESUPPORT’s total sales increased from SEK 41 million in 2014 to SEK 105 million in 2016, representing a compound annual growth rate of 60 percent. The Company’s financial target is to achieve revenue exceeding SEK 500 million in the financial year 2020, with a gross margin exceeding 85 percent and a positive operating profit.

The Company’s research and development is focused on the continuing development and refinement of its CERAMENT technology to extend its use into additional indications by the elution of other drugs and therapeutic agents. The Company currently has a pipeline of pre-clinical product candidates that have been designed to promote bone growth.

BONESUPPORT is listed on Nasdaq Stockholm and trades under the ticker “BONEX” (ISIN code: SE0009858152). Further information is available at bonesupport.com

*CERAMENT G: Not available in the United States, for investigational use only. CERAMENT V: Not available in the United States.

BONESUPPORT™ and CERAMENT® are registered trademarks.

For more information contact:

Richard Davies, CEO

Tel: +46 (0) 46 286 53 71

 

Björn Westberg, CFO

Tel: +46 (0) 46 286 53 60

Email: ir@bonesupport.com

The information in the press release is such that BONESUPPORT HOLDING AB (publ) is required to disclose pursuant to the Swedish Financial Instruments Trading Act. The information was submitted for publication, through the agency of the contact persons set out above, at 18:00 CET on 29 December 2017.

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Press release PDF (114.31 KB)

BONESUPPORT™ ACHIEVES AIM OF RECRUITING 136 PATIENTS INTO THE CERTiFy STUDY COMPARING CERAMENT®|BONE VOID FILLER WITH AUTOGRAFT

13th December 2017

BONESUPPORT™ ACHIEVES AIM OF RECRUITING 136 PATIENTS INTO THE CERTiFy STUDY COMPARING CERAMENT®|BONE VOID FILLER WITH AUTOGRAFT

Lund, Sweden, 08.00 CET, 13 December 2017 – BONESUPPORTTM, an emerging leader in innovative injectable bio-ceramic bone substitute products to treat bone voids caused by trauma, infection, disease or related surgery based on its unique CERAMENT® platform today announces that it has achieved its aim of recruiting 136 patients into the CERTiFy (CERAMENT® Treatment of Fracture defects) study.  

CERTiFy is a prospective, randomized, controlled clinical study designed to compare the differences in pain, quality of life, and cost of care in the treatment of tibia plateau fracture-associated bone defects using either CERAMENT®|BONE VOID FILLER (CERAMENT BVF) or autologous bone grafting (autograft). Autograft is the current gold standard for bone graft procedure for the management of tibia plateau fractures.

The primary outcome of the study is based on data from the SF-12 Physical Component Summary, which assesses the patient’s physical functioning, at week 26. The co-primary endpoint is the pain level 26 weeks after surgery measured by a visual analog scale. The SF-12 Mental Component Summary after 26 weeks and the costs of care will serve as key secondary endpoints.

Initial top-line data from the study is expected towards the end of 2018. A publication providing more complete data from the CERTiFy study is expected in Q1 2019.

The CERTiFy study recruited patients from 20 top orthopedic trauma centers in Germany. Professor Pol. M. Rommens, Head of The Department of Orthopaedics and Traumatology at The University Medical Centre Mainz is the study’s Principle Investigator.

Professor P.M. Rommens said: “Bone graft substitutes, such as CERAMENT BVF, are widely used for reconstruction of post-traumatic bone defects. However, their clinical significance in comparison to autograft, the gold-standard in reconstruction of larger bone defects, is still the subject to debate. With CERTiFy we aim to demonstrate that CERAMENT BVF is non-inferior to autograft across a range of clinical parameters. If achieved, this would be a major advance in the treatment of post-traumatic bone defects given the fact that not two but only one operative procedures are needed for filling up the defect.  I am looking forward to reporting the initial results from the study.”

BONESUPPORT CEO Richard Davies said: "We are pleased to have achieved this important milestone in the CERTiFy study that demonstrates BONESUPPORT’s ability to run significant complex multi-centre studies and generate Level I data that has the potential to change the practice of medicine. We are confident that positive data from CERTiFy would lead to much greater uptake of all CERAMENT products across multiple trauma indications due to their ease of use and lower procedure costs.”

 

About BONESUPPORT™

BONESUPPORT is an innovative and rapidly growing commercial stage orthobiologics company, based in Lund, Sweden. The Company develops and commercializes innovative injectable bio-ceramic bone graft substitutes that remodel to the patient’s own bone and have the capability of eluting drugs directly into the bone void.

BONESUPPORT’s marketed bio-ceramic bone graft substitutes CERAMENT® BONE VOID FILLER (BVF), CERAMENT® G* and CERAMENT® V* are all based on the Company’s novel and proprietary CERAMENT technology platform.

The Company’s products are targeting a large addressable market opportunity across trauma, chronic osteomyelitis (bone infection), revision arthroplasty (replacement of a joint prosthesis) and infected diabetic foot.

BONESUPPORT’s total sales increased from SEK 41 million in 2014 to SEK 105 million in 2016, representing a compound annual growth rate of 60 percent. The Company’s financial target is to achieve revenue exceeding SEK 500 million in the financial year 2020, with a gross margin exceeding 85 percent and a positive operating profit.

The Company’s research and development is focused on the continuing development and refinement of its CERAMENT technology to extend its use into additional indications by the elution of other drugs and therapeutic agents. The Company currently has a pipeline of pre-clinical product candidates that have been designed to promote bone growth.

BONESUPPORT is listed on Nasdaq Stockholm and trades under the ticker “BONEX” (ISIN code: SE0009858152). Further information is available at bonesupport.com

*CERAMENT G: Not available in the United States, for investigational use only.  CERAMENT V: Not available in the United States

BONESUPPORT™ and CERAMENT® are registered trademarks.

For more information contact:

Richard Davies, CEO

+46 (0) 46 286 53 71

 

Björn Westberg, CFO

+46 (0) 46 286 53 60

ir@bonesupport.com

 

Citigate Dewe Rogerson

Pip Batty, David Dible, Shabnam Bashir

+44 (0)20 7282 1022

bonesupport@citigatedewerogerson.com

This information is such information as BONESUPPORT HOLDING AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 08:00am CET on 13th December 2017.

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Press release PDF (473.81 KB)

BONESUPPORTTM OPENS ITS NEW HEAD QUARTERS

12th December 2017

BONESUPPORTTM OPENS ITS NEW HEAD QUARTERS

Lund, Sweden, 15.00 CET, 12th December 2017 – BONESUPPORTTM, an emerging leader in innovative injectable bio-ceramic bone substitute products to treat bone voids caused by trauma, infection, disease or related surgery based on its unique CERAMENT® platform, has opened new, enhanced facilities in Lund, as the Company continues to grow.

The new Lund-based offices offer brand new open-plan working space, laboratories with increased   R&D capabilities for the 27 staff working on site, with room for our global colleagues, meetings, workshops and trainings. The move comes at an important time for BONESUPPORT as the Company continues to invest in generating clinical evidence highlighting the benefits of its products, deepening its sales and marketing capabilities, while developing its pipeline and strengthening its senior management team.

Speaking at the official opening of the facility, Richard Davies, CEO of BONESUPPORT, said: “The Company’s move into new, larger offices reflects our significant growth ambitions. We believe that the commercial opportunity for CERAMENT® G, in the management of bone infections, combined with the longer-term potential of our pipeline position BONESUPPORT to become a leading orthobiologics company globally.  Our new offices will allow us to continue to recruit the talent we need to deliver our goals.”

 

About BONESUPPORT™

BONESUPPORT is an innovative and rapidly growing commercial stage orthobiologics company, based in Lund, Sweden. The Company develops and commercializes innovative injectable bio-ceramic bone graft substitutes that remodel to the patient’s own bone and have the capability of eluting drugs directly into the bone void.

BONESUPPORT’s marketed bio-ceramic bone graft substitutes CERAMENT® BONE VOID FILLER (BVF), CERAMENT® G* and CERAMENT® V* are all based on the Company’s novel and proprietary CERAMENT technology platform.

The Company’s products are targeting a large addressable market opportunity across trauma, chronic osteomyelitis (bone infection), revision arthroplasty (replacement of a joint prosthesis) and infected diabetic foot.

BONESUPPORT’s total sales increased from SEK 41 million in 2014 to SEK 105 million in 2016, representing a compound annual growth rate of 60 percent. The Company’s financial target is to achieve revenue exceeding SEK 500 million in the financial year 2020, with a gross margin exceeding 85 percent and a positive operating profit.

 

The Company’s research and development is focused on the continuing development and refinement of its CERAMENT technology to extend its use into additional indications by the elution of other drugs and therapeutic agents. The Company currently has a pipeline of pre-clinical product candidates that have been designed to promote bone growth.

BONESUPPORT is listed on Nasdaq Stockholm and trades under the ticker “BONEX” (ISIN code: SE0009858152). Further information is available at bonesupport.com

*CERAMENT G: Not available in the United States, for investigational use only. CERAMENT V: Not available in the United States

BONESUPPORT™ and CERAMENT® are registered trademarks.

For more information contact:

Richard Davies, CEO

+46 (0) 46 286 53 71

 

Björn Westberg, CFO

+46 (0) 46 286 53 60

ir@bonesupport.com

 

Citigate Dewe Rogerson

Pip Batty, David Dible, Shabnam Bashir

+44 (0)20 7282 1022

bonesupport@citigatedewerogerson.com

Downloads

Press release PDF (355.47 KB)

Change in number of shares and votes in BONESUPPORT HOLDING AB (publ)

30th November 2017

Change in number of shares and votes in BONESUPPORT HOLDING AB (publ)

Lund, Sweden, 18:00 CET 30 November 2017 - During November, the number of shares and votes in BONESUPPORT HOLDING AB (publ) has increased due to the exercise of warrants. As of
30 November 2017, the number of shares and votes in
BONESUPPORT HOLDING AB (publ) amounts to 50,000,821.

 

About BONESUPPORTTM

BONESUPPORT is an innovative and rapidly growing commercial stage orthobiologics company, based in Lund, Sweden. The Company develops and commercializes innovative injectable bio-ceramic bone graft substitutes that remodel to the patient’s own bone and have the capability of eluting drugs directly into the bone void. BONESUPPORT’s marketed bio-ceramic bone graft substitutes CERAMENT® BONE VOID FILLER (BVF), CERAMENT® G* and CERAMENT® V* are all based on the Company’s novel and proprietary CERAMENT technology platform.

The Company’s products are targeting a large addressable market opportunity across trauma, chronic
osteomyelitis (bone infection), revision arthroplasty (replacement of a joint prosthesis) and infected
diabetic foot.

BONESUPPORT’s total sales increased from SEK 41 million in 2014 to SEK 105 million in 2016, representing
a compound annual growth rate of 60 percent. The Company’s financial target is to achieve revenue
exceeding SEK 500 million in the financial year 2020, with a gross margin exceeding 85 percent and a
positive operating profit.

The Company’s research and development is focused on the continuing development and refinement of its CERAMENT technology to extend its use into additional indications by the elution of other drugs and therapeutic agents. The Company currently has a pipeline of pre-clinical product candidates that have been designed to promote bone growth.

BONESUPPORT is listed on Nasdaq Stockholm and trades under the ticker “BONEX” (ISIN code: SE0009858152). Further information is available at bonesupport.com

*CERAMENT G: Not available in the United States, for investigational use only. CERAMENT V: Not available in the United States.

BONESUPPORT™ and CERAMENT® are registered trademarks.

For more information contact:

Richard Davies, CEO

Tel: +46 (0) 46 286 53 71

 

Björn Westberg, CFO

Tel: +46 (0) 46 286 53 60

Email: ir@bonesupport.com

The information in the press release is such that BONESUPPORT HOLDING AB (publ) is required to disclose pursuant to the Swedish Financial Instruments Trading Act. The information was submitted for publication, through the agency of the contact persons set out above, at 18:00 CET on 30 November 2017.

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Press release PDF (114.67 KB)

BONESUPPORT HOLDING AB (publ) NOMINATION COMMITTEE FOR THE ANNUAL GENERAL MEETING 2018 APPOINTED

22nd November 2017

BONESUPPORT HOLDING AB (publ) NOMINATION COMMITTEE FOR THE ANNUAL GENERAL MEETING 2018 APPOINTED

Lund, Sweden, 18.30 CET, 22 November 2017 – BONESUPPORT HOLDING AB (publ), an emerging leader in innovative injectable bio-ceramic bone substitute products to treat bone voids caused by trauma, infection, disease or related surgery based on its unique CERAMENT® platform today announces that the Nomination Committee for the Annual General Meeting 2018 has been appointed.

According to the Swedish Corporate Governance Code, BONESUPPORT HOLDING AB (publ) shall have a Nomination Committee, the duties of which shall include the preparation and drafting of proposals regarding the election of members of the Board of Directors, the Chairman of the Board of Directors, the Chairman of the General Meeting and Auditors. The Nomination Committee shall also propose fees for Board members and the Auditor and principles for the appointment of the Nomination Committee. At the Annual General Meeting 2017, it was resolved to adopt an instruction for the Nomination Committee according to which the Nomination Committee shall consist of four members representing the three largest shareholders per 30 September 2017, together with the Chairman of the Board of Directors.

Based on the above, the Nomination Committee has been established to consist of:
-Håkan Björklund, Chairman of the Board of Directors
-Jacob Gunterberg, representing HealthCap V LP
-Johan Kördel, representing Lundbeckfonden Invest A/S
-Jonas Jendi, representing Stiftelsen Industrifonden
Jacob Gunterberg has been appointed Chairman of the Nomination Committee.

The Annual General Meeting will be held in Lund on Tuesday 22 May 2018.

Shareholders wishing to submit comments to the Nomination Committee may do so
-via email to    legal@bonesupport.com or
-by letter to     BONESUPPORT HOLDING AB,
                         Att: Nomination Committee,
                         Scheelevägen 19,
                         Ideon Science Park,
                         SE-223 70 Lund, Sweden.

To ensure that the proposals can be considered by the Nomination Committee, proposals shall be submitted in due time before the Annual General Meeting, but no later than 15 February 2018. The Nomination Committee’s proposals will be presented in the notice convening the Annual General Meeting and on the company’s website.

 

About BONESUPPORT™

BONESUPPORT is an innovative and rapidly growing commercial stage orthobiologics company, based in Lund, Sweden. The Company develops and commercializes innovative injectable bio-ceramic bone graft substitutes that remodel to the patient’s own bone and have the capability of eluting drugs directly into the bone void.

BONESUPPORT’s marketed bio-ceramic bone graft substitutes CERAMENT® BONE VOID FILLER (BVF), CERAMENT® G* and CERAMENT® V* are all based on the Company’s novel and proprietary CERAMENT technology platform.

The Company’s products are targeting a large addressable market opportunity across trauma, chronic osteomyelitis (bone infection), revision arthroplasty (replacement of a joint prosthesis) and infected diabetic foot.

BONESUPPORT’s total sales increased from SEK 41 million in 2014 to SEK 105 million in 2016, representing a compound annual growth rate of 60 percent. The Company’s financial target is to achieve revenue exceeding SEK 500 million in the financial year 2020, with a gross margin exceeding 85 percent and a positive operating profit.

The Company’s research and development is focused on the continuing development and refinement of its CERAMENT technology to extend its use into additional indications by the elution of other drugs and therapeutic agents. The Company currently has a pipeline of pre-clinical product candidates that have been designed to promote bone growth.

BONESUPPORT is listed on Nasdaq Stockholm and trades under the ticker “BONEX” (ISIN code: SE0009858152). Further information is available at bonesupport.com

*CERAMENT G: Not available in the United States, for investigational use only. CERAMENT V: Not available in the United States

BONESUPPORT™ and CERAMENT® are registered trademarks.

For more information contact:

Richard Davies, CEO

+46 (0) 46 286 53 71

 

Björn Westberg, CFO

+46 (0) 46 286 53 60

ir@bonesupport.com

 

Citigate Dewe Rogerson

Pip Batty, David Dible, Marine Perrier

+44 (0)20 7282 1022

bonesupport@citigatedewerogerson.com

 

The information was submitted for publication, through the agency of the contact persons set out above, at 18.30 CET on November 22, 2017.

Downloads

Press release PDF (124.49 KB)

BONESUPPORTTM SIGNS COMMERCIALIZATION AGREEMENT FOR THE ITALIAN MARKET

20th November 2017

BONESUPPORTTM SIGNS COMMERCIALIZATION AGREEMENT FOR THE ITALIAN MARKET

Lund, Sweden, 08.00 CET, 20 November 2017 – BONESUPPORTTM, an emerging leader in innovative injectable bio-ceramic bone substitute products to treat bone voids caused by trauma, infection, disease or related surgery based on its unique CERAMENT® platform today announces it has signed a second distribution agreement for Italy with Citieffe Srl to strengthen its access to trauma and orthopaedic surgeons in this market.

Citieffe is a trauma implant manufacturer based in Bologna. It is part of the Medistream Group, owned by ArchiMed an independent French Healthcare Investment Firm. Citieffe, which has a direct sales force in Italy with national coverage, views BONESUPPORT’s CERAMENT® products as a very synergistic addition to its current implant offering to trauma surgeons in particular.

This new commercialization agreement in Italy will improve coverage for BONESUPPORT’s products in a key European market. BONESUPPORT markets its products directly in five European countries: the UK, Germany, Switzerland, Sweden and Denmark. BONESUPPORT has a commercial team of 20 people in Europe focused on driving the sales of its antibiotic-eluting injectable bio-ceramic bone substitute products, CERAMENT® G and CERAMENT® V.

Richard Davies, CEO of BONESUPPORT, commented: “I am pleased that we have signed this agreement with Citieffe, a commercial partner that will give us access to a portfolio of new trauma customers in the Italian market. We see Italy as a particularly important sales opportunity for CERAMENT® G and CERAMENT® V given the size of the market and the clear clinical and economic benefits that our antibiotic-eluting products deliver.  I look forward to a mutually beneficial relationship with Citieffe.”

 

About BONESUPPORT™

BONESUPPORT is an innovative and rapidly growing commercial stage orthobiologics company, based in Lund, Sweden. The Company develops and commercializes innovative injectable bio-ceramic bone graft substitutes that remodel to the patient’s own bone and have the capability of eluting drugs directly into the bone void.

BONESUPPORT’s marketed bio-ceramic bone graft substitutes CERAMENT® BONE VOID FILLER (BVF), CERAMENT® G* and CERAMENT® V* are all based on the Company’s novel and proprietary CERAMENT technology platform.

The Company’s products are targeting a large addressable market opportunity across trauma, chronic osteomyelitis (bone infection), revision arthroplasty (replacement of a joint prosthesis) and infected diabetic foot.

BONESUPPORT’s total sales increased from SEK 41 million in 2014 to SEK 105 million in 2016, representing a compound annual growth rate of 60 percent. The Company’s financial target is to achieve revenue exceeding SEK 500 million in the financial year 2020, with a gross margin exceeding 85 percent and a positive operating profit.

The Company’s research and development is focused on the continuing development and refinement of its CERAMENT technology to extend its use into additional indications by the elution of other drugs and therapeutic agents. The Company currently has a pipeline of pre-clinical product candidates that have been designed to promote bone growth.

BONESUPPORT is listed on Nasdaq Stockholm and trades under the ticker “BONEX” (ISIN code: SE0009858152). Further information is available at bonesupport.com

*CERAMENT G: Not available in the United States, for investigational use only. CERAMENT V: Not available in the United States

BONESUPPORT™ and CERAMENT® are registered trademarks.

For more information contact:

Richard Davies, CEO

+46 (0) 46 286 53 71

 

Björn Westberg, CFO

+46 (0) 46 286 53 60

ir@bonesupport.com

 

Citigate Dewe Rogerson

Pip Batty, David Dible, Marine Perrier

+44 (0)20 7282 1022

bonesupport@citigatedewerogerson.com

Downloads

Press release PDF (122.29 KB)

BONESUPPORTTM - CERAMENT® G’s POTENTIAL TO PREVENT AND MANAGE BIOFILM-RELATED BONE INFECTIONS HIGHLIGHTED IN NEW HIGH-PROFILE PUBLICATION

14th November 2017

BONESUPPORTTM - CERAMENT® G’s POTENTIAL TO PREVENT AND MANAGE BIOFILM-RELATED BONE INFECTIONS HIGHLIGHTED IN NEW HIGH-PROFILE PUBLICATION

Lund, Sweden, 08.00 CET, 14 November 2017 – BONESUPPORTTM, an emerging leader in innovative injectable bio-ceramic bone substitute products to treat bone voids caused by trauma, infection, disease or related surgery based on its unique CERAMENT® platform announces the publication of a paper highlighting the anti-biofilm activity of CERAMENT® G in vitro - Colloids and Surfaces B: Biointerfaces 161 (2018) 252–260.

Implant-related bone infections caused by microorganisms that grow in biofilms are extremely difficult to treat and cause persistent and recurring infections. The use of resorbable biomaterials, such as CERAMENT®, as a reservoir for the local release of antimicrobials, such as gentamicin, into the bone and onto the implant is considered as a valid option to achieve high local concentrations of the drug and, therefore, avoid infection relapses and microbial resistance.

In the study reported in the publication ”In vitro anti-biofilm activity of a biphasic gentamicin-loaded calcium sulfate/hydroxyapatite bone graft substitute” by Maria Eugenia Butini and Mariagrazia Di Luca from the group of Andrej Trampuz from the Center for Musculoskeletal Surgery, Charité – Universitätsmedizin Berlin, CERAMENT® G beads were assessed for their in vitro antimicrobial activity against bacteria known to cause bone infections, including planktonic and biofilm S. agalactiae, S. aureus, S. epidermidis, E. faecalis and E. coli, using standard methods and ultra-sensitive isothermal microcalorimetry.

The authors found that CERAMENT® G possesses a preventive and bactericidal anti-biofilm activity in vitro against some selected bacterial strains that are responsible for bone infections.  The authors also believe that high concentrations of gentamicin achieved through the initial burst release from CERAMENT® G within the first 3 hours of its use, together with the retention of a sustained level of antibiotic for at least 24 hours, could effectively suppress an early infection in the first stages of bacterial replication. They concluded, that their in vitro study “demonstrated the potential of the gentamicin-loaded bone graft substitute to prevent and treat biofilm-related bone and implant infections”.

Dr. Andrej Trampuz from Center for Musculoskeletal Surgery, Charité – Universitätsmedizin Berlin, commenting on his research group’s findings, said, “We are excited with the in vitro data that we have generated on CERAMENT® G. It clearly shows that CERAMENT® G provides a good solution for orthopaedic surgeons to prevent and manage biofilm-related bone infections. I look forward to seeing this potential being confirmed in clinical practice.”

Richard Davies, CEO of BONESUPPORT, commented: “This publication demonstrating the in vitro activity of CERAMENT® G against multiple bacteria known to cause bone infections and that grow in biofilms, highlights another important potential clinical benefit of this unique injectable bio-ceramic bone substitute.  Our investment in supportive clinical and pre-clinical data is key to the continuing rapid adoption of CERAMENT® G by the orthopedic community.”

 

About BONESUPPORT

BONESUPPORT is an innovative and rapidly growing commercial stage orthobiologics company, based in Lund, Sweden. The Company develops and commercializes innovative injectable bio-ceramic bone graft substitutes that remodel to the patient’s own bone and have the capability of eluting drugs directly into the bone void.

 

BONESUPPORT’s marketed bio-ceramic bone graft substitutes CERAMENT® BONE VOID FILLER (BVF), CERAMENT® G* and CERAMENT® V* are all based on the Company’s novel and proprietary CERAMENT technology platform.

The Company’s products are targeting a large addressable market opportunity across trauma, chronic osteomyelitis (bone infection), revision arthroplasty (replacement of a joint prosthesis) and infected diabetic foot.

BONESUPPORT’s total sales increased from SEK 41 million in 2014 to SEK 105 million in 2016, representing a compound annual growth rate of 60 percent. The Company’s financial target is to achieve revenue exceeding SEK 500 million in the financial year 2020, with a gross margin exceeding 85 percent and a positive operating profit.

The Company’s research and development is focused on the continuing development and refinement of its CERAMENT technology to extend its use into additional indications by the elution of other drugs and therapeutic agents. The Company currently has a pipeline of pre-clinical product candidates that have been designed to promote bone growth.

BONESUPPORT is listed on Nasdaq Stockholm and trades under the ticker “BONEX” (ISIN code: SE0009858152). Further information is available at bonesupport.com

*CERAMENT G: Not available in the United States, for investigational use only. CERAMENT V: Not available in the United States

BONESUPPORT and CERAMENT® are registered trademarks.

For more information contact:

Richard Davies, CEO

+46 (0) 46 286 53 71

 

Björn Westberg, CFO

+46 (0) 46 286 53 60

ir@bonesupport.com

 

Citigate Dewe Rogerson

Pip Batty, David Dible, Marine Perrier

+44 (0)20 7282 1022

bonesupport@citigatedewerogerson.com

Downloads

Press release PDF (445.29 KB)

BONESUPPORT HOLDING AB (publ) – Interim Report – January – September 2017

2nd November 2017

BONESUPPORT HOLDING AB (publ) – Interim Report – January – September 2017

Lund, Sweden, 08.00 CET, 2 November 2017 – BONESUPPORTTM, an emerging leader in innovative injectable bio-ceramic bone substitute products to treat bone voids caused by trauma, infection, disease or related surgery based on its unique CERAMENT® platform today announces the publication of its Interim Report January – September 2017.

Q3 Net sales increased by 23%

FINANCIAL HIGHLIGHTS

JULY – SEPTEMBER 2017

Net Sales amounted to SEK 32.7 million (26.5), an increase of 23%

Gross margin of 87.8% (79.2)

Operating loss of SEK -20.1 million (-25.9)

Earnings per share, before and after dilution was SEK -0.47 (-1.39)

 

JANUARY – SEPTEMBER 2017

Net Sales amounted to SEK 102.3 million (75.0), an increase of 36%

Gross margin of 87.9% (83.1)

Operating loss of SEK -65.9 million (-60.3)

Earnings per share, before and after dilution was SEK -2.13 (-3.01)

 

BUSINESS HIGHLIGHTS 

JULY – SEPTEMBER 2017

The over-allotment option, in relation to the IPO, allowed the Company to raise further SEK 59 million. The total issue including the over-allotment option, in conjunction with the IPO, was 19,285,345 shares raising a total of SEK 559 million before SEK 38.7 million in transaction costs.

BONESUPPORT announced 13 July a pipeline project targeting Bioceramics to enhance bone growth was awarded SEK 8 million grant from Vinnova.

BONESUPPORT announced 7 September an agreement with Novomedics to commercialize CERAMENT® G in the French market.

BONESUPPORT announced 19 September the appointment of Dr Jerry Chang as Executive VP R&D.

 

SIGNIFICANT EVENTS AFTER PERIOD END

BONESUPPORT announced 9 October the first patient recruited into the Revision Arthroplasty study in Italy.

BONESUPPORT announced 13 October the appointment of Helena L Brandt as Head of Human Resources.

 

Richard Davies, CEO of BONESUPPORT, said: “BONESUPPORT has made good progress in the third quarter.  We have seen a solid increase in sales driven by the continuing success of our antibiotic eluting products, CERAMENT G and CERAMENT V, which together saw a 48% increase in revenues. We have also presented new compelling clinical data at major European orthopedic conferences, which demonstrate the clear benefits these products deliver. In October, we recruited the first patient evaluating CERAMENT G and V in patients undergoing revision arthroplasty. A successful study outcome would open-up a major commercial opportunity for BONESUPPORT. We also strengthened our management team with appointment of Dr Jerry Chang who will help us to generate value from our pipeline of novel CERAMENT products which are designed to enhance bone growth.”

 

The full Q3 Report is available by clicking on the links below:

Outside the US: https://bonesupport.com/en-eu/financial-reports-inv/

US: https://bonesupport.com/en-us/financial-reports-us/

 

The report will be available on BONESUPPORT’s website from 08:00 am CET the same day and the presentation from the webcast will be uploaded during the day on 2 November.

 

Conference Call

The Company will host a conference call and an online presentation at 10.00am CET today.

The dial-in numbers for the conference call are:

UK: +44 20 30089806

SE: +46 85 0639 549

US: +1 855 8315945 UK: +442030089806SE: +46850639549US: +18558315945

The dial-in numbers for the conference call are:

UK: +442030089806

SE: +46850639549

US: +18558315945

The presentation will also be webcast and can be accessed from the following web address:

http://www.financialhearings.com/event/10531

The dial-in numbers for the conference call are:

UK: +442030089806

SE: +46850639549

US: +18558315945

The presentation will also be webcast and can be accessed from the following web address:

http://www.financialhearings.com/event/10531

The dial-in numbers for the conference call are:

UK: +442030089806

SE: +46850639549

US: +18558315945

The presentation will also be webcast and can be accessed from the following web address:

http://www.financialhearings.com/event/10531

Webcast

The presentation will also be webcast and can be accessed from the following web address: http://www.financialhearings.com/event/10531  

 

Hosts: Richard Davies, CEO, and Björn Westberg, CFO

 

About BONESUPPORT™

BONESUPPORT is an innovative and rapidly growing commercial stage orthobiologics company, based in Lund, Sweden. The Company develops and commercializes innovative injectable bio-ceramic bone graft substitutes that remodel to the patient’s own bone and have the capability of eluting drugs directly into the bone void.

BONESUPPORT’s marketed bio-ceramic bone graft substitutes CERAMENT® BONE VOID FILLER (BVF), CERAMENT® G* and CERAMENT® V* are all based on the Company’s novel and proprietary CERAMENT technology platform.

The Company’s products are targeting a large addressable market opportunity across trauma, chronic osteomyelitis (bone infection), revision arthroplasty (replacement of a joint prosthesis) and infected diabetic foot.

BONESUPPORT’s total sales increased from SEK 41 million in 2014 to SEK 105 million in 2016, representing a compound annual growth rate of 60 percent. The Company’s financial target is to achieve revenue exceeding SEK 500 million in the financial year 2020, with a gross margin exceeding 85 percent and a positive operating profit.

The Company’s research and development is focused on the continuing development and refinement of its CERAMENT technology to extend its use into additional indications by the elution of other drugs and therapeutic agents. The Company currently has a pipeline of pre-clinical product candidates that have been designed to promote bone growth.

BONESUPPORT is listed on Nasdaq Stockholm and trades under the ticker “BONEX” (ISIN code: SE0009858152). Further information is available at bonesupport.com

*CERAMENT G: Not available in the United States, for investigational use only. CERAMENT V: Not available in the United States

BONESUPPORT™ and CERAMENT® are registered trademarks.

For more information contact:

Richard Davies, CEO

+46 (0) 46 286 53 71

 

Björn Westberg, CFO

+46 (0) 46 286 53 60

ir@bonesupport.com

 

Citigate Dewe Rogerson

Pip Batty, David Dible, Marine Perrier

+44 (0)20 7282 1022

bonesupport@citigatedewerogerson.com

Downloads

Press release PDF (449.54 KB)

Change in number of shares and votes in BONESUPPORT HOLDING AB (publ)

31st October 2017

Change in number of shares and votes in BONESUPPORT HOLDING AB (publ)

Lund, Sweden, 18:00 CET 31st October 2017 - During October, the number of shares and votes in BONESUPPORT HOLDING AB (publ) has increased due to the exercise of warrants. As of 31st October 2017, the number of shares and votes in BONESUPPORT HOLDING AB (publ) amounts to 49,900,591.

 

About BONESUPPORTTM

BONESUPPORT is an innovative and rapidly growing commercial stage orthobiologics company, based in Lund, Sweden. The Company develops and commercializes innovative injectable bio-ceramic bone graft substitutes that remodel to the patient’s own bone and have the capability of eluting drugs directly into the bone void. BONESUPPORT’s marketed bio-ceramic bone graft substitutes CERAMENT® BONE VOID FILLER (BVF), CERAMENT® G* and CERAMENT® V* are all based on the Company’s novel and proprietary CERAMENT technology platform.

The Company’s products are targeting a large addressable market opportunity across trauma, chronic osteomyelitis (bone infection), revision arthroplasty (replacement of a joint prosthesis) and infected diabetic foot.

BONESUPPORT’s total sales increased from SEK 41 million in 2014 to SEK 105 million in 2016, representing a compound annual growth rate of 60 percent. The Company’s financial target is to achieve revenue exceeding SEK 500 million in the financial year 2020, with a gross margin exceeding 85 percent and a positive operating profit.

The Company’s research and development is focused on the continuing development and refinement of its CERAMENT technology to extend its use into additional indications by the elution of other drugs and therapeutic agents. The Company currently has a pipeline of pre-clinical product candidates that have been designed to promote bone growth.

BONESUPPORT is listed on Nasdaq Stockholm and trades under the ticker “BONEX” (ISIN code: SE0009858152). Further information is available at bonesupport.com

*CERAMENT G: Not available in the United States, for investigational use only. CERAMENT V: Not available in the United States.

BONESUPPORT™ and CERAMENT® are registered trademarks.

For more information contact:

Richard Davies, CEO

Tel: +46 (0) 46 286 53 71

 

Björn Westberg, CFO

Tel: +46 (0) 46 286 53 60

Email: ir@bonesupport.com

The information in the press release is such that BONESUPPORT HOLDING AB (publ) is required to disclose pursuant to the Swedish Financial Instruments Trading Act. The information was submitted for publication, through the agency of the contact persons set out above, at 18:00 CET on 31st October 2017.

Downloads

Press release PDF (433.37 KB)

BONESUPPORT HOLDING AB (publ) – Q3 2017 Interim Report – invitation to conference call and webcast

19th October 2017

BONESUPPORT HOLDING AB (publ) – Q3 2017 Interim Report – invitation to conference call and webcast

Lund, Sweden, 08:00 CEST 19 October 2017 – BONESUPPORT™ an emerging leader in innovative injectable bio-ceramic bone substitute products to treat bone voids caused by trauma, infection, disease or related surgery based on its unique CERAMENT® platform, will publish its Q3 2017 Interim Report on Thursday 2 November 2017 at 08.00am CEST.

The Company will also host a conference call and an online presentation on the same day at 10am CEST.

 

The dial-in numbers for the conference call are:

UK: +442030089806

SE: +46850639549

US: +18558315945

The presentation will also be webcast and can be accessed from the following web address:

http://www.financialhearings.com/event/10531

Hosts: Richard Davies, CEO, and Björn Westberg, CFO

 

Notes to Editor

About BONESUPPORTTM

BONESUPPORT is an innovative and rapidly growing commercial stage orthobiologics company, based in Lund, Sweden. The Company develops and commercializes innovative injectable bio-ceramic bone graft substitutes that remodel to the patient’s own bone and have the capability of eluting drugs directly into the bone void. BONESUPPORT’s marketed bio-ceramic bone graft substitutes CERAMENT® BONE VOID FILLER (BVF), CERAMENT® G* and CERAMENT® V* are all based on the Company’s novel and proprietary CERAMENT technology platform.

The Company’s products are targeting a large addressable market opportunity across trauma, chronic
osteomyelitis (bone infection), revision arthroplasty (replacement of a joint prosthesis) and infected
diabetic foot.

BONESUPPORT’s total sales increased from SEK 41 million in 2014 to SEK 105 million in 2016, representing a compound annual growth rate of 60 percent. The Company’s financial target is to achieve revenue exceeding SEK 500 million in the financial year 2020, with a gross margin exceeding 85 percent and a positive operating profit.

The Company’s research and development is focused on the continuing development and refinement of its CERAMENT technology to extend its use into additional indications by the elution of other drugs and therapeutic agents. The Company currently has a pipeline of pre-clinical product candidates that have been designed to promote bone growth.

BONESUPPORT is listed on Nasdaq Stockholm and trades under the ticker “BONEX” (ISIN code: SE0009858152). Further information is available at bonesupport.com

*CERAMENT G: Not available in the United States, for investigational use only. CERAMENT V: Not available in the United States.

BONESUPPORT™ and CERAMENT® are registered trademarks.

 

Contact Information

BONESUPPORT AB

Richard Davies, CEO

Tel: +46 (0) 46 286 53 71

 

Björn Westberg, CFO

Tel: +46 (0) 46 286 53 60

Email: ir@bonesupport.com

 

Citigate Dewe Rogerson

David Dible, Pip Batty, Marine Perrier

+44 (0)20 7638 9571

bonesupport@citigatedr.co.uk

Downloads

Press release PDF (306.92 KB)

BONESUPPORTTM APPOINTS HELENA L BRANDT AS HEAD OF HUMAN RESOURCES

13th October 2017

BONESUPPORTTM APPOINTS HELENA L BRANDT AS HEAD OF HUMAN RESOURCES

Lund, Sweden, 12.00 CEST, 13 October 2017 – BONESUPPORTTM, an emerging leader in innovative injectable bio-ceramic bone substitute products to treat bone voids caused by trauma, infection, disease or related surgery based on its unique CERAMENT® platform announces the appointment of Helena L Brandt as its new Head of Human Resources. Her appointment is to meet the demands of a fast moving market and the growing professional global leadership team. Reporting directly to CEO Richard Davies Helena will join the Executive Leadership Team. 

Helena L Brandt has more than 20 years of HR and leadership experience working with organizations operating within the field of Research & Development. Her career includes positions at large global companies such as TetraPak, Sony Ericsson and AstraZeneca and with smaller fast growing companies. Helena held several, mainly global, HR business partner positions at Director and VP-level focusing on company leadership, internal communications, culture and competence development. Helena will join BONESUPPORT on 16 October.

 

About BONESUPPORT™

BONESUPPORT is an innovative and rapidly growing commercial stage orthobiologics company, based in Lund, Sweden. The Company develops and commercializes innovative injectable bio-ceramic bone graft substitutes that remodel to the patient’s own bone and have the capability of eluting drugs directly into the bone void.

BONESUPPORT’s marketed bio-ceramic bone graft substitutes CERAMENT® BONE VOID FILLER (BVF), CERAMENT® G* and CERAMENT® V* are all based on the Company’s novel and proprietary CERAMENT technology platform.

The Company’s products are targeting a large addressable market opportunity across trauma, chronic osteomyelitis (bone infection), revision arthroplasty (replacement of a joint prosthesis) and infected diabetic foot.

BONESUPPORT’s total sales increased from SEK 41 million in 2014 to SEK 105 million in 2016, representing a compound annual growth rate of 60 percent. The Company’s financial target is to achieve revenue exceeding SEK 500 million in the financial year 2020, with a gross margin exceeding 85 percent and a positive operating profit.

The Company’s research and development is focused on the continuing development and refinement of its CERAMENT technology to extend its use into additional indications by the elution of other drugs and therapeutic agents. The Company currently has a pipeline of pre-clinical product candidates that have been designed to promote bone growth.

 

BONESUPPORT is listed on Nasdaq Stockholm and trades under the ticker “BONEX” (ISIN code: SE0009858152). Further information is available at bonesupport.com

*CERAMENT G: Not available in the United States, for investigational use only. CERAMENT V: Not available in the United States

BONESUPPORT™ and CERAMENT® are registered trademarks.

For more information contact:

Richard Davies, CEO

+46 (0) 46 286 53 71

 

Björn Westberg, CFO

+46 (0) 46 286 53 60

ir@bonesupport.com

 

Citigate Dewe Rogerson

Pip Batty, David Dible, Marine Perrier

+44 (0)20 7282 1022

bonesupport@citigatedr.co.uk

Downloads

Press release PDF (355.91 KB)

BONESUPPORTTM – First Patient Recruited in Study Evaluating CERAMENT® G and CERAMENT® V in Patients Undergoing Hip and Knee Arthroplasty Revisions

9th October 2017

BONESUPPORTTM – First Patient Recruited in Study Evaluating CERAMENT® G and CERAMENT® V in Patients Undergoing Hip and Knee Arthroplasty Revisions

Lund, Sweden, 08:00 CEST 9 October 2017 – BONESUPPORTTM an emerging leader in innovative injectable bio-ceramic bone substitute products to treat bone voids caused by trauma, infection, disease or related surgery based on its unique CERAMENT® platformannounces that the first patient has been recruited in a study evaluating CERAMENT® G and CERAMENT® V in patients undergoing hip and knee arthroplasty revisions. Professor Carlo Romanò is the Principal Investigator for the study, which will take place at 6 different clinical centers in Italy and is expected to recruit approximately 135 patients.

The investigator-led study is an open-label, prospective cohort, observational clinical trial designed to evaluate the effectiveness and safety of CERAMENT G or CERAMENT V when used to fill bone defects in the tibia and/or femur shaft and/or acetabulum in patients scheduled for two-stage hip or knee prosthesis re-implantation for periprosthetic joint infections (PJIs).

The results from the study will be compared to a cohort of patients, at the same clinical centers, who were treated using current standard, of care.

The aim of the study is to show an improved clinical outcome and a lower infection rate for the CERAMENT G or CERAMENT V group compared to the retrospective control cohort where neither CERAMENT G or CERAMENT V were used.

One endpoint of the study will be the rate of PJIs according to the Musculoskeletal Infection Society (MSIS) criteria during the one year follow-up.

Professor Carlo Romanò, the study’s Principal Investigator, said: "PJIs remain one of the most feared complications after orthopedic surgery. The ability of microorganisms to adhere to the surface of an implant and to immediately produce a protective biofilm is currently considered as the main challenge in the treatment of implant-related infections. At present, there is no accepted approach for preventing recurring PJIs in patients undergoing revision arthroplasty. We have already conducted a pilot study that showed a beneficial outcome from using CERAMENT G and CERAMENT V in a small series of patients undergoing two-stage knee and hip arthroplasty revisions. The aim of the larger study which we are now conducting is to confirm these promising initial results in a larger cohort of patients and compare the results to a retrospective control.”

Richard Davies, CEO of BONESUPPORT, commented: “The start of this study is a key step in our strategy to build a compelling data set to support the prophylactic use of both CERAMENT G and CERAMENT V in patients undergoing hip and knee arthroplasty revisions. We are confident that CERAMENT G and CERAMENT V’s ability to elute the antibiotics gentamicin and vancomycin respectively, while at the same time, remodeling to bone, will allow them to deliver a reduction in the rate of PJIs in this study.” 

 

About BONESUPPORTTM

BONESUPPORT is an innovative and rapidly growing commercial stage orthobiologics company, based in Lund, Sweden. The Company develops and commercializes innovative injectable bio-ceramic bone graft substitutes that remodel to the patient’s own bone and have the capability of eluting drugs directly into the bone void. BONESUPPORT’s marketed bio-ceramic bone graft substitutes CERAMENT® BONE VOID FILLER (BVF), CERAMENT® G and CERAMENT® V are all based on the Company’s novel and proprietary CERAMENT technology platform.

The Company’s products are targeting a large addressable market opportunity across trauma, chronic
osteomyelitis (bone infection), revision arthroplasty (replacement of a joint prosthesis) and infected
diabetic foot.

BONESUPPORT’s total sales increased from SEK 41 million in 2014 to SEK 105 million in 2016, representing a compound annual growth rate of 60 percent. The Company’s financial target is to achieve revenue exceeding SEK 500 million in the financial year 2020, with a gross margin exceeding 85 percent and a positive
operating profit.

The Company’s research and development is focused on the continuing development and refinement of its CERAMENT technology to extend its use into additional indications by the elution of other drugs and therapeutic agents. The Company currently has a pipeline of pre-clinical product candidates that have been designed to promote bone growth.

BONESUPPORT is listed on Nasdaq Stockholm and trades under the ticker “BONEX” (ISIN code: SE0009858152). Further information is available at bonesupport.com

*CERAMENT G: Not available in the United States, for investigational use only. CERAMENT V: Not available in the United States.

BONESUPPORT™ and CERAMENT® are registered trademarks.

For more information contact:

Richard Davies, CEO

Tel: +46 (0) 46 286 53 71

Björn Westberg, CFO

Tel: +46 (0) 46 286 53 60

Email: ir@bonesupport.com

Citigate Dewe Rogerson

David Dible, Mark Swallow, Marine Perrier

+44 (0)20 7638 9571

bonesupport@citigatedr.co.uk

Downloads

Press release PDF (293.47 KB)

Change in number of shares and votes in BONESUPPORT HOLDING AB (publ)

29th September 2017

Change in number of shares and votes in BONESUPPORT HOLDING AB (publ)

Lund, Sweden, 18:00 CEST 29th September 2017 - During September, the number of shares and votes in BONESUPPORT HOLDING AB (publ) has increased due to the exercise of warrants. As of 29th September, 2017, the number of shares and votes in BONESUPPORT HOLDING AB (publ) amounts to 49,650,651.

 

About BONESUPPORTTM

BONESUPPORT is an innovative and rapidly growing commercial stage orthobiologics company, based in Lund, Sweden. The Company develops and commercializes innovative injectable bio-ceramic bone graft substitutes that remodel to the patient’s own bone and have the capability of eluting drugs directly into the bone void. BONESUPPORT’s marketed bio-ceramic bone graft substitutes CERAMENT® BONE VOID FILLER (BVF), CERAMENT® G* and CERAMENT® V* are all based on the Company’s novel and proprietary CERAMENT technology platform.

The Company’s products are targeting a large addressable market opportunity across trauma, chronic 
osteomyelitis (bone infection), revision arthroplasty (replacement of a joint prosthesis) and infected 
diabetic foot.

BONESUPPORT’s total sales increased from SEK 41 million in 2014 to SEK 105 million in 2016, representing a compound annual growth rate of 60 percent. The Company’s financial target is to achieve revenue exceeding SEK 500 million in the financial year 2020, with a gross margin exceeding 85 percent and a positive
operating profit.

The Company’s research and development is focused on the continuing development and refinement of its CERAMENT technology to extend its use into additional indications by the elution of other drugs and therapeutic agents. The Company currently has a pipeline of pre-clinical product candidates that have been designed to promote bone growth.

BONESUPPORT is listed on Nasdaq Stockholm and trades under the ticker “BONEX” (ISIN code: SE0009858152). Further information is available at bonesupport.com

*CERAMENT G: Not available in the United States, for investigational use only. CERAMENT V: Not available in the United States.

BONESUPPORT™ and CERAMENT® are registered trademarks.

For more information contact:

Richard Davies, CEO

Tel: +46 (0) 46 286 53 71

 

Björn Westberg, CFO

Tel: +46 (0) 46 286 53 60

Email: ir@bonesupport.com

The information in the press release is such that BONESUPPORT HOLDING AB (publ) is required to disclose pursuant to the Swedish Financial Instruments Trading Act. The information was submitted for publication, through the agency of the contact persons set out above, at 18:00 CET on September 29, 2017.

Downloads

Press release PDF (370.96 KB)

BONESUPPORT™ – DATA PRESENTED AT THE EUROPEAN ORTHOPAEDIC RESEARCH SOCIETY MEETING HIGHLIGHTS CERAMENT® BONE VOID FILLER (BVF) ABILITY TO ELUTE DRUGS WITH THE POTENTIAL TO ENHANCE BONE GROWTH

20th September 2017

BONESUPPORT™ – DATA PRESENTED AT THE EUROPEAN ORTHOPAEDIC RESEARCH SOCIETY MEETING HIGHLIGHTS CERAMENT® BONE VOID FILLER (BVF) ABILITY TO ELUTE DRUGS WITH THE POTENTIAL TO ENHANCE BONE GROWTH

Lund, Sweden, 08.00 CEST, 20  September 2017 – BONESUPPORT an emerging leader in innovative injectable bio-ceramic bone substitute products to treat bone voids caused by trauma, infection, disease or related surgery based on its unique CERAMENT platform  announces that a pre-clinical  study evaluating the in-vivo release kinetics of radio-labelled bone morphogenic protein (rhBMP-2) and zoledronic acid (ZA) from CERAMENT BVF was presented at the European Orthopaedic Research Society (EORS) in Munich on 15th  September. The presentation was given by Mr Deepak Raina, Department of Orthopaedics, Medical Faculty, Lund University, Sweden.

In his presentation, Mr Raina, outlined data showing that CERAMENT BVF achieved co-delivery of both rhBMP-2 and ZA in-vivo measured over a period of four weeks. After 4 weeks, CERAMENT BVF had eluted 57% of rhBMP-2 and 23% of ZA. This is an important finding since the constant availability of rhBMP-2 over a long period could give osteo-inductive properties to CERAMENT BVF while at the same time the presence of ZA locally prevents bone resorption.  

These data suggest that by using CERAMENT BVF to elute BMPs it could be possible to overcome the problems of local delivery of BMPs using currently available approaches.

Another pre-clinical study, which demonstrated in vivo that CERAMENT loaded with a combination of rhBMP-2 and ZA in very low doses was able to quantitatively and qualitatively generate a high amount of mineralized bone volume was covered in a paper published in Nature Scientific Reports (Raina, D et al, reference below). The study showed that the mineralized volume was significantly higher when CERAMENT was combined with rhBMP-2 and ZA compared to CERAMENT in combination with just rhBMP-2.

Mr Deepak Raina, commenting on his presentation said: “The important findings that we presented at EORS suggest that by capitalizing on CERAMENT BVF’s elution characteristics it could be possible to overcome the current problems associated with the local delivery of BMP to promote bone growth. The growing body of data that our research group is generating with CERAMENT BVF provides greater confidence that this novel approach could lead to a commercially available product able to enhance bone growth.” 

Richard Davies, CEO of BONESUPPORT, commented: “We are pleased that these in vivo data on CERAMENT BVF combined with bone morphogenic protein and zoledronic acid have been presented at this prestigious scientific conference. These data provide further support to our product pipeline strategy which is focused on developing new CERAMENT products that are able to enhance bone growth.”

Raina, D. et al. A Biphasic Calcium Sulfate Hydroxapatite Carrier Bone Morphogenic Protein -2 and Zoledronic Acid Generates Bone (2016) Nature Scientific Reports  http://bit.ly/22xgU84

 

About BONESUPPORT™

BONESUPPORT is an innovative and rapidly growing commercial stage orthobiologics company, based in Lund, Sweden. The Company develops and commercializes innovative injectable bio-ceramic bone graft substitutes that remodel to the patient’s own bone and have the capability of eluting drugs directly into the bone void.

BONESUPPORT’s marketed bio-ceramic bone graft substitutes CERAMENT®BONE VOID FILLER (BVF), CERAMENT® G* and CERAMENT® V* are all based on the Company’s novel and proprietary CERAMENT technology platform.

The Company’s products are targeting a large addressable market opportunity across trauma, chronic osteomyelitis (bone infection), revision arthroplasty (replacement of a joint prosthesis) and infected diabetic foot.

BONESUPPORT’s total sales increased from SEK 41 million in 2014 to SEK 105 million in 2016, representing a compound annual growth rate of 60 percent. The Company’s financial target is to achieve revenue exceeding SEK 500 million in the financial year 2020, with a gross margin exceeding 85 percent and a positive operating profit.

The Company’s research and development is focused on the continuing development and refinement of its CERAMENT technology to extend its use into additional indications by the elution of other drugs and therapeutic agents. The Company currently has a pipeline of pre-clinical product candidates that have been designed to promote bone growth.

BONESUPPORT is listed on Nasdaq Stockholm and trades under the ticker “BONEX” (ISIN code: SE0009858152). Further information is available at bonesupport.com

*CERAMENT G: Not available in the United States, for investigational use only. CERAMENT V: Not available in the United States

BONESUPPORT™ and CERAMENT® are registered trademarks.

For more information contact:

Richard Davies, CEO

Tel: +46 (0) 46 286 53 71

 

Björn Westberg, CFO

Tel: +46 (0) 46 286 53 60

Email: ir@bonesupport.com

 

Citigate Dewe Rogerson

Pip Batty, David Dible, Marine Perrier

+44 (0)20 7282 1022

bonesupport@citigatedr.co.uk

Downloads

Press release PDF (477.7 KB)

BONESUPPORT APPOINTS JERRY CHANG AS EXECUTIVE VICE PRESIDENT OF RESEARCH & DEVELOPMENT

19th September 2017

BONESUPPORT APPOINTS JERRY CHANG AS EXECUTIVE VICE PRESIDENT OF RESEARCH & DEVELOPMENT

Lund, Sweden, 12.00 CEST, 19 September 2017 – BONESUPPORTTM, an emerging leader in innovative injectable bio-ceramic bone substitute products to treat bone voids caused by trauma, infection, disease or related surgery based on its unique CERAMENT® platform today announces that it has appointed Dr. Jerry Chang as its Executive Vice President of Research & Development.

Dr Chang has more than 28 years of experience in the research, development and commercialization of medical devices in the orthopedic, regenerative medicine and biomaterials space. He joins BONESUPPORT from Zimmer Biomet Etex, a subsidiary of Zimmer Biomet that develops and commercializes products that address bone repair and regeneration. Etex was acquired by Zimmer Biomet in 2014. Dr Chang has worked for Etex and Zimmer Biomet Etex, as Vice President of Research & Development for over decade.

During that period, Dr Chang has been involved in the development and launch of several bone and fracture healing products, including hardware solutions and curable calcium phosphate. He has also led the development of a number of combination products that contained biologics or cells to promote bone growth.

Prior to Zimmer Biomet Etex, Dr Chang worked at Johnson & Johnson and Bristol-Myers Squibb ConvaTec.

Dr Chang has published over 20 papers and has five issued US patents.

Richard Davies, CEO of BONESUPPORT, commented: “We are delighted to welcome Dr. Chang to the team. We are confident his extensive experience in the creation and development of novel products and their launch worldwide will contribute greatly as we seek to expand our range of products on a global scale.”

Dr. Jerry Chang, commenting on his appointment said: “I am very pleased to be joining BONESUPPORT to lead its R&D activities at this very exciting time for the Company. I have been extremely impressed with the CERAMENT platform given its proven ability to remodel to host bone and to deliver therapeutic agents, such as gentamicin, to protect the healing process. I am looking forward to bringing my significant experience and expertise to drive the development of the Company’s product pipeline, which are designed to deliver the next generation CERAMENT products that will enhance bone growth that are clearly needed to address multiple orthopedic indications.” 

Notes to Editors

About BONESUPPORT™

BONESUPPORT is an innovative and rapidly growing commercial stage orthobiologics company, based in Lund, Sweden. The Company develops and commercializes innovative injectable bio-ceramic bone graft substitutes that remodel to the patient’s own bone and have the capability of eluting drugs directly into the bone void.

BONESUPPORT’s marketed bio-ceramic bone graft substitutes CERAMENT® BONE VOID FILLER (BVF), CERAMENT® G* and CERAMENT® V* are all based on the Company’s novel and proprietary CERAMENT technology platform.

The Company’s products are targeting a large addressable market opportunity across trauma, chronic osteomyelitis (bone infection), revision arthroplasty (replacement of a joint prosthesis) and infected diabetic foot.

BONESUPPORT’s total sales increased from SEK 41 million in 2014 to SEK 105 million in 2016, representing a compound annual growth rate of 60 percent. The Company’s financial target is to achieve revenue exceeding SEK 500 million in the financial year 2020, with a gross margin exceeding 85 percent and a positive operating profit.

The Company’s research and development is focused on the continuing development and refinement of its CERAMENT technology to extend its use into additional indications by the elution of other drugs and therapeutic agents. The Company currently has a pipeline of pre-clinical product candidates that have been designed to promote bone growth.

BONESUPPORT is listed on Nasdaq Stockholm and trades under the ticker “BONEX” (ISIN code: SE0009858152). Further information is available at bonesupport.com

*CERAMENT G: Not available in the United States, for investigational use only. CERAMENT V: Not available in the United States

BONESUPPORT™ and CERAMENT® are registered trademarks.

For more information contact:

Richard Davies, CEO

Tel: +46 (0) 46 286 53 71

 

Björn Westberg, CFO

Tel: +46 (0) 46 286 53 60

Email: ir@bonesupport.com

 

Citigate Dewe Rogerson

Pip Batty, David Dible, Marine Perrier

+44 (0)20 7282 1022

bonesupport@citigatedr.co.uk

Downloads

Press release PDF (481.24 KB)

BONESUPPORT™ SIGNS COMMERCIALIZATION AGREEMENT FOR THE FRENCH MARKET

7th September 2017

BONESUPPORT™ SIGNS COMMERCIALIZATION AGREEMENT FOR THE FRENCH MARKET

Lund, Sweden, 08.00 CEST, September 7th 2017 – BONESUPPORTTM, an emerging leader in innovative injectable bio-ceramic bone substitute products to treat bone voids caused by trauma, infection, disease or related surgery based on its unique CERAMENT® platform today announces that it has signed an Agency agreement with Novomedics to provide it with local support to initiate access to French market.

Novomedics, which is based in Metz, has significant experience in the bone substitute field. BONESUPPORT’s CERAMENT product line of CERAMENT BONE VOID FILLER (BVF), CERAMENT G and CERAMENT V will be commercialized by a national sales force composed of approximately 40 experienced representatives. These representatives have access to a network of potential customers in the orthopaedic sector. Novomedics is led by its Founder & CEO, Michael Class, MD, a French-trained physician.

This new French commercialization agreement means that BONESUPPORT’s products are now sold in 8 of the key European markets via specialty distributors. In addition, BONESUPPORT markets its products directly in 5 European countries the UK, Germany, Switzerland, Sweden and Denmark. BONESUPPORT has a commercial team of 20 people in Europe to support and drive the Company’s sales growth.

Richard Davies, CEO of BONESUPPORT, commented: “I am pleased that we have been able to sign this Commercialization agreement with Novomedics in order to initiate coverage of the French market for our highly differentiated injectable bio-ceramic bone substitute products.  We have been very impressed with their knowledge of the bone substitute market and their strong links with the orthopedic community. We look forward to a mutually beneficial relationship.”

 

 Notes to Editors

About BONESUPPORT™

BONESUPPORT is an innovative and rapidly growing commercial stage orthobiologics company, based in Lund, Sweden. The Company develops and commercializes innovative injectable bio-ceramic bone graft substitutes that remodel to the patient’s own bone and have the capability of eluting drugs directly into the bone void.

BONESUPPORT’s marketed bio-ceramic bone graft substitutes CERAMENT® BONE VOID FILLER (BVF), CERAMENT® G* and CERAMENT® V* are all based on the Company’s novel and proprietary CERAMENT technology platform.

The Company’s products are targeting a large addressable market opportunity across trauma, chronic osteomyelitis (bone infection), revision arthroplasty (replacement of a joint prosthesis) and infected diabetic foot.

BONESUPPORT’s total sales increased from SEK 41 million in 2014 to SEK 105 million in 2016, representing a compound annual growth rate of 60 percent. The Company’s financial target is to achieve revenue exceeding SEK 500 million in the financial year 2020, with a gross margin exceeding 85 percent and a positive operating profit.

The Company’s research and development is focused on the continuing development and refinement of its CERAMENT technology to extend its use into additional indications by the elution of other drugs and therapeutic agents. The Company currently has a pipeline of pre-clinical product candidates that have been designed to promote bone growth.

BONESUPPORT is listed on Nasdaq Stockholm and trades under the ticker “BONEX” (ISIN code: SE0009858152). Further information is available at bonesupport.com

*CERAMENT G: Not available in the United States, for investigational use only. CERAMENT V: Not available in the United States

BONESUPPORT™ and CERAMENT® are registered trademarks.

For more information contact:

Richard Davies, CEO

Tel: +46 (0) 46 286 53 71

 

Björn Westberg, CFO

Tel: +46 (0) 46 286 53 60

Email: ir@bonesupport.com

Downloads

Press release PDF (470.63 KB)

Change in number of shares and votes in BONESUPPORT HOLDING AB (publ)

31st August 2017

Change in number of shares and votes in BONESUPPORT HOLDING AB (publ)

Lund, Sweden, 31st August 2017 - During August, the number of shares and votes in BONESUPPORT HOLDING AB (publ) has increased due to the exercise of warrants. As of August 31, 2017, the number of shares and votes in BONESUPPORT HOLDING AB (publ) amounts to 49,382,244.

 

About BONESUPPORT®

BONESUPPORT is an innovative and rapidly growing commercial stage orthobiologics company, based in Lund, Sweden. The Company develops and commercializes innovative injectable bio-ceramic bone graft substitutes that remodel to the patient’s own bone and have the capability of eluting drugs directly into the bone void. BONESUPPORT’s marketed bio-ceramic bone graft substitutes CERAMENT® BONE VOID FILLER (BVF), CERAMENT® G* and CERAMENT® V* are all based on the Company’s novel and proprietary CERAMENT technology platform.

The Company’s products are targeting a large addressable market opportunity across trauma, chronic osteomyelitis (bone infection), revision arthroplasty (replacement of a joint prosthesis) and infected diabetic foot.

BONESUPPORT’s total sales increased from SEK 41 million in 2014 to SEK 105 million in 2016, representing a compound annual growth rate of 60 percent. The Company’s financial target is to achieve revenue exceeding SEK 500 million in the financial year 2020, with a gross margin exceeding 85 percent and a positive operating profit.

The Company’s research and development is focused on the continuing development and refinement of its CERAMENT technology to extend its use into additional indications by the elution of other drugs and therapeutic agents. The Company currently has a pipeline of pre-clinical product candidates that have been designed to promote bone growth.

BONESUPPORT is listed on Nasdaq Stockholm and trades under the ticker “BONEX” (ISIN code: SE0009858152). Further information is available at bonesupport.com

*CERAMENT G: Not available in the United States, for investigational use only. CERAMENT V: Not available in the United States.

BONESUPPORT™ and CERAMENT™ are registered trademarks.

 

For more information contact:

Richard Davies, CEO

Tel: +46 (0) 46 286 53 71

 

Björn Westberg, CFO

Tel: +46 (0) 46 286 53 60

Email: ir@bonesupport.com

The information in the press release is such that BONESUPPORT HOLDING AB (publ) is required to disclose pursuant to the Swedish Financial Instruments Trading Act. The information was submitted for publication, through the agency of the contact persons set out above, at 18:00 CET on August 31, 2017.

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Press release PDF (408.76 KB)

BONESUPPORT HOLDING AB (publ) - Interim Report January - June 2017

17th August 2017

BONESUPPORT HOLDING AB (publ) - Interim Report January - June 2017

Lund, Sweden, 08.00 CEST, 17 August 2017 – BONESUPPORTTM, an emerging leader in innovative injectable bio-ceramic bone substitute products to treat bone voids caused by trauma, infection, disease or related surgery based on its unique CERAMENT™ platform today publishes its Interim Report, January-June 2017.

 

FINANCIAL HIGHLIGHTS

Q2 Net sales increased by 48%

APRIL – JUNE 2017

  • Net Sales amounted to SEK 37.1 million (25.2), an increase of 48%
  • Gross margin of 87.2% (86.1) 
  • Operating loss of SEK -18.4 million (-20.8)
  • Earnings per share, before and after dilution was SEK -0.75 (-0.93)

JANUARY – JUNE 2017

  • Net Sales amounted to SEK 69.6 million (48.4), an increase of 44%
  • Gross margin of 88.0% (85.2)
  • Operating loss of SEK -45.8 million (-34.5)
  • Earnings per share, before and after dilution was SEK -1.82 (-1.62)

BUSINESS HIGHLIGHTS 

APRIL – JUNE 2017

  • BONESUPPORT HOLDING AB (publ) was listed 21st June at Nasdaq Stockholm and issued new shares raising SEK 500 million gross in conjunction with the IPO
  • BONESUPPORT’s FORTIFY study recruited its first patient
  • At the AGM, it was resolved to amend the Articles of association, change category into a public company and consolidate the shares 5:1
  • New executive recruitment: Michael Diefenbeck started as Chief Medical Officer

SIGNIFICANT EVENTS AFTER PERIOD END

• The over-allotment option, in relation to the IPO, allowed the Company to raise a further SEK 59 million. The total issue, including the over-allotment option, in conjunction with the IPO, was 19,827,585 shares raising a total of SEK 559 million before transaction costs.

Richard Davies, CEO of BONESUPPORT, commented: “BONESUPPORT has made significant progress in recent months. We successfully completed our IPO on Nasdaq Stockholm raising SEK 559 million, before expenses, and in parallel continued to drive the rapid adoption of our CERAMENT bio-ceramic bone substitute products to treat bone voids. We have also enrolled the first patient in the FORTIFY study which is key to potentially gaining approval for CERAMENT G* in the US. Our pipeline of new product candidates designed to enhance bone growth is continuing to making progress as we generate additional pre-clinical data and attract external grant funding. The multiple milestones that we have achieved in the first half of 2017, alongside the strengthening of our management team and the funding from our IPO mean that BONESUPPORT is now well placed to deliver its 2020 financial targets.”

 

The full Q2 Report is available by clicking on the links below:

Outside the US:https://bonesupport.com/en-eu/financial-reports-inv/ 

US:https://bonesupport.com/en-us/financial-reports-us/

 

The report will be available on BONESUPPORT’s website from 08:00 am CEST the same day and the presentation from the webcast will be uploaded during the day on the 17th August.

 

Conference Call

The Company will host a conference call and an online presentation at 10.00am CEST today.

The dial-in numbers for the conference call are:

UK: +44 20 30089802

SE: +46 85 6642694

US: +1 855 8315948

 

Webcast

The presentation will also be webcast and can be accessed from the following web address: http://www.financialhearings.com/event/10390  

Hosts: Richard Davies, CEO, and Björn Westberg, CFO

About BONESUPPORT™

BONESUPPORT is an innovative and rapidly growing commercial stage orthobiologics company, based in Lund, Sweden. The Company develops and commercializes innovative injectable bio-ceramic bone graft substitutes that remodel to the patient’s own bone and have the capability of eluting drugs directly into the bone void.

BONESUPPORT’s marketed bio-ceramic bone graft substitutes CERAMENT™ BONE VOID FILLER (BVF), CERAMENT™ G* and CERAMENT™ V* are all based on the Company’s novel and proprietary CERAMENT technology platform.

The Company’s products are targeting a large addressable market opportunity across trauma, chronic osteomyelitis (bone infection), revision arthroplasty (replacement of a joint prosthesis) and infected diabetic foot.

BONESUPPORT’s total sales increased from SEK 41 million in 2014 to SEK 105 million in 2016, representing a compound annual growth rate of 60 percent. The Company’s financial target is to achieve revenue exceeding SEK 500 million in the financial year 2020, with a gross margin exceeding 85 percent and a positive operating profit.

The Company’s research and development is focused on the continuing development and refinement of its CERAMENT technology to extend its use into additional indications by the elution of other drugs and therapeutic agents. The Company currently has a pipeline of pre-clinical product candidates that have been designed to promote bone growth.

BONESUPPORT is listed on Nasdaq Stockholm and trades under the ticker “BONEX” (ISIN code: SE0009858152). Further information is available at bonesupport.com

*CERAMENT G: Not available in the United States, for investigational use only. CERAMENT V: Not available in the United States

BONESUPPORT™ and CERAMENT™ are registered trademarks.

 

Contact Information

BONESUPPORT AB

Richard Davies, CEO
Tel: +46 (0) 46 286 53 70

Björn Westberg, CFO
Tel: +46 (0) 46 286 53 60
Email: ir@bonesupport.com

Citigate Dewe Rogerson

David Dible, Pip Batty, Marine Perrier
+44 (0)20 7638 9571
bonesupport@citigatedr.co.uk

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Press release PDF (428.66 KB)

BONESUPPORT™ - Q2 2017 Interim Report – invitation to conference call and webcast

11th August 2017

BONESUPPORT™ - Q2 2017 Interim Report – invitation to conference call and webcast

Lund, Sweden, 11 August 2017– BONESUPPORT AB, an emerging leader in innovative injectable bioceramic bone substitute products to treat bone voids caused by trauma, infection, disease or related surgery, will publish its Q2 2017 Interim Report on Thursday 17 August 2017 at 08:00 CEST.

 

The Company will also host a conference call and an online presentation on the same day at 10am CEST.

 

The dial-in numbers for the conference call are:

UK: +44 20 30089802

SE: +46 85 6642694

US: +1 855 8315948

 

The presentation will also be webcast and can be accessed from the following web address: http://www.financialhearings.com/event/10390

 

Hosts: Richard Davies, CEO, and Björn Westberg, CFO

 

 

Notes to Editor

About BONESUPPORT

BONESUPPORT is an innovative and rapidly growing commercial stage orthobiologics company, based in Lund, Sweden. The Company develops and commercializes innovative injectable bioceramic bone graft substitutes that remodel to the patient’s own bone and have the capability of eluting drugs directly into the bone void. BONESUPPORT’s marketed synthetic bone graft substitutes CERAMENT™ BONE VOID FILLER (BVF), CERAMENT™ G* and CERAMENT™ V* are all based on the Company’s novel and proprietary CERAMENT technology platform.

 

The Company’s products are targeting a large addressable market opportunity across trauma, chronic osteomyelitis (bone infection), revision arthroplasty (replacement of a joint prosthesis) and infected diabetic foot. The Company’s research and development is focused on the continuing development and refinement of its existing technology to extend its use into additional indications by the elution of other drugs and therapeutic agents.

 

BONESUPPORT’s products are based on an innovative technology backed by an intellectual property portfolio of approximately 100 registered and/or pending patents. BONESUPPORT has a nine year track record of safety and efficacy in treating patients with an estimated number of 30,000 procedures performed to date with its products worldwide based on sales data.

 

BONESUPPORT’s total sales increased from SEK 41 million in 2014 to SEK 105 million in 2016, representing a compound annual growth rate of 60 percent.

 

The Company’s financial target is to achieve revenue exceeding SEK 500 million in the financial year 2020, with a gross margin exceeding 85 percent and a positive operating profit.

BONESUPPORT was founded in 1999 by Prof. Lars Lidgren, an internationally respected scientist who has been the President of various musculoskeletal societies. BONESUPPORT’s mission is to bring people with bone and joint diseases back to an active life. The Company is listed on Nasdaq Stockholm and trades under the ticker “BONEX” (ISIN code: SE0009858152). Further information is available at bonesupport.com

*CERAMENT G: Not available in the United States, for investigational use only. CERAMENT V: Not available in the United States

BONESUPPORT™ is a registered trademark.

 

Contact Information

BONESUPPORT AB

Richard Davies, CEO

Tel: +46 (0) 46 286 53 70

 

Björn Westberg, CFO

Tel: +46 (0) 46 286 53 60

Email: ir@bonesupport.com  

 

Citigate Dewe Rogerson

David Dible, Pip Batty, Marine Perrier

+44 (0)20 7638 9571

bonesupport@citigatedr.co.uk

 

Downloads

Press release PDF (593.02 KB)

Change in number of shares and votes in BONESUPPORT HOLDING AB (publ)

31st July 2017

Change in number of shares and votes in BONESUPPORT HOLDING AB (publ)

During July, the number of shares and votes in BONESUPPORT HOLDING AB (publ) has increased due to the exercise of warrants and the new issue of shares that was made in connection with the exercise of the over-allotment option, subsequent to the listing of the Company’s shares on Nasdaq Stockholm. As of July 31, 2017, the number of shares and votes in BONESUPPORT HOLDING AB (publ) amounts to 49,138,735.

 

 

About BONESUPPORT

 

BONESUPPORT is an innovative and rapidly growing commercial stage orthobiologics company, based in Lund, Sweden. The Company develops and commercializes innovative injectable bioceramic bone graft substitutes that remodel to the patient’s own bone and have the capability of eluting drugs directly into the bone void. BONESUPPORT’s marketed synthetic bone graft substitutes CERAMENT™ BONE VOID FILLER (BVF), CERAMENT™ G and CERAMENT™ V* are all based on the Company’s novel and proprietary CERAMENT technology platform.

 

The Company’s products are targeting a large addressable market opportunity across trauma, chronic osteomyelitis (bone infection), revision arthroplasty (replacement of a joint prosthesis) and infected diabetic foot. The Company’s research and development is focused on the continuing development and refinement of its existing technology to extend its use into additional indications by the elution of other drugs and therapeutic agents.

 

BONESUPPORT’s products are based on an innovative technology backed by an intellectual property portfolio of approximately 100 registered and/or pending patents. BONESUPPORT has a nine year track record of safety and efficacy in treating patients with an estimated number of 30,000 procedures performed to date with its products worldwide based on sales data.

BONESUPPORT’s total sales increased from SEK 41 million in 2014 to SEK 105 million in 2016, representing a compound annual growth rate of 60 percent.

BONESUPPORT was founded in 1999 by Prof. Lars Lidgren, an internationally respected scientist. The Company is listed on Nasdaq Stockholm and trades under the ticker “BONEX” (ISIN code: SE0009858152). Further information is available at bonesupport.com

*CERAMENT G: Not available in the United States, for investigational use only. CERAMENT V: Not available in the United States.
BONESUPPORT™ is a registered trademark.  

 

For more information contact:  

Richard Davies, CEO

Tel: +46 (0) 46 286 53 71

 

Björn Westberg, CFO

Tel: +46 (0) 46 286 53 60

Email: ir@bonesupport.com  

 

The information in the press release is such that BONESUPPORT HOLDING AB (publ) is required to disclose pursuant to the Swedish Financial Instruments Trading Act. The information was submitted for publication, through the agency of the contact persons set out above, at 18:00 CET on July 31, 2017.

 

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Press release PDF (119.29 KB)

Exercise of over-allotment option and end of the stabilization period

21st July 2017

Exercise of over-allotment option and end of the stabilization period

NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, DIRECTLY OR INDIRECTLY, IN THE UNITED STATES OF AMERICA, AUSTRALIA, CANADA, JAPAN OR ANY OTHER JURISDICTION WHERE SUCH RELEASE, PUBLICATION OR DISTRIBUTION WOULD BE UNLAWFUL OR REQUIRE REGISTRATION OR ANY OTHER MEASURES

Stockholm, 21 July 2017

 

Carnegie Investment Bank AB (publ) (“Carnegie”) and ABG Sundal Collier AB (“ABGSC”) exercise the over-allotment option regarding 2,043,966 shares in BONESUPPORT HOLDING AB (publ) (“BONESUPPORT” or the “Company”) and notifies that stabilization measures have been undertaken in the Company’s shares on Nasdaq Stockholm. The stabilization period has now ended and no further stabilization transaction will be effected. 

As announced in connection with the offering to acquire newly issued shares in the Company and the listing of the Company’s shares on Nasdaq Stockholm (the ”Offering”), Carnegie and ABGSC may, acting as Joint Global Coordinators, carry out transactions aimed at supporting the market price of the shares at levels above those which might otherwise prevail in the open market.

Stabilization transactions may be undertaken on Nasdaq Stockholm, in the over-the-counter market or otherwise, at any time during the period starting on the date of commencement of trading in the shares on Nasdaq Stockholm and ending no later than 30 calendar days thereafter. Joint Global Coordinators are, however, not required to undertake any stabilization and there is no assurance that stabilization will be undertaken. Stabilization, if undertaken, may be discontinued at any time without prior notice. In no event will transactions be effected at levels above the price in the Offering.

The board of directors of the Company has granted Joint Global Coordinators an over-allotment option, which may be utilized in whole or in part for 30 days from the first date of trading in the Company’s shares on Nasdaq Stockholm, to issue up to 2,586,206 additional shares, corresponding to up to 15 percent of the total number of shares encompassed by the Offering, at a price corresponding to the price in the Offering, i.e. 29 SEK, to cover any over-allotment in connection with the Offering (the “Over-allotment option”). The Joint Global Coordinators now notify that the over-allotment option with respect to 2,043,966 shares has been exercised. The Company will thereby be provided with additionally approximately SEK 55 million, which means that the Company has been provided with approximately SEK 516 million as a result of the Offering, after issue expenses. Immediately following registration of the new shares issued pursuant to the Over-allotment option, the number of shares and votes in the Company will amount to 49,138,735. All shares in the Company that the Joint Global Coordinators have borrowed from Stiftelsen Industrifonden with the purpose of covering the over-allotment in the Offering will be returned within short. Following the exercise of the Over-allotment option, Stiftelsen Industrifonden and Lundbeckfond Invest A/S holds 4,787,806 shares in BONESUPPORT respectively, corresponding to approximately 9.7 percent respectively of the total shares outstanding in the Company. Due to the new share issue, Stiftelsen Industrifonden and Lundbeckfond Invest A/S have noted that their respective ownership will passively go below 10 percent.

Carnegie has, in its capacity as stabilization manager, notified that stabilization measures has been undertaken, in accordance with article 5(4) in the Market Abuse Regulation 596/2014, on Nasdaq Stockholm as specified below. The contact person at Carnegie is Anna Boqvist (tel: +46 8 588 688 00).

Stabilization information:

Issuer:

BONESUPPORT HOLDING AB (publ)

Securities:

Shares (SE0009858152)

Offering size:

17 241 379

Offer price:

29 SEK

Ticker:

BONEX

Stabilization manager:

Carnegie Investment Bank AB (publ)

 

 

Stabilization transactions:

Date

Quantity

Price (highest)

Price (lowest)

Price (volume weighted average)

Currency

Trading venue

2017-07-18

19,678

29,00

29,00

29,00

SEK

Nasdaq Stockholm

2017-07-19

33,173

29,00

29,00

29,00

SEK

Nasdaq Stockholm

2017-07-20

26,646

29,00

29,00

29,00

SEK

Nasdaq Stockholm

2017-07-21

19,181

29,00

29,00

29,00

SEK

Nasdaq Stockholm

The stabilization period regarding the Offering has now ended and no further stabilization transactions will be effected. Specified below is a summary of the stabilization transactions which have been effected during the stabilization period in accordance with this press release and the press releases as of 5 July and 17 July 2017, respectively. All transactions during the stabilization period have been effected on Nasdaq Stockholm and no stabilization transactions have been effected on other dates than those specified below.

Stabilization transactions:

Date

Quantity

Price (highest)

Price (lowest)

Price (volume weighted average)

Currency

Trading venue

2017-06-26

86,739

29,00

29,00

29,00

SEK

Nasdaq Stockholm

2017-06-27

35,200

29,00

29,00

29,00

SEK

Nasdaq Stockholm

2017-06-28

228,619

29,00

28,50

28,89

SEK

Nasdaq Stockholm

2017-06-29

4,098

28,60

28,50

28,55

SEK

Nasdaq Stockholm

2017-06-30

14,494

28,70

28,50

28,53

SEK

Nasdaq Stockholm

2017-07-03

678

28,50

28,50

28,50

SEK

Nasdaq Stockholm

2017-07-04

5,658

28,50

28,50

28,50

SEK

Nasdaq Stockholm

2017-07-05

4,871

28,50

28,50

28,50

SEK

Nasdaq Stockholm

2017-07-06

17,816

28,50

28,50

28,50

SEK

Nasdaq Stockholm

2017-07-07

6,708

28,50

28,50

28,50

SEK

Nasdaq Stockholm

2017-07-10

22,451

28,50

28,50

28,50

SEK

Nasdaq Stockholm

2017-07-11

12,414

28,60

28,50

28,54

SEK

Nasdaq Stockholm

2017-07-12

1,775

28,50

28,50

28,50

SEK

Nasdaq Stockholm

2017-07-13

2,041

28,60

28,60

28,60

SEK

Nasdaq Stockholm

2017-07-18

19,678

29,00

29,00

29,00

SEK

Nasdaq Stockholm

2017-07-19

33,173

29,00

29,00

29,00

SEK

Nasdaq Stockholm

2017-07-20

26,646

29,00

29,00

29,00

SEK

Nasdaq Stockholm

2017-07-21

19,181

29,00

29,00

29,00

SEK

Nasdaq Stockholm


This information is information that BONESUPPORT HOLDING AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation 596/2014. The information was submitted for publication, through the agency of the contact person set out below, at 19:30 CET on 21 July 2017.
 

 

 

About BONESUPPORT

 

BONESUPPORT is an innovative and rapidly growing commercial stage orthobiologics company, based in Lund, Sweden. The Company develops and commercializes innovative injectable bioceramic bone graft substitutes that remodel to the patient’s own bone and have the capability of eluting drugs directly into the bone void. BONESUPPORT’s marketed synthetic bone graft substitutes CERAMENT™ BONE VOID FILLER (BVF), CERAMENT™ G and CERAMENT™ V* are all based on the Company’s novel and proprietary CERAMENT technology platform.

 

The Company’s products are targeting a large addressable market opportunity across trauma, chronic osteomyelitis (bone infection), revision arthroplasty (replacement of a joint prosthesis) and infected diabetic foot. The Company’s research and development is focused on the continuing development and refinement of its existing technology to extend its use into additional indications by the elution of other drugs and therapeutic agents.

 

BONESUPPORT’s products are based on an innovative technology backed by an intellectual property portfolio of approximately 100 registered and/or pending patents. BONESUPPORT has a nine year track record of safety and efficacy in treating patients with an estimated number of 30,000 procedures performed to date with its products worldwide based on sales data.

BONESUPPORT’s total sales increased from SEK 41 million in 2014 to SEK 105 million in 2016, representing a compound annual growth rate of 60 percent.

The Company’s financial target is to achieve revenue exceeding SEK 500 million in the financial year 2020, with a gross margin exceeding 85 percent and a positive operating profit.

*CERAMENT G: Not available in the United States, for investigational use only. CERAMENT V: Not available in the United States.

 

For more information contact: 

 

Richard Davies, CEO

Tel: +46 (0) 46 286 53 71

Email: richard.davies@bonesupport.com

 

Björn Westberg, CFO

Tel: +46 (0) 46 286 53 60

Email: bjorn.westberg@bonesupport.com   

 

Important information

This announcement is not and does not form a part of any offer for sale of securities.

Copies of this announcement are not being made and may not be distributed or sent into the United States, Australia, Canada, Japan or any other jurisdiction in which such distribution would be unlawful or would require registration or other measures. The securities referred to in this announcement have not been and will not be registered under the U.S. Securities Act of 1933, as amended (the “Securities Act”), and accordingly may not be offered or sold in the United States absent registration or an exemption from the registration requirements of the Securities Act and in accordance with applicable U.S. state securities laws. The Company does not intend to register any offering in the United States or to conduct a public offering of securities in the United States.

The offering of securities referred to in this announcement has been made by means of a prospectus. This announcement is not a prospectus for the purposes of Directive 2003/71/EC (together with any applicable implementing measures in any Member State, the “Prospectus Directive”). Investors should not invest in any securities referred to in this announcement except on the basis of information contained in the aforementioned prospectus.

 

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Press release PDF (197.92 KB)

Stabilization notice

17th July 2017

Stabilization notice

NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, DIRECTLY OR INDIRECTLY, IN THE UNITED STATES OF AMERICA, AUSTRALIA, CANADA, JAPAN OR ANY OTHER JURISDICTION WHERE SUCH RELEASE, PUBLICATION OR DISTRIBUTION WOULD BE UNLAWFUL OR REQUIRE REGISTRATION OR ANY OTHER MEASURES

Stockholm, 17 July 2017

 

Carnegie Investment Bank AB (”Carnegie”) notifies that stabilization measures have been undertaken in BONESUPPORT Holding AB’s (publ) (“BONESUPPORT” or the “Company”) shares traded on Nasdaq Stockholm

 

As announced in connection with the offering to acquire newly issued shares in the Company and the listing of the Company’s shares on Nasdaq Stockholm (the ”Offering”), Carnegie and ABG Sundal Collier AB may, acting as Joint Global Coordinators, carry out transactions aimed at supporting the market price of the shares at levels above those which might otherwise prevail in the open market.

 

Stabilization transactions may be undertaken on Nasdaq Stockholm, in the over-the-counter market or otherwise, at any time during the period starting on the date of commencement of trading in the shares on Nasdaq Stockholm and ending no later than 30 calendar days thereafter. Joint Global Coordinators are, however, not required to undertake any stabilization and there is no assurance that stabilization will be undertaken. Stabilization, if undertaken, may be discontinued at any time without prior notice. In no event will transactions be effected at levels above the price in the Offering.

 

The board of directors of the Company has granted Joint Global Coordinators an over-allotment option, which may be utilized in whole or in part for 30 days from the first date of trading in the Company’s shares on Nasdaq Stockholm, to issue up to 2,586,206 additional shares, corresponding to up to 15 percent of the total number of shares encompassed by the Offering, at a price corresponding to the price in the Offering, i.e. 29 SEK, to cover any over-allotment in connection with the Offering.

 

Carnegie has, in its capacity as stabilization manager, notified that stabilization measures has been undertaken, in accordance with article 5(4) in the Market Abuse Regulation 596/2014, on Nasdaq Stockholm as specified below. Undertaken stabilization measures were also announced on 5 July 2017. The contact person at Carnegie is Anna Boqvist (tel: +46 8 588 688 00).

 

Stabilization information:

Issuer:

BONESUPPORT Holding AB (publ)

Securities:

Shares (SE0009858152)

Offering size:

17 241 379

Offer price:

29 SEK

Ticker:

BONEX

Stabilization manager:

Carnegie Investment Bank AB (publ)

 

Stabilization transactions:

Date

Quantity

Price (highest)

Price (lowest)

Price (volume weighted average)

Currency

Trading venue

2017-07-06

17 816

28,50

28,50

28,50

SEK

Nasdaq Stockholm

2017-07-07

6 708

28,50

28,50

28,50

SEK

Nasdaq Stockholm

2017-07-10

22 451

28,50

28,50

28,50

SEK

Nasdaq Stockholm

2017-07-11

12 414

28,60

28,50

28,54

SEK

Nasdaq Stockholm

2017-07-12

1 775

28,50

28,50

28,50

SEK

Nasdaq Stockholm

2017-07-13

2 041

28,60

28,60

28,60

SEK

Nasdaq Stockholm

 

This information is information that BONESUPPORT Holding AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation 596/2014. The information was submitted for publication, through the agency of the contact person set out below, at 17 July CET on 19.00 2017.  

 

For further information, please contact: 

 

Björn Westberg, CFO BONESUPPORT, tel: +46 (0) 46 286 53 60, ir@bonesupport.com 

 

Important information 

This announcement is not and does not form a part of any offer for sale of securities.

Copies of this announcement are not being made and may not be distributed or sent into the United States, Australia, Canada, Japan or any other jurisdiction in which such distribution would be unlawful or would require registration or other measures. The securities referred to in this announcement have not been and will not be registered under the U.S. Securities Act of 1933, as amended (the “Securities Act”), and accordingly may not be offered or sold in the United States absent registration or an exemption from the registration requirements of the Securities Act and in accordance with applicable U.S. state securities laws. The Company does not intend to register any offering in the United States or to conduct a public offering of securities in the United States. 

The offering of securities referred to in this announcement has been made by means of a prospectus. This announcement is not a prospectus for the purposes of Directive 2003/71/EC (together with any applicable implementing measures in any Member State, the “Prospectus Directive”). Investors should not invest in any securities referred to in this announcement except on the basis of information contained in the aforementioned prospectus.

 

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BONESUPPORT™ - Pipeline Project Targeting Bioceramics Capable of Enhancing Bone Growth Awarded SEK 8 million Grant from Vinnova Sweden

12th July 2017

BONESUPPORT™ - Pipeline Project Targeting Bioceramics Capable of Enhancing Bone Growth Awarded SEK 8 million Grant from Vinnova Sweden

Lund, Sweden, 12 July 2017– BONESUPPORT AB, an emerging leader in innovative injectable bioceramic bone substitute products to treat bone voids caused by trauma, infection, disease or related surgery, announced today that one of the components of its pipeline projects focused on developing a new CERAMENT™ product capable of enhancing bone growth has been awarded SEK 8 million in external funding from Sweden’s innovation agency Vinnova. 

 

The project titled Developing Functionalized Biomaterials with Bone Active Molecules as Novel Strategies/Tools for Secondary Prevention and Treatment of Osteoporotic Fragility Fractures will be conducted by an Indo-Swedish university research group. The project’s Principal Investigators are:

 

•  Professor Magnus Tägil, Department of  Orthopedics, Lund University, Lund, Sweden

 

•  Professor Ashok Kumar, Department of Biological Sciences and Bioengineering, Indian Institute of Technology Kanpur, UP

 

Professor Lars Lidgren, the founder of BONESUPPORT, and Professor Hanna Isaksson - both from Lund University - will be co-Principal Investigators of the project. Dr Eva Lidén, BONESUPPORT’s Head of R&D, will also contribute her expertise.

 

The project will evaluate a combination of biphasic ceramics, bone active molecules and the body’s own cells to regenerate bone and improve mechanical strength in osteoporotic subjects.

 

One of the goals is to assess the capability of CERAMENT™|G, a bone graft substitute that elutes the antibiotic gentamicin, to deliver a combination of bone morphogenic protein-2 to induce bone formation and zoledronic acid to decrease secondary bone resorption.

Richard Davies, CEO of BONESUPPORT said, ”I am pleased that this Indo-Swedish research group, which is focused on developing novel CERAMENT products, has received this significant funding grant. If successful, this project will help us accelerate the development of products in our pipeline which is focused on delivering improved treatment options for osteoporotic fractures.  We are confident that a new CERAMENT product which can deliver agents that enhance bone growth will be very attractive commercially.”

 

About BONESUPPORT

BONESUPPORT is an innovative and rapidly growing commercial stage orthobiologics company, based in Lund, Sweden. The Company develops and commercializes innovative injectable bioceramic bone graft substitutes that remodel to the patient’s own bone and have the capability of eluting drugs directly into the bone void. BONESUPPORT’s marketed synthetic bone graft substitutes CERAMENT™ BONE VOID FILLER (BVF), CERAMENT™ G* and CERAMENT™ V* are all based on the Company’s novel and proprietary CERAMENT technology platform.

 

The Company’s products are targeting a large addressable market opportunity across trauma, chronic osteomyelitis (bone infection), revision arthroplasty (replacement of a joint prosthesis) and infected diabetic foot. The Company’s research and development is focused on the continuing development and refinement of its existing technology to extend its use into additional indications by the elution of other drugs and therapeutic agents.

 

BONESUPPORT’s products are based on an innovative technology backed by an intellectual property portfolio of approximately 100 registered and/or pending patents. BONESUPPORT has a nine year track record of safety and efficacy in treating patients with an estimated number of 30,000 procedures performed to date with its products worldwide based on sales data.

 

BONESUPPORT’s total sales increased from SEK 41 million in 2014 to SEK 105 million in 2016, representing a compound annual growth rate of 60 percent. 

BONESUPPORT was founded in 1999 by Prof. Lars Lidgren, an internationally respected scientist. The Company is listed on Nasdaq Stockholm and trades under the ticker “BONEX” (ISIN code: SE0009858152). Further information is available at bonesupport.com

*CERAMENT G: Not available in the United States, for investigational use only. CERAMENT V: Not available in the United States. 

 

BONESUPPORT™ is a registered trademark.  

 

Contact Information

BONESUPPORT AB

 

Richard Davies, CEO

Tel: +46 (0) 46 286 53 70

 

Björn Westberg, CFO

Tel: +46 (0) 46 286 53 60

Email: ir@bonesupport.com

 

Citigate Dewe Rogerson

David Dible, Mark Swallow, Marine Perrier

Tel: +44 (0)20 7638 9571

Email: bonesupport@citigatedr.co.uk

 

 

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Stabilization notice

5th July 2017

Stabilization notice

NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, DIRECTLY OR INDIRECTLY, IN THE UNITED STATES OF AMERICA, AUSTRALIA, CANADA, JAPAN OR ANY OTHER JURISDICTION WHERE SUCH RELEASE, PUBLICATION OR DISTRIBUTION WOULD BE UNLAWFUL OR REQUIRE REGISTRATION OR ANY OTHER MEASURES

Stockholm, 5 July 2017

Carnegie Investment Bank AB (”Carnegie”) notifies that stabilization measures have been undertaken in BONESUPPORT Holding AB’s (publ) (“BONESUPPORT” or the “Company”) shares traded on Nasdaq Stockholm

As announced in connection with the offering to acquire newly issued shares in the Company and the listing of the Company’s shares on Nasdaq Stockholm (the ”Offering”), Carnegie and ABG Sundal Collier AB may, acting as Joint Global Coordinators, carry out transactions aimed at supporting the market price of the shares at levels above those which might otherwise prevail in the open market.

Stabilization transactions may be undertaken on Nasdaq Stockholm, in the over-the-counter market or otherwise, at any time during the period starting on the date of commencement of trading in the shares on Nasdaq Stockholm and ending no later than 30 calendar days thereafter. Joint Global Coordinators are, however, not required to undertake any stabilization and there is no assurance that stabilization will be undertaken. Stabilization, if undertaken, may be discontinued at any time without prior notice. In no event will transactions be effected at levels above the price in the Offering.

The board of directors of the Company has granted Joint Global Coordinators an over-allotment option, which may be utilized in whole or in part for 30 days from the first date of trading in the Company’s shares on Nasdaq Stockholm, to issue up to 2,586,206 additional shares, corresponding to up to 15 percent of the total number of shares encompassed by the Offering, at a price corresponding to the price in the Offering, i.e. 29 SEK, to cover any over-allotment in connection with the Offering.

Carnegie has, in its capacity as stabilization manager, notified that stabilization measures has been undertaken, in accordance with article 5(4) in the Market Abuse Regulation 596/2014, on Nasdaq Stockholm as specified below. The contact person at Carnegie is Anna Boqvist (tel: +46 8 588 688 00).

 

 

 

Stabilization information:

Issuer:

BONESUPPORT Holding AB (publ)

Securities:

Shares (SE0009858152)

Offering size:

17 241 379

Offer price:

29 SEK

Ticker:

BONEX

Stabilization manager:

Carnegie Investment Bank AB (publ)

 

Stabilization transactions:

Date

Quantity

Price (highest)

Price (lowest)

Price (volume weighted average)

Currency

Trading venue

2017-06-26

86 739

29,00

29,00

29,00

SEK

Nasdaq Stockholm

2017-06-27

35 200

29,00

29,00

29,00

SEK

Nasdaq Stockholm

2017-06-28

228 619

29,00

28,50

28,89

SEK

Nasdaq Stockholm

2017-06-29

4 098

28,60

28,50

28,55

SEK

Nasdaq Stockholm

2017-06-30

14 494

28,70

28,50

28,53

SEK

Nasdaq Stockholm

2017-07-03

678

28,50

28,50

28,50

SEK

Nasdaq Stockholm

2017-07-04

5 658

28,50

28,50

28,50

SEK

Nasdaq Stockholm

2017-06-05

4 871

28,50

28,50

28,50

SEK

Nasdaq Stockholm

 

This information is information that BONESUPPORT Holding AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation 596/2014. The information was submitted for publication, through the agency of the contact person set out below, at 5 July CET on 19.00 2017. 

 

For further information, please contact: 

 

Björn Westberg, CFO BONESUPPORT

Tel: +46 (0) 46 286 53 60

Email: ir@bonesupport.com 

 

Important information

 

This announcement is not and does not form a part of any offer for sale of securities.

 

Copies of this announcement are not being made and may not be distributed or sent into the United States, Australia, Canada, Japan or any other jurisdiction in which such distribution would be unlawful or would require registration or other measures. The securities referred to in this announcement have not been and will not be registered under the U.S. Securities Act of 1933, as amended (the “Securities Act”), and accordingly may not be offered or sold in the United States absent registration or an exemption from the registration requirements of the Securities Act and in accordance with applicable U.S. state securities laws. The Company does not intend to register any offering in the United States or to conduct a public offering of securities in the United States.

 

The offering of securities referred to in this announcement has been made by means of a prospectus. This announcement is not a prospectus for the purposes of Directive 2003/71/EC (together with any applicable implementing measures in any Member State, the “Prospectus Directive”). Investors should not invest in any securities referred to in this announcement except on the basis of information contained in the aforementioned prospectus.

 

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Change in number of shares and votes in BONESUPPORT HOLDING AB (publ)

30th June 2017

Change in number of shares and votes in BONESUPPORT HOLDING AB (publ)

During June, the number of shares and votes in BONESUPPORT HOLDING AB (publ) has increased due to the new issue of shares that was made in connection with the listing of the company’s shares on Nasdaq Stockholm. As of June 30, 2017, the number of shares and votes in BONESUPPORT HOLDING AB (publ) amounts to 46,252,600.

 

About BONESUPPORT

BONESUPPORT is an innovative and rapidly growing commercial stage orthobiologics company, based in Lund, Sweden. The Company develops and commercializes innovative injectable bioceramic bone graft substitutes that remodel to the patient’s own bone and have the capability of eluting drugs directly into the bone void. BONESUPPORT’s marketed synthetic bone graft substitutes CERAMENT™ BONE VOID FILLER (BVF), CERAMENT™ G and CERAMENT™ V1 are all based on the Company’s novel and proprietary CERAMENT technology platform.

 

The Company’s products are targeting a large addressable market opportunity across trauma, chronic osteomyelitis (bone infection), revision arthroplasty (replacement of a joint prosthesis) and infected diabetic foot. The Company’s research and development is focused on the continuing development and refinement of its existing technology to extend its use into additional indications by the elution of other drugs and therapeutic agents.

 

BONESUPPORT’s products are based on an innovative technology backed by an intellectual property portfolio of approximately 100 registered and/or pending patents. BONESUPPORT has a nine year track record of safety and efficacy in treating patients with an estimated number of 30,000 procedures performed to date with its products worldwide based on sales data.

 

BONESUPPORT’s total sales increased from SEK 41 million in 2014 to SEK 105 million in 2016, representing a compound annual growth rate of 60 percent. The Company’s financial target is to achieve revenue exceeding SEK 500 million in the financial year 2020, with a gross margin exceeding 85 percent and a positive operating profit. 

 

1CERAMENT G: Not available in the United States, for investigational use only. CERAMENT V: Not available in the United States. 

  

For more information contact:

Richard Davies, CEO

Tel: +46 (0) 46 286 53 70

 

Björn Westberg, CFO

Tel: +46 (0) 46 286 53 60

Email: ir@bonesupport.com

 

The information in the press release is such that BONESUPPORT HOLDING AB (publ) is required to disclose pursuant to the Swedish Financial Instruments Trading Act. The information was submitted for publication, through the agency of the contact persons set out above, at 09:30 CET on June 30, 2017.

 

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Final price in BONESUPPORT™’s initial public offering set at SEK 29 per share – trading on Nasdaq Stockholm commences today

21st June 2017

Final price in BONESUPPORT™’s initial public offering set at SEK 29 per share – trading on Nasdaq Stockholm commences today

NOT FOR RELEASE, DISTRIBUTION OR PUBLICATION, DIRECTLY OR INDIRECTLY, IN THE UNITED STATES OF AMERICA, AUSTRALIA, CANADA, JAPAN OR ANY OTHER JURISDICTION IN WHICH THE RELEASE, DISTRIBUTION OR PUBLICATION WOULD BE UNLAWFUL OR REQUIRE REGISTRATION OR ANY OTHER MEASURE

Stockholm, 21 June, 2017 

BONESUPPORT HOLDING AB (publ) (“BONESUPPORT” or the “Company”) hereby announces the outcome of the offering of newly issued shares in the Company (the “Offering”) and its listing on Nasdaq Stockholm. The Offering attracted strong interest among Swedish and international investors and the Offering was oversubscribed several times.

The Offering

•  The final price of the Offering has been set at SEK 29 per share, corresponding to a market capitalization of SEK 1,416 million based on the total number of outstanding shares in BONESUPPORT following the Offering, providing the Over-allotment option (defined below) is fully utilized.

•  In total, 17,241,379 new shares in BONESUPPORT are issued in the Offering, corresponding to issue proceeds of SEK 500 million in total before issue costs and SEK 461 million after issue costs.

•  Furthermore, the Company has issued an over-allotment option (the “Over-allotment option”) of 2,586,206 new shares, corresponding to SEK 75 million and 15 percent of the total number of shares in the Offering.

•  The total number of shares in BONESUPPORT after the Offering will amount to 46,252,600 shares if the Over-allotment option is not utilized, and 48,838,806 shares if the Over-allotment option is fully utilized.

•  Through the Offering, the Cornerstone Investor Swedbank Robur Fonder AB as well as the existing shareholders HealthCap V L.P., Stiftelsen Industrifonden, Lundbeckfond Invest A/S, Carl Westin Ltd, Tredje AP-fonden, Tellacq AB, OFP V Advisor AB and Arctic Funds PLC have together agreed to acquire shares in line with their commitments of SEK 236 million. This corresponds to approximately 41.0 percent of the number of shares in the Offering, assuming a full exercise of the Over-allotment option.

•  Immediately following the completion of the Offering, and assuming that the Over-Allotment option is exercised in full, BONESUPPORT’s largest shareholders will include HealthCap V L.P (13.5 %), Stiftelsen Industrifonden (9.8 %), Lundbeckfond Invest A/S (9.8 %), Swedbank Robur Fonder AB (9.2 %), Tredje AP-fonden (8.3 %), Carl Westin Ltd. (5.5 %) and Tellacq AB (5.3 %).

•  Trading in the Company’s shares on Nasdaq Stockholm commences today, 21 June 2017, under the ticker “BONEX” (ISIN code: SE0009858152).

•  Trading is conditional until the settlement day, which is expected to be 26 June 2017. 

 

“I am delighted with the strong support we have generated from both new investors, including Swedbank Robur, and our existing investors. The backing of these high quality investors highlights the significant potential of BONESUPPORT’s CERAMENT™ products,” commented Richard Davies, CEO of BONESUPPORT. “Our IPO will provide us with the funds we need to execute our strategy of driving sales in both the US and Europe, generating additional clinical data to enhance the competitive positioning of our products and completing the FORTIFY study, which is key to gaining US approval for CERAMENT G. Our stronger financial position will also allow us to invest in our pipeline of new products that are designed to promote bone growth. This strategy provides the foundation for our 2020 financial targets and will allow us to generate significant value for our shareholders.”

 

About BONESUPPORT

BONESUPPORT is an innovative and rapidly growing commercial stage orthobiologics company, based in Lund, Sweden. The Company develops and commercializes innovative injectable bioceramic bone graft substitutes that remodel to the patient’s own bone and have the capability of eluting drugs directly into the bone void. BONESUPPORT’s marketed synthetic bone graft substitutes CERAMENT™ BONE VOID FILLER (BVF), CERAMENT™ G and CERAMENT™ V1 are all based on the Company’s novel and proprietary CERAMENT technology platform.

 

The Company’s products are targeting a large addressable market opportunity across trauma, chronic osteomyelitis (bone infection), revision arthroplasty (replacement of a joint prosthesis) and infected diabetic foot. The Company’s research and development is focused on the continuing development and refinement of its existing technology to extend its use into additional indications by the elution of other drugs and therapeutic agents.

 

BONESUPPORT’s products are based on an innovative technology backed by an intellectual property portfolio of approximately 100 registered and/or pending patents. BONESUPPORT has a nine year track record of safety and efficacy in treating patients with an estimated number of 30,000 procedures performed to date with its products worldwide based on sales data.

 

BONESUPPORT’s total sales increased from SEK 41 million in 2014 to SEK 105 million in 2016, representing a compound annual growth rate of 60 percent.

 

The Company’s financial target is to achieve revenue exceeding SEK 500 million in the financial year 2020, with a gross margin exceeding 85 percent and a positive operating profit. 

 

1CERAMENT G: Not available in the United States, for investigational use only. CERAMENT V: Not available in the United States. 

 

Advisors

Carnegie Investment Bank AB (publ) and ABG Sundal Collier AB are acting as Joint Global Coordinators and Joint Bookrunners in the Offering. Setterwalls Advokatbyrå AB is legal advisor to the Company. Baker & McKenzie Advokatbyrå KB is legal adviser to the Joint Global Coordinators and Joint Bookrunners.

 

For more information contact:

Richard Davies, CEO

Tel: +46 (0) 46 286 53 71

Email: richard.davies@bonesupport.com

 

Björn Westberg, CFO

Tel: +46 (0) 46 286 53 60

Email: bjorn.westberg@bonesupport.com

 

Important information

This announcement is not an offer to sell or a solicitation of any offer to buy any securities issued by BONESUPPORT HOLDING AB (publ) in any jurisdiction where such offer or sale would be unlawful. 

This announcement and the information contained herein is not for distribution in or into the United States, Australia, Canada, Japan or any other jurisdiction in which such distribution would be unlawful or would require registration or other measures. The securities referred to in this announcement have not been and will not be registered under the U.S. Securities Act of 1933, as amended (the “Securities Act”), and accordingly may not be offered or sold in the United States absent registration or an exemption from the registration requirements of the Securities Act and in accordance with applicable U.S. state securities laws. The Company does not intend to register any offering in the United States or to conduct a public offering of securities in the United States.

In any EEA Member State, other than Sweden, that has implemented Directive 2003/71/EC as amended (together with any applicable implementing measures in any member State, the “Prospectus Directive”), this communication is only addressed to and is only directed at qualified investors in that Member State within the meaning of the Prospectus Directive.

In the United Kingdom, this announcement and the information that this announcement contains is only directed at persons in the United Kingdom that are (i) investment professionals falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (the “Order”) or (ii) high net worth entities, and other persons to whom this announcement may lawfully be communicated, falling within Article 49(2)(a) to (d) of the Order (all such persons together being referred to as “Relevant Persons”). This communication must not be acted on or relied on by persons who are not Relevant Persons. Any investment or investment activity to which this communication relates is available only to Relevant Persons and will be engaged in only with Relevant Persons. Persons distributing this communication must satisfy themselves that it is lawful to do so.

Any offering of the securities referred to in this announcement will be made by means of a prospectus. This announcement is not a prospectus for the purposes of the Prospectus Directive. A prospectus prepared in accordance with the Prospectus Directive has been published and is held available at bonesupport.com. Investors should not subscribe for any securities referred to in this announcement except on the basis of information contained in the aforementioned prospectus.

Certain matters discussed in this announcement constitute forward-looking statements. Forward looking statements are statements that are not historical facts and may be identified by words such as “believe”, “expect”, “anticipate”, “intends”, “estimate”, “will”, “may”, "continue", “should” and similar expressions. The forward-looking statements in this release are based upon various assumptions, many of which are based, in turn, upon further assumptions. Although the Company believes that these assumptions were reasonable when made, these assumptions are inherently subject to significant known and unknown risks, uncertainties, contingencies and other important factors which are difficult or impossible to predict and are beyond its control. Such risks, uncertainties, contingencies and other important factors could cause actual events to differ materially from the expectations expressed or implied in this release by such forward-looking statements. The information, opinions and forward-looking statements contained in this announcement speak only as at its date, and are subject to change without notice. 

In connection with the offer or sale of securities referred to herein, the Joint Global Coordinators may overallot securities/conduct stabilization or effect transactions with a view to supporting the market price of the securities at a level higher than that which might otherwise prevail. Any stabilization action or over-allotment will be conducted by the Joint Global Coordinators in accordance with all applicable laws and rules.

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BONESUPPORT™ Announces First Patient Enrolled in FORTIFY Trial with CERAMENT®|G, a novel injectable, antibiotic-eluting bone graft substitute

22nd May

BONESUPPORT™ Announces First Patient Enrolled in FORTIFY Trial with CERAMENT®|G, a novel injectable, antibiotic-eluting bone graft substitute

FORTIFY trial to assess CERAMENT G as part of the surgical repair of severe tibial fractures 

Lund, Sweden, 22 May 2017– BONESUPPORT AB, an emerging leader in innovative injectable bioceramic bone substitute products to treat bone voids caused by trauma, infection, disease or related surgery, today announced that the first patient has been enrolled by Dr Ravi Karia at the  University of Texas Health Science Center at San Antonio into the company's pivotal Investigational Device Exemption (IDE) trial:  A Prospective, Randomized, Multicenter Controlled Trial of CERAMENT G as Part of Surgical Repair of Open Diaphyseal Tibial Fractures(the FORTIFY trial: ClinicalTrials.gov Identifier: NCT02820363).

CERAMENT G is an injectable antibiotic-eluting bone graft substitute that has proven remodeling capabilities and provides local sustained delivery of gentamicin.  The data from the trial will support BONESUPPORT’s PMA (Premarket Approval) filing for CERAMENT G   in the US.

In spite of modern day care of open tibial fractures, bone loss  coupled with wound contamination and soft tissue damage continue to impair healing and recovery, particularly if infection develops. In addition, open tibial fractures result in a general infirmity, long-term disability and reduction in quality of life for patients, and a significant clinical challenge for orthopedic surgeons. 

The FORTIFY trial will assess CERAMENT G’s ability to improve on the standard-of-care management of patients with open fractures of the tibial diaphysis. The primary endpoints of the trial will include the absence of deep infection at the fracture site and the lack of secondary procedures intended to promote fracture union.  The trial will also evaluate the safety of CERAMENT G in these patients. The trial will enroll up to 230 patients at up to 30 centers in the US and Europe.

Dr. Douglas Dirschl, the trial’s Principal Investigator, said: “I am excited to take part in the FORTIFY clinical trial. The open tibial fracture remains the most common and one of the most troublesome open fractures managed by orthopedic surgeons. Even with modern treatment protocols, patients suffering this fracture continue to be at substantial risk of infection, fracture non-union, and prolonged disability. A product that could be inserted into the fracture site at the time of definitive treatment that could promote bone formation at the same time as reducing the risk of subsequent infection, would be a major advance in the treatment of these troublesome fractures and would have the potential to provide benefit to thousands of patients each year in the United States.”

Douglas R. Dirschl, MD is the Lowell T. Coggeshall Professor of Orthopedic Surgery and Chairman, Department of Orthopedic Surgery and Rehabilitation Medicine at The University of Chicago Medicine.

“The treatment of the first patient in the FORTIFY trial is another key corporate milestone for BONESUPPORT.  This clinical trial in a complex trauma indication is designed to demonstrate proof-of-concept that CERAMENT G can be used to improve and protect the healing process in open bone fractures in combination with standard procedures, minimizing the risk of deep infections which would result in the need for additional remedial procedures,” added Richard Davies, CEO of BONESUPPORT. “We plan to use the clinical data to support our planned PMA filing for CERAMENT G in the US. We also intend to generate additional clinical data with CERAMENT G to gain a broad US label for this novel, injectable antibiotic-eluting bone graft substitute, which is rapidly being adopted in Europe. 

CERAMENT G combines the bone healing and bone remodeling properties of CERAMENT with the antibiotic, gentamicin. CERAMENT G drug-eluting properties enable it to provide an initial high concentration of gentamicin to the environment of the bone fracture and then a longer sustainable dose above the minimum inhibitory concentration of many of the bacteria that could cause a bone infection at the fracture site. This unique antibiotic-eluting profile helps protect the bone healing process and to promote bone remodeling.

CERAMENT G received the European CE Mark in February 2013 and is now marketed in 19 countries outside the US.

Ends

Notes to Editor

About BONESUPPORT™

BONESUPPORT AB has developed CERAMENT™ as an innovative range of radiopaque injectable osteoconductive bioceramic products that have a proven ability to heal defects by remodeling to host bone in six to twelve months. Our products are effective in treating patients with fractures and bone voids caused by trauma, infection, disease or related surgery. Our lead product, CERAMENT™|BONE VOID FILLER (BVF) addresses important issues facing health care providers, such as avoiding hospital readmissions and revision surgery that result from failed bone healing and infection caused by residual bone voids. CERAMENT|BVF is commercially available in the U.S., EU, S.E. Asia and the Middle East.

CERAMENT's distinctive properties as a drug eluting material have been validated in clinical practice by CERAMENT™|G and CERAMENT™ V, the first CE-marked injectable antibiotic eluting bone graft substitutes. These products provide local sustained delivery of gentamicin and vancomycin, respectively. The local delivery feature enables an initial high concentration of antibiotics to the bone defect and then a longer sustainable dose above the minimal inhibitory concentration (MIC) to protect bone healing and promote bone remodeling.

CERAMENT|G and CERAMENT™ have demonstrated good results in patients with problematic bone infections including osteomyelitis. They are also used prophylactically in patients who are at risk for developing infection. CERAMENT|G and CERAMENT™ V are available in the EU.

BONESUPPORT AB was founded in 1999 by Prof. Lars Lidgren, an internationally respected scientist who has been the President of various musculoskeletal societies. BONESUPPORT’s mission is to bring people with bone and joint diseases back to an active life. The company is based in Lund, Sweden.

bonesupport.com

BONESUPPORT™ and CERAMENT are registered trademarks.

Contact Information

BONESUPPORT AB

Richard Davies

info@bonesupport.com

+46 (0)46 286 53 24

 

Citigate Dewe Rogerson

David Dible, Mark Swallow, Marine Perrier

bonesupport@citigatedr.co.uk

+44 (0)20 7638 9571

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Press release PDF (122.29 KB)

Lennart Johansson to join BONESUPPORT™ Board of Directors

28th April

Lennart Johansson to join BONESUPPORT™ Board of Directors

Lund, Sweden, 28th April, 2017 – BONESUPPORT AB, an emerging leader in innovative injectable bioceramic bone scaffolds to treat bone voids caused by trauma, infection, disease or related surgery, announces the election of Lennart Johansson to its Board of Directors.

Mr Johansson has been a Senior Advisor at Patricia Industries AB since 2015, and was previously Managing Director (Business Development, Operating and Financial Investments) at Investor AB (2006-2015). Before that, he was Partner and Chief Executive Officer of Emerging Technologies ET AB. He is currently Board Member of Swedish Orphan Biovitrum AB and Hi3G Access AB; Deputy Board Member of Mölnlycke Health Care AB; and Chairman of Vectura AB. Mr Johansson holds an MBA from the Stockholm School of Economics (1980).

Håkan Björklund, Chairman of BONESUPPORT, said: “We are pleased to welcome Lennart to the BONESUPPORT Board. This is an exciting period for the Company and we are confident that Lennart’s experience will be a valuable asset assisting us to achieve our goals.”

Mr Johansson added: “I very much look forward to working with the BONESUPPORT management team and Board to help capitalize on the Company’s potential to become a global leader in the management and treatment of bone disease via its unique CERAMENTⓇ platform.”

Ends

Notes to Editor

 

About BONESUPPORT™

BONESUPPORT AB has developed CERAMENT™ as an innovative range of radiopaque injectable osteoconductive bioceramic products that have a proven ability to heal defects by remodeling to host bone in six to twelve months. Our products are effective in treating patients with fractures and bone voids caused by trauma, infection, disease or related surgery. Our lead product, CERAMENT™|BONE VOID FILLER (BVF) addresses important issues facing health care providers, such as avoiding hospital readmissions and revision surgery that result from failed bone healing and infection caused by residual bone voids. CERAMENT|BVF is commercially available in the U.S., EU, S.E. Asia and the Middle East.

CERAMENT's distinctive properties as a drug eluting material have been validated in clinical practice by CERAMENT™|G and CERAMENT™ V, the first CE-marked injectable antibiotic eluting bone graft substitutes. These products provide local sustained delivery of gentamicin and vancomycin, respectively. The local delivery feature enables an initial high concentration of antibiotics to the bone defect and then a longer sustainable dose above the minimal inhibitory concentration (MIC) to protect bone healing and promote bone remodeling.

CERAMENT|G and CERAMENT™ have demonstrated good results in patients with problematic bone infections including osteomyelitis. They are also used prophylactically in patients who are at risk for developing infection. CERAMENT|G and CERAMENT™ V are available in the EU.

BONESUPPORT AB was founded in 1999 by Prof. Lars Lidgren, an internationally respected scientist who has been the President of various musculoskeletal societies. BONESUPPORT’s mission is to bring people with bone and joint diseases back to an active life. The company is based in Lund, Sweden.

bonesupport.com

BONESUPPORT™ and CERAMENT are registered trademarks.

Contact Information

Björn Westberg

Chief Financial Officer

+46 (0) 46 286 53 24

info@bonesupport.com

Downloads

Press release PDF (140.07 KB)

BONESUPPORT™ appoints Michael Diefenbeck as Chief Medical Officer

11th April

BONESUPPORT™ appoints Michael Diefenbeck as Chief Medical Officer

Lund, Sweden, 11th April, 2017 – BONESUPPORT AB, an emerging leader in innovative injectable bioceramic bone scaffolds to treat bone voids caused by trauma, infection, disease or related surgery, announces the appointment of Michael Diefenbeck MD PhD as Chief Medical Officer.

Dr Diefenbeck founded Scientific Consulting in Orthopaedic Surgery in 2014 and has worked for BONESUPPORT on a range of clinical projects related to CERAMENT™ as an independent clinical advisor.

He is currently honorary consultant at Nuffield Orthopaedic Centre, Oxford University Hospitals. Dr. Diefenbeck studied medicine at Munich and was trained as an orthopaedic surgeon, specializing in trauma care and bone infections. He has 14 years’ clinical experience at different German hospitals (BG Unfallklinik Murnau, BG Kliniken Bergmannstrost Halle/Saale, University Hospital Jena and Schön Klinik Hamburg Eilbek). At University Hospital Jena he finished his PhD in 2011 and has since been involved in surgical education and training programs for students. He is author of 24 Pub-med listed research articles.

Dr Diefenbeck said: “I am excited to be joining BONESUPPORT at a particularly exciting time for the Company. I look forward to working with the BONESUPPORT team, to help shape the future development of the Company as it continues to develop and reinforce the clinical benefits that its CERAMENT based products deliver.”

Richard Davies, CEO of BONESUPPORT, said: “We are pleased to welcome Michael to the BONESUPPORT team. I have no doubt that with his extensive medical experience in the orthopaedics field and his knowledge of our CERAMENT platform he will be a real asset to BONESUPPORT as we look to grow our business and deliver value to all of our stakeholders.”

Dr Diefenbeck began his new role in April 2017 and reports to the CEO.

Ends

Notes to Editor

 

About BONESUPPORT™

BONESUPPORT AB has developed CERAMENT™ as an innovative range of radiopaque injectable osteoconductive bioceramic products that have a proven ability to heal defects by remodeling to host bone in six to twelve months. Our products are effective in treating patients with fractures and bone voids caused by trauma, infection, disease or related surgery. Our lead product, CERAMENT™|BONE VOID FILLER (BVF) addresses important issues facing health care providers, such as avoiding hospital readmissions and revision surgery that result from failed bone healing and infection caused by residual bone voids. CERAMENT|BVF is commercially available in the U.S., EU, S.E. Asia and the Middle East.

CERAMENT's distinctive properties as a drug eluting material have been validated in clinical practice by CERAMENT™|G and CERAMENT™ V, the first CE-marked injectable antibiotic eluting bone graft substitutes. These products provide local sustained delivery of gentamicin and vancomycin, respectively. The local delivery feature enables an initial high concentration of antibiotics to the bone defect and then a longer sustainable dose above the minimal inhibitory concentration (MIC) to protect bone healing and promote bone remodeling.

CERAMENT|G and CERAMENT™ have demonstrated good results in patients with problematic bone infections including osteomyelitis. They are also used prophylactically in patients who are at risk for developing infection. CERAMENT|G and CERAMENT™ V are available in the EU.

BONESUPPORT AB was founded in 1999 by Prof. Lars Lidgren, an internationally respected scientist who has been the President of various musculoskeletal societies. BONESUPPORT’s mission is to bring people with bone and joint diseases back to an active life. The company is based in Lund, Sweden.

bonesupport.com

BONESUPPORT™ is a registered trademark.

Contact Information

Citigate Dewe Rogerson

David Dible, Andrea Bici, Mark Swallow

+44 (0)20 7282 2949/1050/2948

Downloads

Press release PDF (108.08 KB)

BONESUPPORT™ Founder Lars Lidgren Receives the 2017 OREF Clinical Research Kappa Delta Award

16th March

BONESUPPORT™ Founder Lars Lidgren Receives the 2017 OREF Clinical Research Kappa Delta Award

LUND, Sweden, March 16, 2017 - BONESUPPORT AB, an emerging leader in innovative injectable bioceramic bone scaffolds to treat bone voids caused by trauma, infection, disease or related surgery, announces that its founder Lars Lidgren, is a member of a group of Swedish and US Knee and Hip surgeons from Lund and Gothenburg, Sweden, Boston and Rochester U.S. that has received the 2017 OREF Clinical Research Kappa Delta Award. The award was made for the group's outstanding research contribution leading to improved prosthetic survival and patient outcomes.

The OREF Clinical Research Kappa Delta recognizes outstanding clinical research related directly to musculoskeletal disease or injury. Henrik Malchau, MD, PhD, part of the Swedish and US group, will present the study "Arthroplasty Implant Registries Over The Past Five Decades: Development, Current and Future Impact" The award will be given at the AAOS meeting, San Diego, California on Thursday, March 16 at 11:00 am in the Ballroom 20.

Lars Lidgren, M.D., Ph.D. Hon. Member AAOS., founder of BONESUPPORT, said: "I'm delighted that clinical research on joint replacements, one of the most common surgical procedures today, has gained this very prestigious award. I am confident that our long term research based on arthroplasty registries will continue to help shape the development of new innovative technologies to provide patients with improved orthopaedic outcomes."

Ends

Notes to Editor

 

About BONESUPPORT™

BONESUPPORT AB has developed CERAMENT™ as an innovative range of radiopaque injectable osteoconductive bioceramic products that have a proven ability to heal defects by remodeling to host bone in six to twelve months. Our products are effective in treating patients with fractures and bone voids caused by trauma, infection, disease or related surgery. Our lead product, CERAMENT™|BONE VOID FILLER (BVF) addresses important issues facing health care providers, such as avoiding hospital readmissions and revision surgery that result from failed bone healing and infection caused by residual bone voids. CERAMENT|BVF is commercially available in the U.S., EU, S.E. Asia and the Middle East.

CERAMENT's distinctive properties as a drug eluting material have been validated in clinical practice by CERAMENT™|G and CERAMENT™ V, the first CE-marked injectable antibiotic eluting bone graft substitutes. These products provide local sustained delivery of gentamicin and vancomycin, respectively. The local delivery feature enables an initial high concentration of antibiotics to the bone defect and then a longer sustainable dose above the minimal inhibitory concentration (MIC) to protect bone healing and promote bone remodeling.

CERAMENT|G and CERAMENT™ have demonstrated good results in patients with problematic bone infections including osteomyelitis. They are also used prophylactically in patients who are at risk for developing infection. CERAMENT|G and CERAMENT™ V are available in the EU.

BONESUPPORT AB was founded in 1999 by Prof. Lars Lidgren, an internationally respected scientist who has been the President of various musculoskeletal societies. BONESUPPORT’s mission is to bring people with bone and joint diseases back to an active life. The company is based in Lund, Sweden.

bonesupport.com

BONESUPPORT™ is a registered trademark.

Contact Information

Citigate Dewe Rogerson

David Dible, Andrea Bici, Mark Swallow

+44 (0)20 7282 2949/1050/2948

Downloads

Press release PDF (119.26 KB)

BONESUPPORT™ Extends U.S. Distribution Agreement for CERAMENT®|BONE VOID FILLER

14th March

BONESUPPORT™ Extends U.S. Distribution Agreement for CERAMENT®|BONE VOID FILLER

Lund, Sweden, 14 March, 2017 – BONESUPPORT AB, an emerging leader in innovative injectable bioceramic bone scaffolds to treat bone voids caused by trauma, infection, disease or related surgery, announces that it has extended the term of its U.S. distribution agreement with Zimmer Biomet. Under the agreement, Zimmer Biomet will continue to have exclusive rights for BONESUPPORT’s proprietary CERAMENT BONE VOID FILLER product line for Orthopedics, Trauma and Foot and Ankle indications in the United States.

“We are extremely pleased to extend our distribution agreement with Zimmer Biomet,” said Richard Davies, CEO of BONESUPPORT™. “The partnership has been very successful and has resulted in the current rapid growth of our flagship product, CERAMENT in the world’s largest bone graft substitute market. This rapid growth is building an important platform from which we can launch product extensions into the US.” 

In addition to commercialization of CERAMENT BONE VOID FILLER in the U.S. market, BONESUPPORT is currently enrolling patients into the FORTIFY Clinical Study, an FDA approved IDE randomized control pivotal study for the Company’s antibiotic eluting product CERAMENT G. CERAMENT G is currently approved and commercialized in the EU and other markets outside the United States.

Ends

Notes to Editor

 

About BONESUPPORT™

BONESUPPORT AB has developed CERAMENT™ as an innovative range of radiopaque injectable osteoconductive bioceramic products that have a proven ability to heal defects by remodeling to host bone in six to twelve months. Our products are effective in treating patients with fractures and bone voids caused by trauma, infection, disease or related surgery. Our lead product, CERAMENT™|BONE VOID FILLER (BVF) addresses important issues facing health care providers, such as avoiding hospital readmissions and revision surgery that result from failed bone healing and infection caused by residual bone voids. CERAMENT|BVF is commercially available in the U.S., EU, S.E. Asia and the Middle East.

CERAMENT's distinctive properties as a drug eluting material have been validated in clinical practice by CERAMENT™|G and CERAMENT™ V, the first CE-marked injectable antibiotic eluting bone graft substitutes. These products provide local sustained delivery of gentamicin and vancomycin, respectively. The local delivery feature enables an initial high concentration of antibiotics to the bone defect and then a longer sustainable dose above the minimal inhibitory concentration (MIC) to protect bone healing and promote bone remodeling.

CERAMENT|G and CERAMENT™ have demonstrated good results in patients with problematic bone infections including osteomyelitis. They are also used prophylactically in patients who are at risk for developing infection. CERAMENT|G and CERAMENT™ V are available in the EU.

BONESUPPORT AB was founded in 1999 by Prof. Lars Lidgren, an internationally respected scientist who has been the President of various musculoskeletal societies. BONESUPPORT’s mission is to bring people with bone and joint diseases back to an active life. The company is based in Lund, Sweden.

bonesupport.com

BONESUPPORT™ is a registered trademark.

Contact Information

Citigate Dewe Rogerson

David Dible, Andrea Bici, Mark Swallow

+44 (0)20 7282 2949/1050/2948

Downloads

Press release PDF (107.83 KB)

BONESUPPORT CEO to present at the Medtech Showcase 2017, in conjunction with the 9th Annual Biotech Showcase™

6th January

BONESUPPORT CEO to present at the Medtech Showcase 2017, in conjunction with the 9th Annual Biotech Showcase™

Lund, Sweden, 6 January, 2017 – BONESUPPORT AB, an emerging leader in innovative injectable bioceramic bone scaffolds to treat bone voids caused by trauma, infection, disease or related surgery, announces that its CEO Richard Davies will present an overview of the company at 11:00hrs PST on Wednesday 11 January at the Medtech Showcase in San Francisco, US.

Medtech Showcase takes place in conjunction with the 9th Annual Biotech Showcase™.

During his presentation, Mr. Davies will introduce and describe commercial and development plans for BONESUPPORT’s portfolio of proprietary CERAMENT™ products, which offer a single-stage procedure to fill bone voids effectively, and to reduce and manage infection; a compelling clinical value proposition for hospitals and payers to help reduce readmissions and hospital length of stay. 

Ends

Notes to Editor

 

About BONESUPPORT™

BONESUPPORT AB has developed CERAMENT™ as an innovative range of radiopaque injectable osteoconductive bioceramic products that have a proven ability to heal defects by remodeling to host bone in six to twelve months. Our products are effective in treating patients with fractures and bone voids caused by trauma, infection, disease or related surgery. Our lead product, CERAMENT™|BONE VOID FILLER (BVF) addresses important issues facing health care providers, such as avoiding hospital readmissions and revision surgery that result from failed bone healing and infection caused by residual bone voids. CERAMENT|BVF is commercially available in the U.S., EU, S.E. Asia and the Middle East.

CERAMENT's distinctive properties as a drug eluting material have been validated in clinical practice by CERAMENT™|G and CERAMENT™ V, the first CE-marked injectable antibiotic eluting bone graft substitutes. These products provide local sustained delivery of gentamicin and vancomycin, respectively. The local delivery feature enables an initial high concentration of antibiotics to the bone defect and then a longer sustainable dose above the minimal inhibitory concentration (MIC) to protect bone healing and promote bone remodeling.

CERAMENT|G and CERAMENT™ have demonstrated good results in patients with problematic bone infections including osteomyelitis. They are also used prophylactically in patients who are at risk for developing infection. CERAMENT|G and CERAMENT™ V are available in the EU.

BONESUPPORT AB was founded in 1999 by Prof. Lars Lidgren, an internationally respected scientist who has been the President of various musculoskeletal societies. BONESUPPORT’s mission is to bring people with bone and joint diseases back to an active life. The company is based in Lund, Sweden.

bonesupport.com

BONESUPPORT™ is a registered trademark.

Contact Information

Citigate Dewe Rogerson

David Dible, Andrea Bici, Mark Swallow

+44 (0)20 7282 2949/1050/2948

Downloads

Press release PDF (105.84 KB)

Björn Westberg to join BONESUPPORT™ as Chief Financial Officer

21st December

Björn Westberg to join BONESUPPORT™ as Chief Financial Officer

Lund, Sweden, 21 December 2016 – BONESUPPORT AB, an emerging leader in innovative injectable bioceramic bone scaffolds to treat bone voids caused by trauma, infection, disease or related surgery, announces that Björn Westberg is to join the Company as Chief Financial Officer and Director in early 2017.

Mr Westberg brings nearly 30 years’ finance and management experience to BONESUPPORT. He joins from Recipharm AB (publ) - one of the largest pharmaceutical contract manufacturers in the world - where he has been CFO since 2007. Prior to this he was CFO of the listed (Nasdaq Stockholm) software company Jeeves (2001-2007), and before that he held senior roles at AstraZeneca, among those Finance Director ISMO Northern Europe and Controller in Astra Japan. 

Mr Westberg replaces Offer Nonhoff, who is to leave after four-and-a-half-years with the company.

Richard Davies, CEO of BONESUPPORT, said: “I am very pleased to welcome Björn to the BONESUPPORT team. He brings with him a wealth of finance and management experience that I am confident will be crucial to the future growth and development of the company. With our recent strengthening of the Board, with the appointment of Dr. Hakan Björklund as Chairman and Tone Kvåle as a Non-executive Director, and Patrick O’Donnell joining to drive our rapidly growing North American business, we are building a first rate team with the experience and talent that will help us realise the significant potential of our CERAMENT™ platform.

“I would also like to thank Offer for his dedication to BONESUPPORT over the years and wish him all the very best in the future.”

Mr Westberg adds: “I look forward to joining BONESUPPORT, where I am confident that my experience will be important as they grow the sales of CERAMENT™ BVF, CERAMENT™ G and CERAMENT™ V and invest in clinical data that will further differentiate these products in the minds of surgeons and payers. BONESUPPORT also has an exciting product pipeline, based on the unique drug eluting properties of its proprietary CERAMENT™ platform which will be targeting the treatment of a broader range of bone diseases. Given these strengths and the quality of the BONESUPPORT team I am confident that the Company can achieve its strategic goals.” 

Ends

Notes to Editor

 

About BONESUPPORT™

BONESUPPORT AB has developed CERAMENT™ as an innovative range of radiopaque injectable osteoconductive bioceramic products that have a proven ability to heal defects by remodeling to host bone in six to twelve months. Our products are effective in treating patients with fractures and bone voids caused by trauma, infection, disease or related surgery. Our lead product, CERAMENT™|BONE VOID FILLER (BVF) addresses important issues facing health care providers, such as avoiding hospital readmissions and revision surgery that result from failed bone healing and infection caused by residual bone voids. CERAMENT|BVF is commercially available in the U.S., EU, S.E. Asia and the Middle East.

CERAMENT's distinctive properties as a drug eluting material have been validated in clinical practice by CERAMENT™|G and CERAMENT™ V, the first CE-marked injectable antibiotic eluting bone graft substitutes. These products provide local sustained delivery of gentamicin and vancomycin, respectively. The local delivery feature enables an initial high concentration of antibiotics to the bone defect and then a longer sustainable dose above the minimal inhibitory concentration (MIC) to protect bone healing and promote bone remodeling.

CERAMENT|G and CERAMENT™ have demonstrated good results in patients with problematic bone infections including osteomyelitis. They are also used prophylactically in patients who are at risk for developing infection. CERAMENT|G and CERAMENT™ V are available in the EU.

BONESUPPORT AB was founded in 1999 by Prof. Lars Lidgren, an internationally respected scientist who has been the President of various musculoskeletal societies. BONESUPPORT’s mission is to bring people with bone and joint diseases back to an active life. The company is based in Lund, Sweden.

bonesupport.com

BONESUPPORT™ is a registered trademark.

Contact Information

Citigate Dewe Rogerson

David Dible, Andrea Bici, Mark Swallow

+44 (0)20 7282 2949/1050/2948

Downloads

Press release PDF (108.42 KB)

BONESUPPORT confirms election of Dr. Håkan Björklund as Chairman of the Board

16th December

BONESUPPORT confirms election of Dr. Håkan Björklund as Chairman of the Board

Tone Kvåle, CFO of Nordic Nanovector, elected as a new Board Member

Lund, Sweden, 16 December 2016 – BONESUPPORT AB, an emerging leader in innovative injectable bioceramic bone scaffolds to treat bone voids caused by trauma, infection, disease or related surgery, announces, that Dr. Håkan Björklund has been confirmed as Chairman and that  Ms. Tone Kvåle has been elected as a  new Board Member. The appointments were made at an EGM held on 15 December 2016.

Dr. Björklund is Partner of Tellacq AB, a private investment firm. He joined the BONESUPPORT Board in September 2016 in conjunction with the Company’s $37 million (SEK 315 million) financing, which was led by Tellacq. Dr. Björklund has a long and successful track record in the healthcare industry, including as the former CEO of Nycomed, which he grew from a small Scandinavian company into a global business before its acquisition by Takeda in 2011. He is currently chairman of the board of Swedish Orphan Biovitrum AB and an Industry Executive at Avista Capital Partners.

Tone Kvåle joins as a Board Member and Head of the Audit Committee. She is currently Chief Financial Officer of Nordic Nanovector, an Oslo-listed biopharmaceutical company, and has more than 20 years’ biotech industry experience. Prior to joining Nordic Nanovector, she was CFO of NorDiag, Kavli Holding and Dynal Biotech, and has held senior management positions at Invitrogen, Life Technologies and ThermoFisher (US). Ms. Kvåle has a diploma in Finance & Administration from Harstad University College.

Richard Davies, CEO of BONESUPPORT, said: “I am extremely happy that Håkan has been elected Chairman and that Tone will be joining the Board. This is an exciting period for BONESUPPORT following our recent $37 million (SEK 315 million) financing. We are now focused on building further additional shareholder value by growing  sales of our current CERAMENT™ products, generating further data highlighting the clinical and health economic benefits these products deliver and progressing our pipeline. I am confident that Håkan’s and Tone’s experience will be valuable in helping us achieve our strategic goals.”

Dr. Björklund said: “I look forward to working with the management team and the Board to deliver BONESUPPORT’s potential to become a global leader in the management and treatment of bone disease based on the unique properties of its CERAMENT™ platform.”

Ends

Notes to Editor

 

About BONESUPPORT™

BONESUPPORT AB has developed CERAMENT™ as an innovative range of radiopaque injectable osteoconductive bioceramic products that have a proven ability to heal defects by remodeling to host bone in six to twelve months. Our products are effective in treating patients with fractures and bone voids caused by trauma, infection, disease or related surgery. Our lead product, CERAMENT™|BONE VOID FILLER (BVF) addresses important issues facing health care providers, such as avoiding hospital readmissions and revision surgery that result from failed bone healing and infection caused by residual bone voids. CERAMENT|BVF is commercially available in the U.S., EU, S.E. Asia and the Middle East.

CERAMENT's distinctive properties as a drug eluting material have been validated in clinical practice by CERAMENT™|G and CERAMENT™ V, the first CE-marked injectable antibiotic eluting bone graft substitutes. These products provide local sustained delivery of gentamicin and vancomycin, respectively. The local delivery feature enables an initial high concentration of antibiotics to the bone defect and then a longer sustainable dose above the minimal inhibitory concentration (MIC) to protect bone healing and promote bone remodeling.

CERAMENT|G and CERAMENT™ have demonstrated good results in patients with problematic bone infections including osteomyelitis. They are also used prophylactically in patients who are at risk for developing infection. CERAMENT|G and CERAMENT™ V are available in the EU.

BONESUPPORT AB was founded in 1999 by Prof. Lars Lidgren, an internationally respected scientist who has been the President of various musculoskeletal societies. BONESUPPORT’s mission is to bring people with bone and joint diseases back to an active life. The company is based in Lund, Sweden.

bonesupport.com

BONESUPPORT™ is a registered trademark.

Contact Information

Citigate Dewe Rogerson

David Dible, Andrea Bici, Mark Swallow

+44 (0)20 7282 2949/1050/2948

Downloads

Press release PDF (109.75 KB)

Richard Davies Wins “Best CEO in the Biomaterials Industry” Award from European CEO Magazine

13th December

Richard Davies Wins “Best CEO in the Biomaterials Industry” Award from European CEO Magazine

Lund, Sweden, 13 December, 2016 – BONESUPPORT AB, an emerging leader in innovative injectable bioceramic bone scaffolds to treat bone voids caused by trauma, infection, disease or related surgery, is pleased to announce that its CEO Richard Davies has won the “Best CEO in the Biomaterials Industry” award. The award was presented by European CEO Magazine based on Mr. Davies’ track record at the forefront of major new healthcare trends and the continuing success of BONESUPPORT™ under his leadership.

Mr. Davies became CEO of BONESUPPORT in January 2016, following nearly four years spent at Hospira, where he served as Chief Commercial Officer. While at Hospira, he drove growth, globalization and modernization across the business. Hospira was acquired by Pfizer at the end of 2015. Prior to Hospira, Mr. Davies spent nine years in increasingly senior leadership positions at Amgen in Europe, Australia and the U.S. His roles included leadership of the U.S. Inflammation sales group, which commercialized Enbrel® (etanercept), the most prescribed biologic medicine in the U.S. at that time. Mr. Davies began his career at Eli Lilly, spending 13 years in increasingly senior positions.

Richard Davies, CEO of BONESUPPORT, said: “I am very humbled to have been given this award. I firmly believe that BONESUPPORT has an exciting future based on the significant potential of its unique CERAMENT™ platform. This platform is truly innovative and enables surgeons to improve patient outcomes across a range of orthopaedic indications, enabling a single stage surgical procedure for osteomyelitis, reduce length of stay in hospital and lower the cost of care. These benefits are based on the platform’s important clinical features including its ability to rapidly remodel to host bone in six to 12 months, as well as being a carrier for therapeutics that enhance the bone healing process.”

BONESUPPORT recently raised $37 million (SEK 327 million) to support the execution of its strategy to deliver significant shareholder value, focused on:

- Driving the sales of CERAMENT™ BONE VOID FILLER, CERAMENT™ G and CERAMENT™ V (with the antibiotics gentamicin and vancomycin respectively)

- Generating further clinical data to highlight the compelling benefits that the current CERAMENT™ products deliver

- Conduct the FORTIFY study to support a planned PMA filing in the US for CERAMENT™ G

- Building the Company’s product pipeline by capitalizing on the unique drug-eluting properties of its injectable bioceramic platform 

BONESUPPORT believes that the attractive properties of its CERAMENT™ platform will allow it to develop products that are both osteoconductive and osteoinductive for use managing a range of bone diseases where enhanced bone growth is needed to improve treatment outcomes.

Ends

Notes to Editor

 

About BONESUPPORT™

BONESUPPORT AB has developed CERAMENT™ as an innovative range of radiopaque injectable osteoconductive bioceramic products that have a proven ability to heal defects by remodeling to host bone in six to twelve months. Our products are effective in treating patients with fractures and bone voids caused by trauma, infection, disease or related surgery. Our lead product, CERAMENT™|BONE VOID FILLER (BVF) addresses important issues facing health care providers, such as avoiding hospital readmissions and revision surgery that result from failed bone healing and infection caused by residual bone voids. CERAMENT|BVF is commercially available in the U.S., EU, S.E. Asia and the Middle East.

CERAMENT's distinctive properties as a drug eluting material have been validated in clinical practice by CERAMENT™|G and CERAMENT™ V, the first CE-marked injectable antibiotic eluting bone graft substitutes. These products provide local sustained delivery of gentamicin and vancomycin, respectively. The local delivery feature enables an initial high concentration of antibiotics to the bone defect and then a longer sustainable dose above the minimal inhibitory concentration (MIC) to protect bone healing and promote bone remodeling.

CERAMENT|G and CERAMENT™ have demonstrated good results in patients with problematic bone infections including osteomyelitis. They are also used prophylactically in patients who are at risk for developing infection. CERAMENT|G and CERAMENT™ V are available in the EU.

BONESUPPORT AB was founded in 1999 by Prof. Lars Lidgren, an internationally respected scientist who has been the President of various musculoskeletal societies. BONESUPPORT’s mission is to bring people with bone and joint diseases back to an active life. The company is based in Lund, Sweden.

bonesupport.com

BONESUPPORT™ is a registered trademark.

Contact Information

Citigate Dewe Rogerson

David Dible, Andrea Bici, Mark Swallow

+44 (0)20 7282 2949/1050/2948

Downloads

Press release PDF (115.31 KB)

BONESUPPORT™ Announces Key Corporate Appointment To Drive Growth in North America

7th November

BONESUPPORT™ Announces Key Corporate Appointment To Drive Growth in North America

Lund, Sweden, 7 November, 2016 – BONESUPPORT AB, an emerging leader in innovative injectable bioceramic bone graft substitutes to treat bone voids caused by trauma, infection, disease or related surgery, is pleased to announce the appointment of Patrick O’Donnell as General Manager and Executive Vice President, North American Commercialization to its leadership team.  Mr O’Donnell will lead the relationship with the company’s partner, Zimmer Biomet, to drive revenue growth of BONESUPPORT’s CERAMENT™|BONE VOID FILLER (BVF). He will also set the strategy for the introduction of CERAMENT™|G, a novel gentamicin eluting bone graft substitute, to the U.S. market pending a positive outcome of the planned FORTIFY PMA trial and subject to FDA approval.

Mr O’Donnell joins BONESUPPORT after serving as CEO of three companies focused on innovative orthopaedic regenerative technologies.  Following his role as CEO of Histogenics Corporation, he was most recently the Co-Founder and CEO of ProteoThera Inc., based in Cambridge, MA.  His experience includes being head of Global Marketing of Confluent Surgical, where he launched and built the DuraSeal™ brand of surgical dural sealant products, currently owned by Integra LifeSciences. In addition, he spent 13 years in sales, sales management and marketing in orthobiologics and medical devices at Johnson & Johnson’s DePuy Spine Division.

Mr O’Donnell said: “I am very pleased about the opportunity and quite fortunate to be joining BONESUPPORT at a very important and exciting tipping point stage for the Company. I look forward to working with the BONESUPPORT team to optimize the significant potential of CERAMENT|BVF and in time CERAMENT|G in North America.”

Richard Davies, CEO of BONESUPPORT, said: “We are excited to welcome Patrick to the BONESUPPORT team, particularly after completing the recent financing, which will be crucial to executing our strategy. Patrick brings with him a great breadth of experience ranging from start-ups to small and large companies. He has an in-depth of knowledge of the orthobiologics space and appreciation of the significant potential of our unique CERAMENT™ drug eluting osteoconductive bioceramic platform to develop a pipeline of novel products for a broad range of bone diseases. The clinical value proposition of our products is expected to become increasingly relevant to the U.S. healthcare market which is undergoing a sea change to value based care.” 

Ends

Notes to Editor

 

About BONESUPPORT™

BONESUPPORT AB has developed CERAMENT™ as an innovative range of radiopaque injectable osteoconductive bioceramic products that have a proven ability to heal defects by remodeling to host bone in six to twelve months. Our products are effective in treating patients with fractures and bone voids caused by trauma, infection, disease or related surgery. Our lead product, CERAMENT™|BONE VOID FILLER (BVF) addresses important issues facing health care providers, such as avoiding hospital readmissions and revision surgery that result from failed bone healing and infection caused by residual bone voids. CERAMENT|BVF is commercially available in the U.S., EU, S.E. Asia and the Middle East.

CERAMENT's distinctive properties as a drug eluting material have been validated in clinical practice by CERAMENT™|G and CERAMENT™ V, the first CE-marked injectable antibiotic eluting bone graft substitutes. These products provide local sustained delivery of gentamicin and vancomycin, respectively. The local delivery feature enables an initial high concentration of antibiotics to the bone defect and then a longer sustainable dose above the minimal inhibitory concentration (MIC) to protect bone healing and promote bone remodeling.

CERAMENT|G and CERAMENT™ have demonstrated good results in patients with problematic bone infections including osteomyelitis. They are also used prophylactically in patients who are at risk for developing infection. CERAMENT|G and CERAMENT™ V are available in the EU.

BONESUPPORT AB was founded in 1999 by Prof. Lars Lidgren, an internationally respected scientist who has been the President of various musculoskeletal societies. BONESUPPORT’s mission is to bring people with bone and joint diseases back to an active life. The company is based in Lund, Sweden.

bonesupport.com

BONESUPPORT™ is a registered trademark.

Contact Information

Citigate Dewe Rogerson

David Dible, Andrea Bici, Mark Swallow

+44 (0)20 7282 2949/1050/2948

Downloads

Press release PDF (109.48 KB)

BONESUPPORT™ Raises $37 Million (SEK 327 million) to Drive Product Sales and Deliver Further Value From CERAMENT® Injectable Drug Eluting Bioceramic Platform

27th October

BONESUPPORT™ Raises $37 Million (SEK 327 million) to Drive Product Sales and Deliver Further Value From CERAMENT® Injectable Drug Eluting Bioceramic Platform

- Dr. Håkan Björklund of Tellacq AB, former CEO of Nycomed, becomes Chairman-Elect   

- CERAMENT™ BVF, CERAMENT™ G AND CERAMENT™ V continue to increase sales rapidly driven by a growing body of compelling clinical data

Lund, Sweden, 27 October, 2016 - BONESUPPORT AB an emerging leader in innovative injectable bioceramic bone scaffolds to treat bone voids caused by trauma, infection, disease or related surgery, announces that it has raised $37 million (SEK 327 million) in a combination of equity and debt finance. These new funds will be used to deliver further value from its unique CERAMENT™ platform. The oversubscribed equity financing was led by Tellacq AB and was supported by the Company's current major shareholders, including HealthCap, Lundbeckfond Ventures, Industrifonden, AP3 (The Third Swedish National Pension Fund) and Carl Westin. The debt finance was provided by Kreos Capital.

Dr. Håkan Björklund of Tellacq AB will be joining the BONESUPPORT Board as Chairman in conjunction with the fund raising, subject to shareholder approval. Dr. Björklund has a long and successful track record in the healthcare industry, including as the former CEO of Nycomed, which he grew from a small Scandinavian company into a global business before its acquisition by Takeda in 2011. He is currently chairman of the board of Swedish Orphan Biovitrum AB and an Industry Executive at Avista Capital Partners.

Richard Davies, CEO of BONESUPPORT said, "I am delighted that we have been able to complete this new financing to help us to execute our strategy to deliver the significant potential of our unique CERAMENT™ drug eluting osteoconductive/osteoinductive bioceramic platform. I am also pleased that the equity element reflects the significant progress that we have made during the course of 2016. With our sales on a strong growth trajectory, an increasing body of compelling clinical data and a drug eluting platform that will allow us to develop a pipeline of novel products to treat a broad range of bone diseases, BONESUPPORT can look to the future with great confidence."

"We are delighted to welcome Håkan Björklund to the board at this exciting time for the company and look forward to benefiting from his extensive experience in the years ahead. I would also like to take this opportunity to thank the departing chairman Dr. Örn Stuge for his significant contribution to BONESUPPORT over many years" says Björn Odlander, Managing Partner at HealthCap and board member.

Håkan Björklund, said: "Our decision to invest in BONESUPPORT was driven by the important progress that has been made over recent years. The CERAMENT™ drug eluting platform offers multiple opportunities to generate significant value by providing much needed and cost-efficient treatment options for patients with a broad range of bone diseases. I look forward to working with the management team and the Board to deliver BONESUPPORT's potential to become a global leader in the management and treatment of bone disease." 

The new funds will be used to support the execution of BONESUPPORT's strategy to deliver significant shareholder value, focused on:

- Driving the sales of CERAMENT™ BVF, CERAMENT™ G and CERAMENT™ V in existing and new markets

- Generating further clinical data to highlight the compelling benefits that the current CERAMENT™ products deliver and to conduct the FORTIFY study to support a planned PMA filing in the US for CERAMENT™ G

- Building the Company's product pipeline by capitalizing on the unique drug eluting properties of its injectable osteoconductive/osteoinductive bioceramic platform.

In the first half of 2016, BONESUPPORT's overall sales have continued to grow rapidly driven by the European success of CERAMENT™ G and CERAMENT™ V, the first CE-marked injectable antibiotic eluting bone graft substitutes. These products are used for the management of problematic bone infections including osteomyelitis and prophylactically in patients who are at risk for developing infection. Sales of CERAMENT™ BVF have also shown good growth as the product has continued to gain traction in the US where it is marketed by BONESUPPORT's partner Zimmer Biomet.

BONESUPPORT is also continuing to generate the clinical data needed to drive the adoption of its products. A recent paper in The Bone and Joint Journal[1] provided follow up data from the first 100 patients in a prospective study evaluating CERAMENT™ G for dead space (void) management in patients with chronic osteomyelitis (bone infection) using a single stage surgical procedure. These data showed that this approach, augmented by the use of CERAMENT™ G, was highly effective, delivering a 96% prevention of infection recurrence rate, a 3.0% fracture rate and a total wound leakage rate of 6.0%. This represents a significant improvement in both the infection recurrence and fracture rates when compared to published results evaluating alternative bone graft substitutes that deliver antibiotics locally.

The Company has also recently received approval from the US Food and Drug Administration (FDA) to begin an IDE (Investigational Device Exemption) study with CERAMENT™ G. The FORTIFY study, a randomized multicenter controlled trial, which will evaluate the safety and efficacy of CERAMENT™ G as part of surgical repair of open diaphyseal tibial fractures. The first patient is expected to be recruited into this prophylactic study before the end of 2016.

BONESUPPORT will also use the funds to develop its product pipeline. The Company believes that the attractive properties of its CERAMENT™ platform will allow it to develop products that will deliver a broad range of drugs to the bone to manage indications including osteoporosis, cancer and pain.

References

1. McNally et al, The Bone and Joint Journal, 2016, Vol. 98-B, No. 9, p1289-9

2. Raina, D. et al. A Biphasic Calcium Sulfate Hydroxapatite Carrier Bone Morphogenic Protein -2 and Zoledronic Acid Generates Bone (2016) Nature Scientific Reports

 

Ends

Notes to Editor

 

About BONESUPPORT™

BONESUPPORT AB has developed CERAMENT™ as an innovative range of radiopaque injectable osteoconductive bioceramic products that have a proven ability to heal defects by remodeling to host bone in six to twelve months. Our products are effective in treating patients with fractures and bone voids caused by trauma, infection, disease or related surgery. Our lead product, CERAMENT™|BONE VOID FILLER (BVF) addresses important issues facing health care providers, such as avoiding hospital readmissions and revision surgery that result from failed bone healing and infection caused by residual bone voids. CERAMENT|BVF is commercially available in the U.S., EU, S.E. Asia and the Middle East.

CERAMENT's distinctive properties as a drug eluting material have been validated in clinical practice by CERAMENT™|G and CERAMENT™ V, the first CE-marked injectable antibiotic eluting bone graft substitutes. These products provide local sustained delivery of gentamicin and vancomycin, respectively. The local delivery feature enables an initial high concentration of antibiotics to the bone defect and then a longer sustainable dose above the minimal inhibitory concentration (MIC) to protect bone healing and promote bone remodeling.

CERAMENT|G and CERAMENT™ have demonstrated good results in patients with problematic bone infections including osteomyelitis. They are also used prophylactically in patients who are at risk for developing infection. CERAMENT|G and CERAMENT™ V are available in the EU.

BONESUPPORT AB was founded in 1999 by Prof. Lars Lidgren, an internationally respected scientist who has been the President of various musculoskeletal societies. BONESUPPORT’s mission is to bring people with bone and joint diseases back to an active life. The company is based in Lund, Sweden.

bonesupport.com

BONESUPPORT™ is a registered trademark.

Contact Information

Citigate Dewe Rogerson

David Dible, Andrea Bici, Mark Swallow

+44 (0)20 7282 2949/1050/2948

Downloads

Press release PDF (130.84 KB)

BONESUPPORT™‘s CERAMENT®|G Highly Effective Adjunct in the Single Stage Surgical Management of Chronic Osteomyelitis

1st September

BONESUPPORT™‘s CERAMENT®|G Highly Effective Adjunct in the Single Stage Surgical Management of Chronic Osteomyelitis

Single stage surgical procedure achieves 96% infection eradication rate

Lund, Sweden, 1 September 2016 – BONESUPPORT AB, an emerging leader in innovative injectable bioresorbable bone graft substitute products to treat bone voids caused by trauma, infection, disease or related surgery, today announced the publication of a paper in The Bone and Joint Journal: Single-stage treatment of chronic osteomyelitis with a new absorbable gentamicin-loaded, calcium sulphate/hydroxyapatite biocomposite - A prospective series of 100 cases. McNally et al, The Bone and Joint Journal, 2016, Vol. 98-B, No. 9, p1289-96.

The paper provides 12-34 month follow up data from the first 100 patients in a prospective study evaluating CERAMENT™ G for dead space (void) management in patients with chronic osteomyelitis (bone infection) using a single stage surgical procedure. These data showed that this approach, augmented by the use of CERAMENT™ G, was highly effective, delivering a 96% prevention of infection recurrence rate, a 3.0% fracture rate and a total wound leakage rate of 6.0%.  This is significantly lower than published results with alternative bone graft substitutes that deliver antibiotics locally.

These results highlight the essential properties of CERAMENT™ G in the management of chronic osteomyelitis. The very encouraging infection recurrence prevention rate is supported by CERAMENT™ G’s attractive local delivery properties, which enable it to provide an initial targeted ultra-high concentration of gentamicin into the bone defect and then a longer sustainable dose above the minimal inhibitory concentration (MIC) of the bacteria that initially caused the osteomyelitis. This unique antibiotic-eluting profile helps protect the bone healing process and promote bone remodeling.

The bone healing and bone remodeling properties of CERAMENT™ G, when combined with gentamicin, make it an ideal solution for dead space management in patients with chronic osteomyelitis. It is able to fill the void completely due to its injectability and to provide initial structural stability due to its self-setting properties.

The use of CERAMENT™ G to deliver gentamicin locally could play an important role in improving antibiotic stewardship in hospitals by increasing compliance and reducing the need for patients with chronic osteomyelitis to receive long term systemic antibiotics.

Mr Martin McNally, Consultant Bone Infection and Limb Reconstruction Surgeon at Oxford University Hospitals (Oxford, UK) and lead author of the paper said, “The results that we have achieved with the single stage surgical procedure using CERAMENT™ G for the dead space management of patients with chronic osteomyelitis are a significant improvement on past experience. These results reflect CERAMENT™ G’s unique local antibiotic delivery profile and its attractive bone remodeling capabilities. We are increasingly using CERAMENT™ G in the treatment of patients with chronic osteomyelitis and infected fractures. It allows a more patient-friendly treatment, preventing repeated operations and recurrent infections. We expect it to become the mainstay of our dead space management, given the major clinical and health economic benefits that it supports.”

The paper covers the first 100 patients in a prospective cohort study utilising CERAMENT™ G for dead space management in a single stage surgical procedure for chronic osteomyelitis. The mean duration of chronic osteomyelitis in this patient group was 10.4 years (0.5 to 68 years). All surgeries were performed by two surgeons and were completed in a single operative session. All patients were given similar systemic antibiotic therapy and rehabilitation. Patients were followed up for at least 12 months (mean 19.5 months, range 12 -34 months) with infection recurrence, fracture rate and wound leakage rate as the primary outcome measure. The study showed that the single stage surgical procedure with CERAMENT™ G, was highly effective delivering a 96% infection recurrence prevention rate, a 3.0% fracture rate and a total wound leakage rate of 6.0%.

Richard Davies, CEO of BONESUPPORT said, “The results that have been published today highlight the clear clinical benefits with CERAMENT™ G’s ability to deliver sustained bactericidal levels of gentamicin locally to support the eradication of underlying infections in patients with chronic osteomyelitis. By using CERAMENT™ G in a single stage procedure to help patients with chronic osteomyelitis return to a normal life, we can deliver significant health economic benefits to payors who are struggling to contain the significant and growing costs of treating severely debilitating bone infection.”

Reference

1. McNally et al, The Bone and Joint Journal, 2016, Vol. 98-B, No. 9, p1289-96.

 

Ends

Notes to Editor

 

About BONESUPPORT™

BONESUPPORT AB has developed CERAMENT™ as an innovative range of radiopaque injectable osteoconductive bioceramic products that have a proven ability to heal defects by remodeling to host bone in six to twelve months. Our products are effective in treating patients with fractures and bone voids caused by trauma, infection, disease or related surgery. Our lead product, CERAMENT™|BONE VOID FILLER (BVF) addresses important issues facing health care providers, such as avoiding hospital readmissions and revision surgery that result from failed bone healing and infection caused by residual bone voids. CERAMENT|BVF is commercially available in the U.S., EU, S.E. Asia and the Middle East.

CERAMENT's distinctive properties as a drug eluting material have been validated in clinical practice by CERAMENT™|G and CERAMENT™ V, the first CE-marked injectable antibiotic eluting bone graft substitutes. These products provide local sustained delivery of gentamicin and vancomycin, respectively. The local delivery feature enables an initial high concentration of antibiotics to the bone defect and then a longer sustainable dose above the minimal inhibitory concentration (MIC) to protect bone healing and promote bone remodeling.

CERAMENT|G and CERAMENT™ have demonstrated good results in patients with problematic bone infections including osteomyelitis. They are also used prophylactically in patients who are at risk for developing infection. CERAMENT|G and CERAMENT™ V are available in the EU.

BONESUPPORT AB was founded in 1999 by Prof. Lars Lidgren, an internationally respected scientist who has been the President of various musculoskeletal societies. BONESUPPORT’s mission is to bring people with bone and joint diseases back to an active life. The company is based in Lund, Sweden.

bonesupport.com

BONESUPPORT™ is a registered trademark.

Contact Information

Citigate Dewe Rogerson

David Dible, Andrea Bici, Mark Swallow

+44 (0)20 7282 2949/1050/2948

Downloads

Press release PDF (118.83 KB)

BONESUPPORT™‘s CERAMENT®|G and CERAMENT® V to be Featured Extensively at the 35th Annual Meeting of the European Bone & Joint Infection Society (EBJIS) in Oxford, UK

30th August

BONESUPPORT™‘s CERAMENT®|G and CERAMENT® V to be Featured Extensively at the 35th Annual Meeting of the European Bone & Joint Infection Society (EBJIS) in Oxford, UK

Lund, Sweden, 30 August 2016 – BONESUPPORT AB, an emerging leader in innovative injectable bioceramic bone substitute products to treat bone voids caused by trauma, infection, disease or related surgery, today announced that presentations and posters covering research with its CERAMENT™ G and CERAMENT™ V will feature extensively at the upcoming 35th Annual Meeting of the European Bone & Joint Infection Society (EBJIS) taking place September 1-3 in Oxford, UK - which is a key congress for physicians and surgeons managing patients with bone infections. CERAMENT™ G and CERAMENT™ V are the only CE-marked injectable antibiotic eluting bone graft substitutes which provide local sustained delivery of gentamicin and vancomycin, respectively.

The EBJIS annual meeting will feature 25 abstracts highlighting research and clinical findings with CERAMENT™ G and CERAMENT™ V. This is a significant increase in the number of presentations and posters that were made at the 34th Annual EBJIS meeting reflecting the impressive clinical performance reported, the launch of CERAMENT™ V in 2016 and the growing interest in the only injectable antibiotic eluting bone graft substitutes that are available in Europe. Both CERAMENT™ G and CERAMENT™ V are able to deliver an initial high concentration of antibiotic to the bone defect and then a longer sustainable dose above the minimal inhibitory concentration (MIC) to promote and protect bone healing and remodeling.

Richard Davies, CEO of BONESUPPORT, said: “The broad range of research and clinical data on CERAMENT™ G and CERAMENT™ V being presented at this year’s EBJIS Annual meeting highlights the significant increase in interest in these novel injectable antibiotic eluting bone graft substitutes. The new data also underscores BONESUPPORT’s commitment to supporting high-quality research that will help improve the management of important bone diseases. We are confident that the growing body of clinical evidence in support of both CERAMENT™ G and CERAMENT™ V will allow them to be used increasingly in patients with problematic bone infections including osteomyelitis, as well as prophylactically in patients at risk for developing an infection.”

BONESUPPORT recently received approval from the US Food and Drug Administration (FDA) to begin the FORTIFY study, an IDE (Investigational Device Exemption) study, with CERAMENT™ G.  This study is a randomized multicenter controlled trial that will evaluate the safety and efficacy of CERAMENT™ G as part of surgical repair of open diaphyseal tibial fractures. The first patient is expected to be recruited into the FORTIFY study by the end of 2016. Data from the FORTIFY study will be an important component of BONESUPPORT’S planned PMA to gain US approval for CERAMENT™ G.

EBJIS is a European association of orthopedic surgeons, trauma surgeons, infection specialists and microbiologists. The aim of the Society is to promote the knowledge of all infections affecting the Musculoskeletal system (bone and joint infections) and to promote the prevention and treatment of these infections. The complete program of the EBJIS meeting is available at http://ebjis.org/.

Ends

Notes to Editor

 

About BONESUPPORT™

BONESUPPORT AB has developed CERAMENT™ as an innovative range of radiopaque injectable osteoconductive bioceramic products that have a proven ability to heal defects by remodeling to host bone in six to twelve months. Our products are effective in treating patients with fractures and bone voids caused by trauma, infection, disease or related surgery. Our lead product, CERAMENT™|BONE VOID FILLER (BVF) addresses important issues facing health care providers, such as avoiding hospital readmissions and revision surgery that result from failed bone healing and infection caused by residual bone voids. CERAMENT|BVF is commercially available in the U.S., EU, S.E. Asia and the Middle East.

CERAMENT's distinctive properties as a drug eluting material have been validated in clinical practice by CERAMENT™|G and CERAMENT™ V, the first CE-marked injectable antibiotic eluting bone graft substitutes. These products provide local sustained delivery of gentamicin and vancomycin, respectively. The local delivery feature enables an initial high concentration of antibiotics to the bone defect and then a longer sustainable dose above the minimal inhibitory concentration (MIC) to protect bone healing and promote bone remodeling.

CERAMENT|G and CERAMENT™ have demonstrated good results in patients with problematic bone infections including osteomyelitis. They are also used prophylactically in patients who are at risk for developing infection. CERAMENT|G and CERAMENT™ V are available in the EU.

BONESUPPORT AB was founded in 1999 by Prof. Lars Lidgren, an internationally respected scientist who has been the President of various musculoskeletal societies. BONESUPPORT’s mission is to bring people with bone and joint diseases back to an active life. The company is based in Lund, Sweden.

bonesupport.com

BONESUPPORT™ is a registered trademark.

Contact Information

Citigate Dewe Rogerson

David Dible, Andrea Bici, Mark Swallow

+44 (0)20 7282 2949/1050/2948

Downloads

Press release PDF (113.46 KB)

BONESUPPORT™ Receives FDA Approval to Initiate IDE Clinical Study

9th August

BONESUPPORT™ Receives FDA Approval to Initiate IDE Clinical Study

FORTIFY Study to Assess CERAMENT™|G as part of Surgical Repair of Open Diaphyseal Tibial Fractures

Lund, Sweden, 9 August – BONESUPPORT AB, an emerging leader in innovative injectable bioceramic bone substitute products to treat bone voids caused by trauma, infection, disease or related surgery, today announced that it has received approval from the US Food and Drug Administration (FDA) to begin an IDE (Investigational Device Exemption) study with CERAMENT™ G. CERAMENT™ G is an injectable antibiotic-eluting bone graft substitute that provides local sustained delivery of gentamicin. CERAMENT™ G received CE mark approval in February 2013 and is now marketed in 19 countries outside the US.

The FORTIFY study, a randomized multicenter controlled trial, will evaluate the safety and efficacy of CERAMENT™ G as part of surgical repair of open diaphyseal tibial fractures. The trial will enrol up to 230 patients at up to 30 centers globally, with the aim of having at least 50% of the study data coming from US subjects. In addition to evaluating the safety of CERAMENT™ G use, primary endpoints of the study include

- Absence of deep infection at the fracture site

- Absence of secondary procedures (surgical or nonsurgical) intended to promote fracture union

BONESUPPORT anticipates starting the FORTIFY trial by the end of 2016.

CERAMENT™ G combines the bone healing and bone remodeling properties of CERAMENT™ with the antibiotic, gentamicin. CERAMENT™ G drug-eluting properties enable it to provide an initial ultra-high concentration of gentamicin to the environment of the bone fracture and then a longer sustainable dose above the minimum inhibitory concentration (MIC) of many of the bacteria which could cause a deep bone infection at the fracture site. This unique antibiotic-eluting profile helps protect the bone healing process and to promote bone remodeling.

Richard Davies, CEO of BONESUPPORT, said, “The FDA approval of our planned IDE study with CERAMENT G is a key corporate milestone for BONESUPPORT. We are looking forward to beginning the FORTIFY study before the end of 2016. The results of this study will form a key component of our planned PMA to gain US approval for this novel antibiotic-eluting bone graft substitute.”

Ends

Notes to Editor

 

About BONESUPPORT™

BONESUPPORT AB has developed CERAMENT™ as an innovative range of radiopaque injectable osteoconductive bioceramic products that have a proven ability to heal defects by remodeling to host bone in six to twelve months. Our products are effective in treating patients with fractures and bone voids caused by trauma, infection, disease or related surgery. Our lead product, CERAMENT™|BONE VOID FILLER (BVF) addresses important issues facing health care providers, such as avoiding hospital readmissions and revision surgery that result from failed bone healing and infection caused by residual bone voids. CERAMENT|BVF is commercially available in the U.S., EU, S.E. Asia and the Middle East.

CERAMENT's distinctive properties as a drug eluting material have been validated in clinical practice by CERAMENT™|G and CERAMENT™ V, the first CE-marked injectable antibiotic eluting bone graft substitutes. These products provide local sustained delivery of gentamicin and vancomycin, respectively. The local delivery feature enables an initial high concentration of antibiotics to the bone defect and then a longer sustainable dose above the minimal inhibitory concentration (MIC) to protect bone healing and promote bone remodeling.

CERAMENT|G and CERAMENT™ have demonstrated good results in patients with problematic bone infections including osteomyelitis. They are also used prophylactically in patients who are at risk for developing infection. CERAMENT|G and CERAMENT™ V are available in the EU.

BONESUPPORT AB was founded in 1999 by Prof. Lars Lidgren, an internationally respected scientist who has been the President of various musculoskeletal societies. BONESUPPORT’s mission is to bring people with bone and joint diseases back to an active life. The company is based in Lund, Sweden.

bonesupport.com

BONESUPPORT™ is a registered trademark.

Contact Information

Citigate Dewe Rogerson

David Dible, Andrea Bici, Mark Swallow

+44 (0)20 7282 2949/1050/2948

Downloads

Press release PDF (112.52 KB)

BONESUPPORT™ Announces Nature Publication of Pre-Clinical Study Highlighting CERAMENT®’s Attractive Bone Remodeling Properties and as a Local Drug Delivery Platform for Bone Disease

1st June

BONESUPPORT™ Announces Nature Publication of Pre-Clinical Study Highlighting CERAMENT®’s Attractive Bone Remodeling Properties and as a Local Drug Delivery Platform for Bone Disease

 

Lund, Sweden, 1 June, 2016 – BONESUPPORT AB, an emerging leader in innovative injectable bioresorbable bone graft substitute products to treat bone voids caused by trauma, infection, disease or related surgery today announced  the publication of a paper in  Nature Scientific Reports: A Biphasic Calcium Sulphate Hydroxyapatite Carrier Containing Bone Morphogenic Protein-2 and Zoledronic Acid Generates Bone (Raina, D et al., reference below). The paper covers a pre-clinical study which demonstrated that CERAMENT™ loaded with a combination of recombinant human bone morphogenic protein 2 (“rhBMP-2”) plus zoledronic acid (“ZA”) in very low doses was able to quantitatively and qualitatively generate a higher amount of mineralized bone volume. The study also showed In vivo that the mineralized volume was significantly higher when CERAMENT™ was combined with rhBMP-2 and ZA (21.4±5.5mm³) as compared to CERAMENT™ in combination with just rhBMP-2 (10.9±2.1mm³). Raina, D. et al.

The findings highlight the attractive properties of CERAMENT™ as an injectable carrier material that can mimic natural bone matrix. CERAMENT™ benefits from several advantages such as a high degree of protein encapsulation, sustained release behavior and improved surgical handling. The biocompatibility and bioresorbability of the biphasic microporous material which sets in situ make it suitable as a carrier with a controlled release of encapsulated or chemically bound additives. Raina, D. et al.

Authors of the publication stated, “There is a clear need for bone substitutes that can safely and effectively replace autograft via a combination of bone growth and remodeling. There is increasing demand and the absence of a viable solution for replacing large volumes of bone that clearly requires new innovative bone graft solutions. The results that we have published shows that it could be possible to develop a single stage method based on the unique properties of CERAMENT™|BONE VOID FILLER (BVF) to deliver a combination of the rhBMP-2 and ZA locally at the site where significant new bone formation is needed”. Raina, D. et al.

The authors note that previously BMPs have not been proven to induce better bone healing than autograft suggesting that there is a clear need for an improved delivery platform, and that the limitations of delivery methods used to-date have led to varying clinical outcomes. These include carboxymethyl cellulose, bovine particle carriers and collagen sponges, which additionally can cause local inflammatory reaction. The study findings suggest that using CERAMENT™ as a platform to co-deliver a combination of rhBMP-2 and ZA with a synergistic effect can potentially improve the standard of care for patients afflicted with bone disease. Raina, D. et al.

Richard Davies, CEO of bonesupport.commenting on today’s announcement said, “The pre-clinical results in this prestigious publication highlight an unmet medical need for a single-stage delivery platform with properties that not only foster bone healing, but also enable local delivery of a range of therapeutics. It discusses the advantageous properties of CERAMENT™ as a drug eluting material which we have been demonstrating in clinical practice with antibiotic containing CERAMENT™ G & V. We have received favourable physician feedback about the efficacy of these products in the management of patients with osteomyelitis. We are encouraged about the potential of our platform to develop further products to treat specific groups of patients with bone disease. “

Reference

Raina, D. et al. A Biphasic Calcium Sulfate Hydroxapatite Carrier Bone Morphogenic Protein -2 and Zoledronic Acid Generates Bone (2016) Nature Scientific Reports. http://bit.ly/22xgU84

 

Ends

Notes to Editor

 

About BONESUPPORT™

BONESUPPORT AB has developed CERAMENT™ as an innovative range of radiopaque injectable osteoconductive bioceramic products that have a proven ability to heal defects by remodeling to host bone in six to twelve months. Our products are effective in treating patients with fractures and bone voids caused by trauma, infection, disease or related surgery. Our lead product, CERAMENT™|BONE VOID FILLER (BVF) addresses important issues facing health care providers, such as avoiding hospital readmissions and revision surgery that result from failed bone healing and infection caused by residual bone voids. CERAMENT|BVF is commercially available in the U.S., EU, S.E. Asia and the Middle East.

CERAMENT's distinctive properties as a drug eluting material have been validated in clinical practice by CERAMENT™|G and CERAMENT™ V, the first CE-marked injectable antibiotic eluting bone graft substitutes. These products provide local sustained delivery of gentamicin and vancomycin, respectively. The local delivery feature enables an initial high concentration of antibiotics to the bone defect and then a longer sustainable dose above the minimal inhibitory concentration (MIC) to protect bone healing and promote bone remodeling.

CERAMENT|G and CERAMENT™ have demonstrated good results in patients with problematic bone infections including osteomyelitis. They are also used prophylactically in patients who are at risk for developing infection. CERAMENT|G and CERAMENT™ V are available in the EU.

BONESUPPORT AB was founded in 1999 by Prof. Lars Lidgren, an internationally respected scientist who has been the President of various musculoskeletal societies. BONESUPPORT’s mission is to bring people with bone and joint diseases back to an active life. The company is based in Lund, Sweden.

bonesupport.com

BONESUPPORT™ is a registered trademark.

Contact Information

Citigate Dewe Rogerson

David Dible, Andrea Bici, Mark Swallow

+44 (0)20 7282 2949/1050/2948

Downloads

Press release PDF (116.82 KB)

BONESUPPORT® Announces Availability in Europe of CERAMENT™|G in 5 mL Volume to Address Growing Market Demand

1st March

BONESUPPORT® Announces Availability in Europe of CERAMENT™|G in 5 mL Volume to Address Growing Market Demand

CERAMENT™|G 5 mL to be utilized for infection management and prophylaxis in diabetic foot procedures and small extremities

Lund, Sweden, (PRNEWSWIRE) March 1, 2016 – BONESUPPORT™, an emerging leader in injectable bone substitutes for orthopedic trauma, bone infections and instrument augmentation related to orthopedic surgery, today announced an extension to the CERAMENT™|G product portfolio, adding a 5 mL volume to further develop the management of osteomyelitis (OM) and infection prophylaxis in diabetic foot and small extremities. CERAMENT™|G, which releases Gentamicin, received CE-mark in 2013, and is the first injectable antibiotic eluting bone substitute indicated to promote and protect bone healing in the management of bone infection. CERAMENT™|G is now available in 5 mL and 10 mL in CE-mark countries.

The new smaller 5 mL volume further expands the application of CERAMENT™|G in small joint and extremity indications, including osteomyelitis in the Diabetic Foot.  The efficacy of CERAMENT™|G in the management of this indication was recently demonstrated in two studies presented at the 34th Annual Meeting of the European Bone and Infection Society.

“CERAMENT™|G has demonstrated efficacy in the management of bone infections, and the new 5 mL volume will allow us to utilize this product in a larger number of patients with extremity infections as well as prophylactically in indications where a high risk of infection exists,” said Professor Lars Jens Perlick, Chief of Trauma and Orthopaedics, Asklepios Paulinen Klinik Wiesbaden, in Germany.

“We are pleased to be able to address the market’s demand for CERAMENT™|G in a smaller volume,” said Richard Davies, CEO of BONESUPPORT™.  “Physicians in Europe are clearly recognizing the benefits of our novel antibiotic eluting CERAMENT™ technology, and we continue to look forward to initiating a pivotal U.S. clinical trial for CERAMENT™|G in the second quarter of 2016.” 

Ends

Notes to Editor

 

About BONESUPPORT™

BONESUPPORT AB has developed CERAMENT™ as an innovative range of radiopaque injectable osteoconductive bioceramic products that have a proven ability to heal defects by remodeling to host bone in six to twelve months. Our products are effective in treating patients with fractures and bone voids caused by trauma, infection, disease or related surgery. Our lead product, CERAMENT™|BONE VOID FILLER (BVF) addresses important issues facing health care providers, such as avoiding hospital readmissions and revision surgery that result from failed bone healing and infection caused by residual bone voids. CERAMENT|BVF is commercially available in the U.S., EU, S.E. Asia and the Middle East.

CERAMENT's distinctive properties as a drug eluting material have been validated in clinical practice by CERAMENT™|G and CERAMENT™ V, the first CE-marked injectable antibiotic eluting bone graft substitutes. These products provide local sustained delivery of gentamicin and vancomycin, respectively. The local delivery feature enables an initial high concentration of antibiotics to the bone defect and then a longer sustainable dose above the minimal inhibitory concentration (MIC) to protect bone healing and promote bone remodeling.

CERAMENT|G and CERAMENT™ have demonstrated good results in patients with problematic bone infections including osteomyelitis. They are also used prophylactically in patients who are at risk for developing infection. CERAMENT|G and CERAMENT™ V are available in the EU.

BONESUPPORT AB was founded in 1999 by Prof. Lars Lidgren, an internationally respected scientist who has been the President of various musculoskeletal societies. BONESUPPORT’s mission is to bring people with bone and joint diseases back to an active life. The company is based in Lund, Sweden.

bonesupport.com

BONESUPPORT™ is a registered trademark.

Contact Information

Citigate Dewe Rogerson

David Dible, Andrea Bici, Mark Swallow

+44 (0)20 7282 2949/1050/2948

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BONESUPPORT™ Reports Expansion of Company's CERAMENT® Drug Eluting Procedure Registry

2nd February

BONESUPPORT™ Reports Expansion of Company's CERAMENT® Drug Eluting Procedure Registry

CERAMENT™|G registry now includes 230 cases conducted in 18 hospitals across 9 countries

Registry now updated to include CERAMENT™ V procedures

Lund, Sweden, (PRNEWSWIRE) February 2, 2016 – BONESUPPORT™, an emerging leader in injectable bone substitutes for orthopedic trauma, bone infections and instrument augmentation related to orthopedic surgery, today provided an update on the Company’s CERAMENT™ procedure registry, established by BONESUPPORT™ in February 2014 as part of the proactive post-market surveillance process for the Company’s novel antibiotic eluting injectable bone substitutes. The CERAMENT™|G registry now includes 230 cases conducted in 18 hospitals across 9 countries. In addition, the registry has recently been updated to include CERAMENT™ V procedures.

The CERAMENT™|G registry includes a variety of complex procedures, including bone tumors, primary and revision hip and knee prostheses, osteomyelitis and infected diabetic foot.  Moreover, the registry participants include a number of world-renowned surgeons, including Professor Carlo Romanò, Istituto Ortopedico Galeazzi, Milan Italy, Mr. Martin McNally, Nuffield Orthopaedic Centre in Oxford, United Kingdom and Professor Guido Wanner, University Hospital of Zurich, Switzerland.  The CERAMENT™ registry provides the ability to add more hospitals, more indications and more product line extensions and is one of the most robust registries in the industry.

“This important registry offers hospitals the opportunity to share CERAMENT™ data with a view to analyzing inter-country or cross-country trends,” said Professor McNally. “I am pleased to be participating in, and contributing to this registry.  We have shown that CERAMENT™|G is a safe and effective addition to the management of many complex indications, including chronic osteomyelitis, and look forward to generating further data to confirm this.”

“We are excited about the diverse set of procedures and compelling data being generated in our CERAMENT™ registry,” said Richard Davies, CEO of BONESUPPORT™. “This registry both ensures vigilance in the post-marketing surveillance for our products, and allows the data generated from these complex procedures to be collected and stored in a central location. We intend to work with our surgeon participants to ensure publication of this data in the future.”

Ends

Notes to Editor

 

About BONESUPPORT™

BONESUPPORT AB has developed CERAMENT™ as an innovative range of radiopaque injectable osteoconductive bioceramic products that have a proven ability to heal defects by remodeling to host bone in six to twelve months. Our products are effective in treating patients with fractures and bone voids caused by trauma, infection, disease or related surgery. Our lead product, CERAMENT™|BONE VOID FILLER (BVF) addresses important issues facing health care providers, such as avoiding hospital readmissions and revision surgery that result from failed bone healing and infection caused by residual bone voids. CERAMENT|BVF is commercially available in the U.S., EU, S.E. Asia and the Middle East.

CERAMENT's distinctive properties as a drug eluting material have been validated in clinical practice by CERAMENT™|G and CERAMENT™ V, the first CE-marked injectable antibiotic eluting bone graft substitutes. These products provide local sustained delivery of gentamicin and vancomycin, respectively. The local delivery feature enables an initial high concentration of antibiotics to the bone defect and then a longer sustainable dose above the minimal inhibitory concentration (MIC) to protect bone healing and promote bone remodeling.

CERAMENT|G and CERAMENT™ have demonstrated good results in patients with problematic bone infections including osteomyelitis. They are also used prophylactically in patients who are at risk for developing infection. CERAMENT|G and CERAMENT™ V are available in the EU.

BONESUPPORT AB was founded in 1999 by Prof. Lars Lidgren, an internationally respected scientist who has been the President of various musculoskeletal societies. BONESUPPORT’s mission is to bring people with bone and joint diseases back to an active life. The company is based in Lund, Sweden.

bonesupport.com

BONESUPPORT™ is a registered trademark.

Contact Information

Citigate Dewe Rogerson

David Dible, Andrea Bici, Mark Swallow

+44 (0)20 7282 2949/1050/2948

Downloads

Press release PDF (109.46 KB)

BONESUPPORT™ Announces Appointment of Life Sciences Industry Veteran, Richard Davies, as New Chief Executive Officer

22nd January

BONESUPPORT™ Announces Appointment of Life Sciences Industry Veteran, Richard Davies, as New Chief Executive Officer

Mr. Davies Brings over 25 Years of Life Sciences Industry Experience to BONESUPPORT™

Current Chief Executive Officer, Lloyd Diamond, to Transition to Role of Chief Business Officer

Lund, Sweden, (PRNEWSWIRE) January 22, 2016 – BONESUPPORT™, an emerging leader in both injectable bone substitutes and innovative drug eluting bone scaffold technology for orthopedic trauma, bone infections and instrument augmentation related to orthopedic surgery, announced today that the Company has appointed Richard Davies as BONESUPPORT™’s new Chief Executive Officer, effective immediately. Mr. Davies is a senior commercial leader in the life sciences industry with 25 years of global experience in all aspects of sales / marketing and country / regional leadership, a track record of devising and executing growth strategies and delivering successful results in complex situations.

BONESUPPORT™’s current Chief Executive Officer, Lloyd Diamond, will transition to the role of Chief Business Officer, effective immediately. Mr. Diamond will re-locate back to the U.S., establishing an executive level presence for the Company’s largest market. During his time with BONESUPPORT™, Mr. Diamond secured an important distribution agreement in the U.S. with the world’s largest orthopedic market player, Zimmer Biomet, and transformed the Company from a Research and Development organization to a fully commercial group, with more than 20,000 CERAMENT™ procedures performed worldwide.

“I am proud of the transition BONESUPPORT™ has made from an R&D organization to a global commercial company in the four years I have had the pleasure of serving as CEO,” said Mr. Diamond. “My new role as Chief Business Officer will allow me to focus on further driving CERAMENT™ commercial growth, particularly in the U.S. market."

Mr. Davies previously spent nearly four years at Hospira, where he served as Chief Commercial Officer. While at Hospira, he drove growth, globalization and modernization across the business. Mr. Davies’ efforts led the company to an acceleration of revenue growth to 12% per year. Hospira was acquired by Pfizer at the end of 2015. Prior to Hospira, Mr. Davies spent nine years in increasingly senior leadership positions at Amgen in Europe, Australia and the U.S. His roles encompassed a start up of clinical and commercial operations in CEE, leadership of Australia and New Zealand and leadership of the U.S. Inflammation sales group, commercializing Enbrel, the most prescribed biologic medicine in the U.S. at that time. His most recent position at Amgen was General Manager, Japan and Asia Pacific.  Mr. Davies began his career at Eli Lilly, spending 13 years in increasingly senior positions.

“First, on behalf of the entire Board, I’d like to thank Lloyd for his dedication and numerous achievements as BONESUPPORT™’s CEO over the past four years,” said Oern R. Stuge, M.D., BONESUPPORT™’s Chairman of the Board. “We are delighted to welcome Richard to BONESUPPORT™. His vast pharmaceutical experience will be key to leveraging the drug eluting capabilities of CERAMENT™. I look forward to working closely with Richard as we focus on the many opportunities ahead of BONESUPPORT™ in the coming years.”

“I am pleased to be joining BONESUPPORT™ as CEO at such a critical juncture in the Company’s history,” said Mr. Davies. “The technology BONESUPPORT™ has developed offers important health benefits to patients and represents significant upside value potential for investors. Lloyd has done a tremendous job in advancing the Company and I look forward to working with him and the team to continue to accelerate this growth.”

Mr. Davies is currently Chairman of the Board of Alvotech Iceland and has previously served on the Board of Zydus Hospira Oncology Products Ltd., and of several trade associations in Poland and Australia. He holds a B.Sc. in Applied Chemistry from Portsmouth University, and an MBA from Warwick Business School.

Ends

Notes to Editor

 

About BONESUPPORT™

BONESUPPORT AB has developed CERAMENT™ as an innovative range of radiopaque injectable osteoconductive bioceramic products that have a proven ability to heal defects by remodeling to host bone in six to twelve months. Our products are effective in treating patients with fractures and bone voids caused by trauma, infection, disease or related surgery. Our lead product, CERAMENT™|BONE VOID FILLER (BVF) addresses important issues facing health care providers, such as avoiding hospital readmissions and revision surgery that result from failed bone healing and infection caused by residual bone voids. CERAMENT|BVF is commercially available in the U.S., EU, S.E. Asia and the Middle East.

CERAMENT's distinctive properties as a drug eluting material have been validated in clinical practice by CERAMENT™|G and CERAMENT™ V, the first CE-marked injectable antibiotic eluting bone graft substitutes. These products provide local sustained delivery of gentamicin and vancomycin, respectively. The local delivery feature enables an initial high concentration of antibiotics to the bone defect and then a longer sustainable dose above the minimal inhibitory concentration (MIC) to protect bone healing and promote bone remodeling.

CERAMENT|G and CERAMENT™ have demonstrated good results in patients with problematic bone infections including osteomyelitis. They are also used prophylactically in patients who are at risk for developing infection. CERAMENT|G and CERAMENT™ V are available in the EU.

BONESUPPORT AB was founded in 1999 by Prof. Lars Lidgren, an internationally respected scientist who has been the President of various musculoskeletal societies. BONESUPPORT’s mission is to bring people with bone and joint diseases back to an active life. The company is based in Lund, Sweden.

bonesupport.com

BONESUPPORT™ is a registered trademark.

Contact Information

Citigate Dewe Rogerson

David Dible, Andrea Bici, Mark Swallow

+44 (0)20 7282 2949/1050/2948

Downloads

Press release PDF (112.24 KB)

BONESUPPORT™ Announces 20,000 Patients Now Treated with CERAMENT®

11th January

BONESUPPORT™ Announces 20,000 Patients Now Treated with CERAMENT®

 

Lund, Sweden, (PRNEWSWIRE) January 11, 2016 – BONESUPPORT™, an emerging leader in injectable bone substitutes for orthopedic trauma, bone infections and instrument augmentation related to orthopedic surgery, announced today the Company has reached a significant milestone with more than 20,000 patients treated worldwide with CERAMENT™, a novel injectable and moldable bone substitute with unique drug eluting capabilities. Adoption of the CERAMENT™ product portfolio continues to grow and gain momentum globally.

“In the past four years, we have transitioned from a Research and Development focused company to a commercial phase company,” said Lloyd Diamond, CEO of BONESUPPORT™. “In the U.S., CERAMENT™ procedure growth is being driven by the continued commercial progress BONESUPPORT™ and our U.S. distribution partner, Zimmer Biomet, continue to achieve.  In Europe, the strong physician demand for BONESUPPORT’s first to market injectable antibiotic eluting products, CERAMENT™|G (gentamicin) and CERAMENT™ V (vancomycin), indicated to promote and protect bone healing in the management of bone infections, is fueling significant procedure growth in this region and in new markets with new indications.”

“Achieving this milestone of 20,000 CERAMENT™ procedures is not only recognition that our commercialization strategy is working, but validation that the utility of our novel technologies is resonating well with the global market place,” continued Mr. Diamond. “We look forward to expanding our product portfolio and extending the benefits to additional surgeons and patients worldwide.”

Ends

Notes to Editor

 

About BONESUPPORT™

BONESUPPORT AB has developed CERAMENT™ as an innovative range of radiopaque injectable osteoconductive bioceramic products that have a proven ability to heal defects by remodeling to host bone in six to twelve months. Our products are effective in treating patients with fractures and bone voids caused by trauma, infection, disease or related surgery. Our lead product, CERAMENT™|BONE VOID FILLER (BVF) addresses important issues facing health care providers, such as avoiding hospital readmissions and revision surgery that result from failed bone healing and infection caused by residual bone voids. CERAMENT|BVF is commercially available in the U.S., EU, S.E. Asia and the Middle East.

CERAMENT's distinctive properties as a drug eluting material have been validated in clinical practice by CERAMENT™|G and CERAMENT™ V, the first CE-marked injectable antibiotic eluting bone graft substitutes. These products provide local sustained delivery of gentamicin and vancomycin, respectively. The local delivery feature enables an initial high concentration of antibiotics to the bone defect and then a longer sustainable dose above the minimal inhibitory concentration (MIC) to protect bone healing and promote bone remodeling.

CERAMENT|G and CERAMENT™ have demonstrated good results in patients with problematic bone infections including osteomyelitis. They are also used prophylactically in patients who are at risk for developing infection. CERAMENT|G and CERAMENT™ V are available in the EU.

BONESUPPORT AB was founded in 1999 by Prof. Lars Lidgren, an internationally respected scientist who has been the President of various musculoskeletal societies. BONESUPPORT’s mission is to bring people with bone and joint diseases back to an active life. The company is based in Lund, Sweden.

bonesupport.com

BONESUPPORT™ is a registered trademark.

Contact Information

Citigate Dewe Rogerson

David Dible, Andrea Bici, Mark Swallow

+44 (0)20 7282 2949/1050/2948

Downloads

Press release PDF (106.59 KB)

BONESUPPORT™ Announces CERAMENT® Focused Research Collaboration with Rigshospitalet, Copenhagen University Hospital

7th January

BONESUPPORT™ Announces CERAMENT® Focused Research Collaboration with Rigshospitalet, Copenhagen University Hospital

Rigshospitalet to evaluate CERAMENT™ platform for use in bone tumors

Lund, Sweden, (PRNEWSWIRE) January 7, 2016 – BONESUPPORT™, an emerging leader in injectable bone substitutes for orthopedic trauma, bone infections and instrument augmentation related to orthopedic surgery, today announced that the Company has signed a research collaboration with Rigshospitalet, Copenhagen University Hospital, the largest hospital in Denmark, whereby the institution will evaluate BONESUPPORT™’s platform technology, CERAMENT™, in the management of bone tumors. 

The study will retrospectively evaluate clinical results using bone allografts, and prospectively evaluate clinical results using CERAMENT™lBONE VOID FILLER and gentamicin eluting CERAMENT™lG, for prophylactic use in bone tumor patients. CERAMENT™ will also be evaluated in combination with different substances in order to achieve enhanced bone healing. 

Surgical management of bone tumors can create a residual bone defect in highly compromised patients, which requires void filling to prevent infection or fracture. Synthetic bone substitutes offer significant advantages over traditional autograft and allograft, which are associated with high morbidity and risk of disease transmission.

“We are excited to evaluate the CERAMENT™ technology platform in this research collaboration,” said Michael Mørk-Petersen, Professor, MD, DMSc, Rigshospitalet, who will oversee the study. “Both autologous bone and allograft have some disadvantages and risks associated with their use.  We believe CERAMENT™ can provide a safe and effective alternative long-term solution to these technologies.”

“BONESUPPORT™ is pleased to enter into this collaboration with such a prestigious medical institution,” said Dr. Eva Lidén, VP of Research and Development of BONESUPPORT™. “Our CERAMENT™ technology platform continues to gain momentum with the physician community in Europe, and we will continue to invest in important research to validate our technology and improve upon the standard of care.”

CERAMENT™|G is CE-mark approved and is commercially available in parts of Europe, SE Asia and the Middle East.  CERAMENT™|BONE VOID FILLER is FDA cleared and CE-mark approved and is commercially available in the U.S., Canada, parts of Europe, SE Asia and the Middle East.  Zimmer Biomet is the exclusive distributor of CERAMENT™|BONE VOID FILLER in the U.S.

Ends

Notes to Editor

 

About BONESUPPORT™

BONESUPPORT AB has developed CERAMENT™ as an innovative range of radiopaque injectable osteoconductive bioceramic products that have a proven ability to heal defects by remodeling to host bone in six to twelve months. Our products are effective in treating patients with fractures and bone voids caused by trauma, infection, disease or related surgery. Our lead product, CERAMENT™|BONE VOID FILLER (BVF) addresses important issues facing health care providers, such as avoiding hospital readmissions and revision surgery that result from failed bone healing and infection caused by residual bone voids. CERAMENT|BVF is commercially available in the U.S., EU, S.E. Asia and the Middle East.

CERAMENT's distinctive properties as a drug eluting material have been validated in clinical practice by CERAMENT™|G and CERAMENT™ V, the first CE-marked injectable antibiotic eluting bone graft substitutes. These products provide local sustained delivery of gentamicin and vancomycin, respectively. The local delivery feature enables an initial high concentration of antibiotics to the bone defect and then a longer sustainable dose above the minimal inhibitory concentration (MIC) to protect bone healing and promote bone remodeling.

CERAMENT|G and CERAMENT™ have demonstrated good results in patients with problematic bone infections including osteomyelitis. They are also used prophylactically in patients who are at risk for developing infection. CERAMENT|G and CERAMENT™ V are available in the EU.

BONESUPPORT AB was founded in 1999 by Prof. Lars Lidgren, an internationally respected scientist who has been the President of various musculoskeletal societies. BONESUPPORT’s mission is to bring people with bone and joint diseases back to an active life. The company is based in Lund, Sweden.

bonesupport.com

BONESUPPORT™ is a registered trademark.

Contact Information

Citigate Dewe Rogerson

David Dible, Andrea Bici, Mark Swallow

+44 (0)20 7282 2949/1050/2948

Downloads

Press release PDF (109.26 KB)

BONESUPPORT™ Announces Positive Data Highlighting the Use of CERAMENT®|G in the Management of Osteomyelitis in the Infected Diabetic Foot

5th January

BONESUPPORT™ Announces Positive Data Highlighting the Use of CERAMENT®|G in the Management of Osteomyelitis in the Infected Diabetic Foot

Two separate studies confirm efficacy of CERAMENT™|G, an antibiotic eluting bone substitute, as a new option in the surgical management of osteomyelitis in the infected diabetic foot.

Lund, Sweden, (PRNEWSWIRE) January 5, 2016 – BONESUPPORT™, an emerging leader in injectable bone substitutes for orthopedic trauma, bone infections and instrument augmentation related to orthopedic surgery, today announced data from two studies confirming the efficacy of the Company’s CERAMENT™ antibiotic eluting bone substitute technology as a step in the management of osteomyelitis (OM) in infected diabetic foot. CERAMENT™|G, which releases Gentamicin, received CE-mark in 2013, and is the first approved antibiotic eluting bone substitute indicated to promote and protect bone healing in the management of bone infections.

Contiguous bone infection is a common complication of diabetic foot ulcers, and overall approximately 20% of patients with a diabetic foot infection (and over 60% of those with severe infections) have underlying osteomyelitis.¹. Prevalence of diabetes is growing rapidly and is the most common cause of non-traumatic lower limb amputation, with approximately 30% of patients with a diabetic foot ulcer leading to amputation. The risk for amputation in acute diabetic infections is four times higher with OM than with soft tissue infection alone². Additionally 50% of patients will go on to another amputation within 3-5 years, and 70% percent of patients die within 5 years of an amputation for diabetes.

Overall, the studies confirmed previously unpublished experience with CERAMENT™|G and published off label clinical use of CERAMENT™ which was shown to induce bone and soft tissue healing and preservation of proper anatomy in the infected diabetic foot. Of significance, 11 of 12 patients who had mid-foot or hind foot partial resections healed rapidly, with the other patient follow up ongoing.  In the second study six patients with OM of the metatarsal head were managed with CERAMENT™|G, with none requiring additional surgery.

“The results of these studies confirm that CERAMENT™|G has the potential to be an effective new surgical option for patients with osteomyelitis,” said Enrico Brocco, Chief, Diabetic Foot Unit, Policlinico Abano Terme, Diabetic Foot Referral Center, Italy, and author of one of the studies. “In these studies, CERAMENT™|G was associated with the rapid resolution of osteomyelitis, rapid soft tissue closure and preservation of the foot structure. We are very optimistic that CERAMENT™|G holds great promise in the management of osteomyelitis in diabetic foot ulcers.”

“The data generated from these studies support the feedback we’ve received from European physicians regarding the efficacy of CERAMENT™|G,” said Lloyd Diamond, CEO of BONESUPPORT™. “Importantly, our physician adoption rate in Europe continues to grow significantly, and we anticipate initiating a pivotal U.S. clinical trial for CERAMENT™|G in the second quarter of 2016.” 

The results from these studies were presented at the 34th Annual Meeting of the European Bone and Infection Society in September.  BONESUPPORT™ is currently pursuing a pathway for FDA clearance in order to bring this novel treatment to the U.S.

References

1. Eneroth M, Larsson J, Apelqvist J.  Deep foot infections in patients with diabetes and foot ulcer: an entity with different characteristics, treatments, and prognosis. J Diabetes Complications 1999;13:254–263.

2. Mutluoglu M, Sivrioglu AK, Eroglu M, Uzun G, Turhan V, Ay H, et al. The implications of the presence of osteomyelitis on outcomes of infected diabetic foot wounds. Scand J Infect Dis. 2013;45:497–503.

 

Ends

Notes to Editor

 

About BONESUPPORT™

BONESUPPORT AB has developed CERAMENT™ as an innovative range of radiopaque injectable osteoconductive bioceramic products that have a proven ability to heal defects by remodeling to host bone in six to twelve months. Our products are effective in treating patients with fractures and bone voids caused by trauma, infection, disease or related surgery. Our lead product, CERAMENT™|BONE VOID FILLER (BVF) addresses important issues facing health care providers, such as avoiding hospital readmissions and revision surgery that result from failed bone healing and infection caused by residual bone voids. CERAMENT|BVF is commercially available in the U.S., EU, S.E. Asia and the Middle East.

CERAMENT's distinctive properties as a drug eluting material have been validated in clinical practice by CERAMENT™|G and CERAMENT™ V, the first CE-marked injectable antibiotic eluting bone graft substitutes. These products provide local sustained delivery of gentamicin and vancomycin, respectively. The local delivery feature enables an initial high concentration of antibiotics to the bone defect and then a longer sustainable dose above the minimal inhibitory concentration (MIC) to protect bone healing and promote bone remodeling.

CERAMENT|G and CERAMENT™ have demonstrated good results in patients with problematic bone infections including osteomyelitis. They are also used prophylactically in patients who are at risk for developing infection. CERAMENT|G and CERAMENT™ V are available in the EU.

BONESUPPORT AB was founded in 1999 by Prof. Lars Lidgren, an internationally respected scientist who has been the President of various musculoskeletal societies. BONESUPPORT’s mission is to bring people with bone and joint diseases back to an active life. The company is based in Lund, Sweden.

bonesupport.com

BONESUPPORT™ is a registered trademark.

Contact Information

Citigate Dewe Rogerson

David Dible, Andrea Bici, Mark Swallow

+44 (0)20 7282 2949/1050/2948

Downloads

Press release PDF (120.21 KB)

Press releases

2015

Press releases

December 10, 2015

BONESUPPORT™ Announces Results Of CERAMENT™|BONE VOID FILLER Prospective Pilot Study Demonstrating Complete Bone Remodeling In Benign Bone Tumors

November 13, 2015

BONESUPPORT™ To Present Corporate Overview at Stifel 2015 Healthcare Conference

October 20, 2015

First U.S. Study Of CERAMENT™ Antibiotic Eluting Bone Substitute In The Management Of Chronic Osteomyelitis Presented At EBJIS

October 6, 2015

New Data From Oxford University Hospitals Demonstrate Superior Outcome With CERAMENT™ Antibiotic Eluting Bone Substitute Compared To Collagen And Calcium Sulfate In The Management Of Chronic Osteomyelitis

September 24, 2015

CERAMENT™ Antibiotic Eluting Bone Substitutes For The Management Of Osteomyelitis Prominent At The 34th Annual Meeting Of The European Bone & Joint Infection Society (EBJIS)

August 25, 2015 

CERAMENT™ With Antibiotics To Be Featured Extensively At The 34th Annual Meeting Of The European Bone & Joint Infection Society (EBJIS)

June 23, 2015

CERAMENT™ Study Recognized At The 16th EFORT Congress In Prague

May 27, 2015

CERAMENT™|G Shown To Increase Bone Formation And Decrease Infection

May 13, 2015

BONESUPPORT Earns Frost & Sullivan's 2015 Best Practices Award For Its Novel Product, CERAMENT™

April 29, 2015

BONESUPPORT Announces CE-Mark of CERAMENT™|V, the First Injectable Vancomycin Eluting Bone Substitute in the Management of Osteomyelitis

April 23, 2015

Orthopedics This Week Biologics Feature focused on CERAMENT™|G disruptive technology

April 15, 2015

BONESUPPORT Closes $14 Million In Funding Led By Major Scandinavian Pension Fund

February 25, 2015

BONESUPPORT Receives Approval to Market CERAMENT™ in India

 

Notes to Editor

 

About BONESUPPORT™

BONESUPPORT AB has developed CERAMENT™ as an innovative range of radiopaque injectable osteoconductive bioceramic products that have a proven ability to heal defects by remodeling to host bone in six to twelve months. Our products are effective in treating patients with fractures and bone voids caused by trauma, infection, disease or related surgery. Our lead product, CERAMENT™|BONE VOID FILLER (BVF) addresses important issues facing health care providers, such as avoiding hospital readmissions and revision surgery that result from failed bone healing and infection caused by residual bone voids. CERAMENT|BVF is commercially available in the U.S., EU, S.E. Asia and the Middle East.

CERAMENT's distinctive properties as a drug eluting material have been validated in clinical practice by CERAMENT™|G and CERAMENT™ V, the first CE-marked injectable antibiotic eluting bone graft substitutes. These products provide local sustained delivery of gentamicin and vancomycin, respectively. The local delivery feature enables an initial high concentration of antibiotics to the bone defect and then a longer sustainable dose above the minimal inhibitory concentration (MIC) to protect bone healing and promote bone remodeling.

CERAMENT|G and CERAMENT™ have demonstrated good results in patients with problematic bone infections including osteomyelitis. They are also used prophylactically in patients who are at risk for developing infection. CERAMENT|G and CERAMENT™ V are available in the EU.

BONESUPPORT AB was founded in 1999 by Prof. Lars Lidgren, an internationally respected scientist who has been the President of various musculoskeletal societies. BONESUPPORT’s mission is to bring people with bone and joint diseases back to an active life. The company is based in Lund, Sweden.

bonesupport.com

BONESUPPORT™ is a registered trademark.

Contact Information

Citigate Dewe Rogerson

David Dible, Andrea Bici, Mark Swallow

+44 (0)20 7282 2949/1050/2948

Downloads

Press release PDF (115.16 KB)

Press releases

2014

Press releases

December 8, 2014

Leading Bone Repair Company BONESUPPORT and Regenerative Medicine Company Orthocell Ltd Announce a Heads of Agreement

September 24, 2014 

Twelve-Month Follow-Up Of CERAMENT™ With Gentamicin Confirms Significant And Sustained Eradication Of Chronic Infection And Demonstrated Formation Of New Bone

September 9, 2014

CERAMENT™ With Antibiotics To Be Featured Prominently At 33rd Annual Meeting Of The European Bone & Joint Infection Society (EBJIS)

August 5, 2014 

CERAMENT™|G Featured In Documentary 'The Orthopaedic Revolution: Treating Osteomyelitis'

June 19, 2014

BONESUPPORT AB Announces CHUV In Switzerland Initiates Study Of CERAMENT™|G For One-Stage Surgical Revision Of Bone Infections

April 30, 2014

New CERAMENT™ App Available on App Store - Features clinical indications for CERAMENT™|BONE VOID FILLER

April 15, 2014

First CERAMENT™|G Study With Local Gentamicin Elution Shows Safe Bone Healing With Effective New Bone Ingrowth In Osteomyelitis Patients

March 12, 2014

CERTiFy (CERAMENT™|Tibia Fracture) Study Protocol Published In TRIALS

March 11, 2014

BONESUPPORT AB Announces New Drilling Performance Capability For CERAMENT™|BONE VOID FILLER

February 20, 2014

Launch Of New CERAMENT™|G Registry To Collect Data In The Management Of Bone Infection

 

Notes to Editor

 

About BONESUPPORT™

BONESUPPORT AB has developed CERAMENT™ as an innovative range of radiopaque injectable osteoconductive bioceramic products that have a proven ability to heal defects by remodeling to host bone in six to twelve months. Our products are effective in treating patients with fractures and bone voids caused by trauma, infection, disease or related surgery. Our lead product, CERAMENT™|BONE VOID FILLER (BVF) addresses important issues facing health care providers, such as avoiding hospital readmissions and revision surgery that result from failed bone healing and infection caused by residual bone voids. CERAMENT|BVF is commercially available in the U.S., EU, S.E. Asia and the Middle East.

CERAMENT's distinctive properties as a drug eluting material have been validated in clinical practice by CERAMENT™|G and CERAMENT™ V, the first CE-marked injectable antibiotic eluting bone graft substitutes. These products provide local sustained delivery of gentamicin and vancomycin, respectively. The local delivery feature enables an initial high concentration of antibiotics to the bone defect and then a longer sustainable dose above the minimal inhibitory concentration (MIC) to protect bone healing and promote bone remodeling.

CERAMENT|G and CERAMENT™ have demonstrated good results in patients with problematic bone infections including osteomyelitis. They are also used prophylactically in patients who are at risk for developing infection. CERAMENT|G and CERAMENT™ V are available in the EU.

BONESUPPORT AB was founded in 1999 by Prof. Lars Lidgren, an internationally respected scientist who has been the President of various musculoskeletal societies. BONESUPPORT’s mission is to bring people with bone and joint diseases back to an active life. The company is based in Lund, Sweden.

bonesupport.com

BONESUPPORT™ is a registered trademark.

Contact Information

Citigate Dewe Rogerson

David Dible, Andrea Bici, Mark Swallow

+44 (0)20 7282 2949/1050/2948

Downloads

Press release PDF (111.68 KB)

Press releases

2013

Press releases

November 25, 2013

Five-year Follow-up of Patients Treated with Radius Osteotomy and a Biphasic Absorbable Bone Substitute

November 19, 2013

18th November was EU antibiotic awareness day and the commencement of US CDC’s ‘Get Smart About Antibiotics Week’ both highlighting the Worldwide threat of antibiotic resistance

October 29, 2013

Comprehensive Summary Of Preclinical Data And Clinical Applications Of CERAMENT™|BONE VOID FILLER Published In Expert Review Of Medical Devices

October 28, 2013

Five-Year Follow-Up Data on CERAMENT™|BONE VOID FILLER Demonstrates Long-Term Safety and Long-Lasting Bone Mineral Density Improvement in Osteoporotic Patients

October 24, 2013

Great poster presentation on CERAMENT™ in foot and ankle indications, surgeon is Dr DiDomenico

October 24, 2013

BONESUPPORT™ demonstrates Corporate Social Responsibility by supporting humanitarian work in Rwanda

September 10, 2013

BONESUPPORT AB Announces the Publication of a Study Evaluating CERAMENT™|BONE VOID FILLER's Effect on Interface Strength in a Cementless Prosthesis Animal Model

May 7, 2013

BONESUPPORT AB Returns From Medical Mission To Rwanda - CERAMENT™|G Used in the Management of Osteomyelitis

April 18, 2013

BONESUPPORT AB Plans Medical Mission To Deliver CERAMENT™|G To University Teaching Hospital Of Butare (CHUB)

April 16, 2013

BONESUPPORT™ SNNLive Video Interview with StockNewsNow.com at the Sachs Forum 2013

April 12, 2013

32nd EBJIS Conference in Prague FREE PRE-WORKSHOP: Current Topics in Local Antibiotic Delivery for Osteomyelitis Management

March 27, 2013

The University of Mainz Initiates CERAMENT™| Tibia Fracture Study (CERTiFy)

March 8, 2013

BONESUPPORT Announces CE-mark And Launch Of CERAMENT™|G The First Injectable Gentamicin Eluting Bone Substitute To Promote And Protect Bone Healing In Osteomyelitis

 

Notes to Editor

 

About BONESUPPORT™

BONESUPPORT AB has developed CERAMENT™ as an innovative range of radiopaque injectable osteoconductive bioceramic products that have a proven ability to heal defects by remodeling to host bone in six to twelve months. Our products are effective in treating patients with fractures and bone voids caused by trauma, infection, disease or related surgery. Our lead product, CERAMENT™|BONE VOID FILLER (BVF) addresses important issues facing health care providers, such as avoiding hospital readmissions and revision surgery that result from failed bone healing and infection caused by residual bone voids. CERAMENT|BVF is commercially available in the U.S., EU, S.E. Asia and the Middle East.

CERAMENT's distinctive properties as a drug eluting material have been validated in clinical practice by CERAMENT™|G and CERAMENT™ V, the first CE-marked injectable antibiotic eluting bone graft substitutes. These products provide local sustained delivery of gentamicin and vancomycin, respectively. The local delivery feature enables an initial high concentration of antibiotics to the bone defect and then a longer sustainable dose above the minimal inhibitory concentration (MIC) to protect bone healing and promote bone remodeling.

CERAMENT|G and CERAMENT™ have demonstrated good results in patients with problematic bone infections including osteomyelitis. They are also used prophylactically in patients who are at risk for developing infection. CERAMENT|G and CERAMENT™ V are available in the EU.

BONESUPPORT AB was founded in 1999 by Prof. Lars Lidgren, an internationally respected scientist who has been the President of various musculoskeletal societies. BONESUPPORT’s mission is to bring people with bone and joint diseases back to an active life. The company is based in Lund, Sweden.

bonesupport.com

BONESUPPORT™ is a registered trademark.

Contact Information

Citigate Dewe Rogerson

David Dible, Andrea Bici, Mark Swallow

+44 (0)20 7282 2949/1050/2948

Downloads

Press release PDF (113.44 KB)

Press releases

2012

Press releases

December 14, 2012

BONESUPPORT™ features on a billboard in Times Square NYC USA announcing the Red Herring Global Top 100 Award

December 6, 2012

BONESUPPORT Selected As A 2012 Red Herring Top 100 Global

September 5, 2012

BONESUPPORT™ ANNOUNCES EXCLUSIVE SUPPLY AND DISTRIBUTION AGREEMENT WITH BIOMET, INC. FOR BONESUPPORT™'S PROPRIETARY CERAMENT™|BONE VOID FILLER - Agreement Covers Distribution Rights of CERAMENT in United States and Canada

July 2, 2012

BONESUPPORT Names Mr. Offer Nonhoff As New Chief Financial Officer

June 19, 2012

BONESUPPORT Closes Second Tranche of Funding

May 1, 2012

BONESUPPORT Receives Red Herring 2012 Top 100 Europe Award

April 17, 2012

BONESUPPORT™ appoints Andreas Muchowski to VP of sales Germany

April 4, 2012

CEO 100 Day Report - Increasing Sales of CERAMENT™ through New Distribution Channels Among Top Priority

March 27, 2012

BONESUPPORT Launches New Web Site

Janaury 2, 2012

Fredrik Lindberg is this year’s Ideon prizewinner

 

Notes to Editor

 

About BONESUPPORT™

BONESUPPORT AB has developed CERAMENT™ as an innovative range of radiopaque injectable osteoconductive bioceramic products that have a proven ability to heal defects by remodeling to host bone in six to twelve months. Our products are effective in treating patients with fractures and bone voids caused by trauma, infection, disease or related surgery. Our lead product, CERAMENT™|BONE VOID FILLER (BVF) addresses important issues facing health care providers, such as avoiding hospital readmissions and revision surgery that result from failed bone healing and infection caused by residual bone voids. CERAMENT|BVF is commercially available in the U.S., EU, S.E. Asia and the Middle East.

CERAMENT's distinctive properties as a drug eluting material have been validated in clinical practice by CERAMENT™|G and CERAMENT™ V, the first CE-marked injectable antibiotic eluting bone graft substitutes. These products provide local sustained delivery of gentamicin and vancomycin, respectively. The local delivery feature enables an initial high concentration of antibiotics to the bone defect and then a longer sustainable dose above the minimal inhibitory concentration (MIC) to protect bone healing and promote bone remodeling.

CERAMENT|G and CERAMENT™ have demonstrated good results in patients with problematic bone infections including osteomyelitis. They are also used prophylactically in patients who are at risk for developing infection. CERAMENT|G and CERAMENT™ V are available in the EU.

BONESUPPORT AB was founded in 1999 by Prof. Lars Lidgren, an internationally respected scientist who has been the President of various musculoskeletal societies. BONESUPPORT’s mission is to bring people with bone and joint diseases back to an active life. The company is based in Lund, Sweden.

bonesupport.com

BONESUPPORT™ is a registered trademark.

Contact Information

Citigate Dewe Rogerson

David Dible, Andrea Bici, Mark Swallow

+44 (0)20 7282 2949/1050/2948

Downloads

Press release PDF (109.03 KB)

Press releases

2011

Press releases

Notes to Editor

 

About BONESUPPORT™

BONESUPPORT AB has developed CERAMENT™ as an innovative range of radiopaque injectable osteoconductive bioceramic products that have a proven ability to heal defects by remodeling to host bone in six to twelve months. Our products are effective in treating patients with fractures and bone voids caused by trauma, infection, disease or related surgery. Our lead product, CERAMENT™|BONE VOID FILLER (BVF) addresses important issues facing health care providers, such as avoiding hospital readmissions and revision surgery that result from failed bone healing and infection caused by residual bone voids. CERAMENT|BVF is commercially available in the U.S., EU, S.E. Asia and the Middle East.

CERAMENT's distinctive properties as a drug eluting material have been validated in clinical practice by CERAMENT™|G and CERAMENT™ V, the first CE-marked injectable antibiotic eluting bone graft substitutes. These products provide local sustained delivery of gentamicin and vancomycin, respectively. The local delivery feature enables an initial high concentration of antibiotics to the bone defect and then a longer sustainable dose above the minimal inhibitory concentration (MIC) to protect bone healing and promote bone remodeling.

CERAMENT|G and CERAMENT™ have demonstrated good results in patients with problematic bone infections including osteomyelitis. They are also used prophylactically in patients who are at risk for developing infection. CERAMENT|G and CERAMENT™ V are available in the EU.

BONESUPPORT AB was founded in 1999 by Prof. Lars Lidgren, an internationally respected scientist who has been the President of various musculoskeletal societies. BONESUPPORT’s mission is to bring people with bone and joint diseases back to an active life. The company is based in Lund, Sweden.

bonesupport.com

BONESUPPORT™ is a registered trademark.

Contact Information

Citigate Dewe Rogerson

David Dible, Andrea Bici, Mark Swallow

+44 (0)20 7282 2949/1050/2948

Downloads

Press release PDF (105.19 KB)

BONESUPPORT highlights significant strategic progress at Capital Market Days in Stockholm and London

19th September 2018

BONESUPPORT highlights significant strategic progress at Capital Market Days in Stockholm and London

Lund, Sweden, 08:00 CET, 19 September 2018

  • Strategic review has led to important initiatives to strengthen BONESUPPORT’s US and European commercial platforms
  • Excellent progress in creating own distributor network in the US.
    • 18 new distributors contracted.
    •  425 highly motivated sales reps to sell BONESUPPORT’s products from 21 October 2018
  • European commercial expansion on track
    • 7 skilled sales reps hired to better penetrate major markets such as Germany.
    • Accelerate push into major indications such as trauma
  • FORTIFY study patient recruitment on track
    • Data designed to support a planned PMA filing with FDA in the US for CERAMENT G in 2020
  • CERTiFy study results expected to be published early 2019
    • Positive data could allow CERAMENT products to gain market shares from autograft 
  • Sales outlook
    • We expect these growth initiatives to lead to strong growth 2019 and a CAGR following 2019 of +40% 

 

BONESUPPORT, an emerging leader in orthobiologics for the management of bone voids, will highlight the significant progress made executing its updated Corporate Strategy at Capital Markets Days it is hosting in Stockholm today and in London tomorrow.

BONESUPPORT evolved strategy is focused on 3 areas:

  • Innovation
  • Strong clinical evidence and HEOR data
  • Effective commercial platform

 

The Company has a strong management team and strong financial position to enable it to successfully execute its strategy.

Emil Billbäck, BONESUPPORT’s CEO said “The Strategic Review identified a clear need to considerably optimize and strengthen our commercial platform to capture the significant potential of our CERAMENT® products. We have made excellent progress in building a US distributor network and commercial organization ahead of commencing to sell CERAMENT BVF direct on 21 October. In Europe, we have added skilled sales people to increase penetration of major indications such as trauma. I am very pleased that we have a clear focused strategy to guide us for the next five years and that we are creating the commercial platform to accelerate market penetration of our CERAMENT products.”

 

INNOVATION

Unique Product Offering

Innovation has been central to the development of BONESUPPORT’s current unique product offering of synthetic bone graft substitutes. The Company is investing to ensure that it continues to have a highly differentiated product offering.

In the short and mid-term, BONESUPPORT is augmenting the products that it develops in-house by acquiring products or product licenses to enable it to offer innovative treatment solutions that complement its CERAMENT portfolio. BONESUPPORT is also progressing its long-term innovative product portfolio focused on enhancing bone growth.

 

BONESUPPORT expects to introduce new products regularly in the years ahead, including:

-          New combination products based on CERAMENT

-          CERAMENT procedural kits

-          Acquired or in-licensed products, that will expand and add value to our overall offering

 

The Company has made good progress with this strategy in 2018, signing important strategic deals with Collagen Matrix and MTF Biologics. These deals will enable BONESUPPORT to expand its US product offering in 2019 and to develop selected new combination products, mid-term.

 

STRONG CLINICAL EVIDENCE AND HEALTH ECONOMIC DATA

Industry leading data base

BONESUPPORT already has the industry’s leading clinical and pre-clinical data base comprising over 150 publications/abstracts.

To further strengthen the clinical data supporting its key products the Company is conducting two large level 1 clinical studies:

-          CERTiFy, which compares the differences in pain, quality of life, and cost of care in the treatment of tibia plateau fracture-associated bone defects using either CERAMENT BVF or autograft  

-          FORTIFY, which is evaluating the safety and efficacy of CERAMENT G as part of surgical repair of open diaphyseal tibial fractures versus standard of care.

 

In the CERTiFy study, the recruitment of the planned 136 patients into the trial was completed at the end of 2018. This study is designed to generate randomized clinical data comparing CERAMENT BVF with autograft, the most widely used approach for the management of bone voids today.

Positive data from this study could lead to a significant change in the standard of care of the management of patients with trauma associated bone defects. First result data from the CERTiFy study will be available by the end of 2018 and publication is expected at the beginning of 2019.

BONESUPPORT’s most important study, FORTIFY, which is designed to support a planned PMA filing with FDA in the US for CERAMENT G in 2020 remains on track to complete patient recruitment in 2019. A successful outcome to this study and the potential approval for CERAMENT G could open up the opportunity for surgeons to use this novel antibiotic-eluting synthetic bone void filler to treat complex trauma patients at risk of developing a bone infection.

 

EFFECTIVE COMMERCIAL PLATFORM

Expanding our US and European Commercial Platforms

 

US

The Company has taken the very important decision to build its own network of independent distributors in the US. The main reasons for the decision are

-          Gaining control of our business in the US, the world’s largest orthopedic market

-          Access to a much larger market opportunity

-          Higher net margins

-          Increased ability to drive sales

-          Ability to expand the portfolio offering

-          Ability to invest ahead of the CERAMENT G launch

 

BONESUPPORT terminated its exclusive distribution agreement for CERAMENT BVF with Zimmer Biomet (ZB) for the US market in May 2018. Under the terms of this agreement, ZBs exclusivity expires on 20 October 2018.  BONESUPPORT has already contracted 18 high quality distributors that together employ a total of 425 sales reps. This stronger and new commercial platform will be ready to sell and distribute CERAMENT BVF from 21st October 2018. This enhanced distribution network will be supported by the Company’s expanded in-house commercial team. The new commercial organization will approach the key US purchasing organizations to ensure that CERAMENT have access to a larger number of hospitals.

 

Europe
The Company is currently in the process of almost doubling its sales team in the five key European markets with a direct sales organization. This investment is designed to increase the uptake of our products, with focus on the antibiotic-eluting products CERAMENT G and V, for major indications such as complex trauma where there is a clear opportunity to drive sales growth. We have recruited 7 high quality, experienced sales people out of the 13 that we communicated we would hire in 2018. The majority is deployed in Germany, which is a major market for BONESUPPORT.

 

SALES OUTLOOK

We expect these initiatives, in the US and Europe, to lead to strong growth for BONESUPPORT in 2019 and a CAGR following 2019 of +40%.

BONEUPPORT will provide more details on the key elements of its strategy , outlined in this press release, at its Capital Markets Days that will be held today in Stockholm and tomorrow in London.  Speakers at these events from BONESUPPORT’s Executive Management Team will be CEO Emil Billbäck, CFO Björn Westberg, Dr Michael Diefenbeck, Head of R&D, Medical and Clinical Affairs and Patrick O’ Donnell, Executive Vice President Commercial Operations North America.

The Capital Market Days will also include presentations on the clinical use of CERAMENT products from:

  • Anders Jönsson, Senior Consultant Orthopedic Surgeon at Sahlgrenska University Hospital at the Stockholm event and
  • Professor Venu Kavarthapu, Senior Consultant Surgeon at Kings College Hospital, London at the London event

 

The Capital Markets Day in Stockholm will be recorded via a webcast and presented on-line, further information on the event is available on the Company’s website www.bonesupport.com, link: https://www.bonesupport.com/en-eu/events-investorsp/

 

About BONESUPPORT

BONESUPPORT is an innovative commercial stage orthobiologics company, based in Lund, Sweden. The Company develops and commercializes innovative injectable bio-ceramic bone graft substitutes that remodel to the patient’s own bone and have the capability of eluting drugs directly into the bone void.

BONESUPPORT’s bio-ceramic bone graft substitutes CERAMENT® BONE VOID FILLER (BVF), CERAMENT® G* and CERAMENT® V* are all based on the Company’s novel and proprietary technology platform.

The Company’s products are targeting a large addressable market opportunity across trauma, chronic osteomyelitis (bone infection), revision arthroplasty (replacement of a joint prosthesis), ortho-oncology, foot and ankle, and infected diabetic foot.

BONESUPPORT’s total sales increased from SEK 62 million in 2015 to SEK 129 million in 2017, representing a compound annual growth rate of 45%.

The Company’s research and development is focused on the continuing development and refinement of its CERAMENT technology to extend its use into additional indications by the elution of drugs and therapeutic agents. The Company currently has a pipeline of pre-clinical product candidates that have been designed to promote bone growth.

In addition, BONESUPPORT is looking to expand its product offering in the US and has entered into a strategic agreement with MTF Biologics and Collagen Matrix Inc. to market and distribute products that are complementary to CERAMENT BVF.

BONESUPPORT is listed on Nasdaq Stockholm and trades under the ticker “BONEX” (ISIN code: SE0009858152). Further information is available at www.bonesupport.com

*CERAMENT G: Not available in the United States, for investigational use only.

  CERAMENT V: Not available in the United States.

BONESUPPORT and CERAMENT® are registered trademarks.

For more information contact:

 

BONESUPPORT AB

Emil Billbäck, CEO

+46 (0) 46 286 53 70

 

Björn Westberg, CFO

+46 (0) 46 286 53 60

ir@bonesupport.com

 

Citigate Dewe Rogerson

Pip Batty, David Dible, Shabnam Bashir

+44 (0)20 7282 1022

bonesupport@citigatedewerogerson.com

 

This information is such information as BONESUPPORT HOLDING AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 08.00 CET on 19 September 2018.

Downloads

Press release PDF (282.34 KB)

BONESUPPORT to be Featured at the Annual Meeting of the European Bone & Joint Infection Society (EBJIS)

6th September 2018

BONESUPPORT to be Featured at the Annual Meeting of the European Bone & Joint Infection Society (EBJIS)

Lund, Sweden, 07:30 CET, 6 September 2018 - BONESUPPORT, an emerging leader in orthobiologics for the management of bone voids, announces that abstracts detailing clinical research using the Company’s CERAMENT platform will feature prominently at the 37th Meeting of the European Bone & Joint Infection Society (EBJIS), which this year takes place on 6th September in Helsinki, Finland. EBJIS is the key European congress for physicians and surgeons managing patients with bone infections.

 

The EBJIS annual meeting will feature 11 abstracts highlighting research and clinical findings with CERAMENT® G and CERAMENT® V in indications such as trauma, chronic osteomyelitis and diabetic foot.

BONESUPPORT is a Platinum Sponsor of the event and will host a company-sponsored symposium with presentations from Oxford University Hospitals (Martin McNally and Jamie Ferguson) and University Hospitals Leuven (Willem-Jan Metsemakers).

 

Emil Billbäck, CEO of BONESUPPORT, said: “The research and clinical data to be presented highlights the increasing interest and use of CERAMENT G and V based on the unrivalled benefits they deliver to patients and orthopedic surgeons. It is an exciting time for BONESUPPORT with CERAMENT G recently having been approved for use by Health Canada.”

CERAMENT G and CERAMENT V are the only CE-marked injectable antibiotic eluting bone graft substitutes which provide local sustained delivery of gentamicin and vancomycin, respectively.

Both CERAMENT G and CERAMENT V are able to deliver an initial high concentration of antibiotic to the bone defect and then a longer sustainable dose above the minimal inhibitory concentration (MIC) to promote and protect bone healing and remodeling. 

The Company is currently conducting the FORTIFY clinical trial to assess CERAMENT G’s ability to improve on the standard-of-care management of patients with open tibia fractures. The primary endpoints of the trial include the absence of deep infection at the fracture site and the lack of secondary procedures intended to promote fracture union.  The trial will also evaluate the safety of CERAMENT G. The trial will enroll up to 230 patients at up to 30 centers in the US and Europe.

 

Positive data from the FORTIFY trial will be used to support BONESUPPORT’s PMA (Premarket Approval) filing for CERAMENT G in the US, where the product is expected to be launched in 2021.

 

About BONESUPPORT

BONESUPPORT is an innovative and rapidly growing commercial stage orthobiologics company, based in Lund, Sweden. The Company develops and commercializes innovative injectable bio-ceramic bone graft substitutes that remodel to the patient’s own bone and have the capability of eluting drugs directly into the bone void.

BONESUPPORT’s bio-ceramic bone graft substitutes CERAMENT® BONE VOID FILLER (BVF), CERAMENT® G* and CERAMENT® V* are all based on the Company’s novel and proprietary technology platform.

The Company’s products are targeting a large addressable market opportunity across trauma, chronic osteomyelitis (bone infection), revision arthroplasty (replacement of a joint prosthesis), ortho-oncology, foot and ankle, and infected diabetic foot.

BONESUPPORT’s total sales increased from SEK 62 million in 2015 to SEK 129 million in 2017, representing a compound annual growth rate of 45%.

The Company’s research and development is focused on the continuing development and refinement of its CERAMENT technology to extend its use into additional indications by the elution of drugs and therapeutic agents. The Company currently has a pipeline of pre-clinical product candidates that have been designed to promote bone growth.

In addition, BONESUPPORT is looking at opportunities to expand its product offering in the US and has entered into a strategic agreement with MTF Biologics and Collagen Matrix Inc. to market and distribute products that are complementary to CERAMENT BVF.

BONESUPPORT is listed on Nasdaq Stockholm and trades under the ticker “BONEX” (ISIN code: SE0009858152). Further information is available at www.bonesupport.com

*CERAMENT G: Not available in the United States, for investigational use only.
  CERAMENT V: Not available in the United States.

BONESUPPORT and CERAMENT® are registered trademarks.

 

For more information contact:

BONESUPPORT AB

Emil Billbäck, CEO

+46 (0) 46 286 53 70

 

Björn Westberg, CFO

+46 (0) 46 286 53 60

ir@bonesupport.com

 

Citigate Dewe Rogerson

Pip Batty, David Dible, Shabnam Bashir

+44 (0)20 7282 1022

bonesupport@citigatedewerogerson.com

 

This information is such information as BONESUPPORT HOLDING AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 07.30 CET on 6 September 2018.

Downloads

Press release PDF (240.88 KB)

Invitation BONESUPPORT Capital Markets Days

5th September 2018

Invitation BONESUPPORT Capital Markets Days

Lund, Sweden, 15:00 CET, 5 September 2018 - BONESUPPORT, an emerging leader in orthobiologics for the management of bone voids, invite journalists, analysts and investors to its Capital Markets Days in Stockholm and London.

 19 September 2018 at 9:00am – 12.00pm Stockholm 
(IVA Conference Center -Wennström-salen -Grev Turegatan 16)
 
20 September 2018 at 9:30am – 12.30pm London
(Citigate Dewe Rogerson, 3 London Wall Buildings, London Wall, London EC2M 5SY) 

Speakers at the events from BONESUPPORT’s Executive Management Team will be Emil Billbäck CEO, Björn Westberg CFO, Dr Michael Diefenbeck, Head of R&D, Medical and Clinical Affairs and Patrick O’ Donnell, Executive Vice President Commercial Operations North America. The Capital Market Days will also include a presentation on CERAMENT in clinical application in Stockholm by Anders Jönsson, Senior Consultant Orthopedic Surgeon at Sahlgrenska University Hospital and in London by Professor Venu Kavarthapu, Senior Consultant Surgeon at Kings College Hospital, London.

 

The agenda* is as follows:

Sep 19 Stockholm

Sep 20 London

 

09.00

09.30

Introduction

 

 

The CERAMENT platform

 

 

CERAMENT in clinical application

 

 

Market Opportunity

 

 

Q&A

10.05-10.20

10.35-10.50

Coffee break

10.20

10.50

Strategy

 

 

Product innovation

 

 

Generating clinical data

 

 

Our HEOR activities

 

 

EUROW Commercial platform

 

 

US Commercial platform

11.30

12.00

Financial overview

 

 

Wrap up

 

 

Q&A

 

  • Subject to change

 

The Capital Markets Days will be held in English. Further information will be available on the Company’s website prior to the event. Please register by using this link https://www.bonesupport.com/en-eu/calendar/ by 14 September. The event in Stockholm will be led by Charlotte Stjerngren. The event will  be webcasted. More information will be available via the same link prior to the webcast.

 

About BONESUPPORT

BONESUPPORT is an innovative commercial stage orthobiologics company, based in Lund, Sweden. The Company develops and commercializes innovative injectable bio-ceramic bone graft substitutes that remodel to the patient’s own bone and have the capability of eluting drugs directly into the bone void.

BONESUPPORT’s bio-ceramic bone graft substitutes CERAMENT® BONE VOID FILLER (BVF), CERAMENT® G* and CERAMENT® V* are all based on the Company’s novel and proprietary technology platform.

The Company’s products are targeting a large addressable market opportunity across trauma, chronic osteomyelitis (bone infection), revision arthroplasty (replacement of a joint prosthesis), ortho-oncology, foot and ankle, and infected diabetic foot.

BONESUPPORT’s total sales increased from SEK 62 million in 2015 to SEK 129 million in 2017, representing a compound annual growth rate of 45%.

The Company’s research and development is focused on the continuing development and refinement of its CERAMENT technology to extend its use into additional indications by the elution of drugs and therapeutic agents. The Company currently has a pipeline of pre-clinical product candidates that have been designed to promote bone growth.

In addition, BONESUPPORT is looking to expand its product offering in the US and has entered into a strategic agreement with MTF Biologics and Collagen Matrix Inc. to market and distribute products that are complementary to CERAMENT BVF.

BONESUPPORT is listed on Nasdaq Stockholm and trades under the ticker “BONEX” (ISIN code: SE0009858152). Further information is available at www.bonesupport.com

*CERAMENT G: Not available in the United States, for investigational use only.
  CERAMENT V: Not available in the United States.

BONESUPPORT and CERAMENT® are registered trademarks.

For more information contact:

 

BONESUPPORT AB

Emil Billbäck, CEO

+46 (0) 46 286 53 70

 

Björn Westberg, CFO

+46 (0) 46 286 53 60

ir@bonesupport.com

 

Citigate Dewe Rogerson

Pip Batty, David Dible, Shabnam Bashir

+44 (0)20 7282 1022

bonesupport@citigatedewerogerson.com

 

The information was submitted for publication, through the agency of the contact person set out above, at 15.00 CET on 5 September 2018.

Downloads

Press release PDF (252.24 KB)

Save the date: BONESUPPORT Capital Markets Days to be held in Stockholm and London

24th August 2018

Save the date: BONESUPPORT Capital Markets Days to be held in Stockholm and London

Lund, Sweden, 11:00 CET, 24 August 2018 - BONESUPPORT, an emerging leader in orthobiologics for the management of bone voids, invites analysts and investors to its Capital Markets Days to take place in Stockholm and London.

Capital Markets Days:

19 September 2018 at 9:00am – 12.00 pm Stockholm (IVA Conference Center (Wennstrm-salen) Grev Turegatan 16)
20 September 2018 at 9:30am – 12.30 pm London (Citigate Office 3 London Wall)

 

Speakers at the events from BONESUPPORT’s Executive Management Team will be CEO Emil Billbäck, CFO Björn Westberg, Dr Michael Diefenbeck, Head of R&D, Medical and Clinical Affairs and Patrick O’ Donnell, Executive Vice President Commercial Operations North America.

A formal invitation with a complete agenda will be sent out around two weeks before the meetings. The Capital Markets Day will be held in English. Further information will be available on the Company’s website www.bonesupport.com prior to the event.

 

About BONESUPPORT

BONESUPPORT is an innovative and rapidly growing commercial stage orthobiologics company, based in Lund, Sweden. The Company develops and commercializes innovative injectable bio-ceramic bone graft substitutes that remodel to the patient’s own bone and have the capability of eluting drugs directly into the bone void.

BONESUPPORT’s bio-ceramic bone graft substitutes CERAMENT® BONE VOID FILLER (BVF), CERAMENT® G* and CERAMENT® V* are all based on the Company’s novel and proprietary technology platform.

The Company’s products are targeting a large addressable market opportunity across trauma, chronic osteomyelitis (bone infection), revision arthroplasty (replacement of a joint prosthesis), ortho-oncology, foot and ankle, and infected diabetic foot.

BONESUPPORT’s total sales increased from SEK 62 million in 2015 to SEK 129 million in 2017, representing a compound annual growth rate of 45%.

The Company’s research and development is focused on the continuing development and refinement of its CERAMENT technology to extend its use into additional indications by the elution of drugs and therapeutic agents. The Company currently has a pipeline of pre-clinical product candidates that have been designed to promote bone growth.

In addition, BONESUPPORT is looking at opportunities to expand its product offering in the US and has entered into a strategic agreement with MTF Biologics and Collagen Matrix Inc. to market and distribute products that are complementary to CERAMENT BVF.

BONESUPPORT is listed on Nasdaq Stockholm and trades under the ticker “BONEX” (ISIN code: SE0009858152). Further information is available at www.bonesupport.com

*CERAMENT G: Not available in the United States, for investigational use only.
  CERAMENT V: Not available in the United States.

BONESUPPORT and CERAMENT® are registered trademarks.

For more information contact:

 

BONESUPPORT AB

Emil Billbäck, CEO

+46 (0) 46 286 53 70

Björn Westberg, CFO

+46 (0) 46 286 53 60

ir@bonesupport.com

 

Citigate Dewe Rogerson

Pip Batty, David Dible, Shabnam Bashir

+44 (0)20 7282 1022

bonesupport@citigatedewerogerson.com

 

This information is such information as BONESUPPORT HOLDING AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 18.00 CET on 16 August 2018.

Downloads

Press release PDF (230.49 KB)

BONESUPPORT - CERAMENT® G Approved by Health Canada

16th August 2018

BONESUPPORT - CERAMENT® G Approved by Health Canada

Lund, Sweden, 18:00 CET, 16 August 2018 - BONESUPPORT, an emerging leader in orthobiologics for the management of bone voids, announces that its antibiotic-eluting product CERAMENT G has been approved by Health Canada.

CERAMENT G is the first and only CE-marked gentamicin-eluting injectable ceramic bone graft substitute on the market.  CERAMENT G sales have been growing strongly based on the clinical benefits it delivers when used for indications where infection may be present or of concern.

BONESUPPORT is currently conducting the FORTIFY trial to assess CERAMENT G’s ability to improve on the standard-of-care management of patients with open fractures of the tibial diaphysis. The primary endpoints of the trial  include the absence of deep infection at the fracture site and the lack of secondary procedures intended to promote fracture union.  The trial will also evaluate the safety of CERAMENT G in these patients. The trial will enroll up to 230 patients at up to 30 centers in the US and Europe.

Positive data from the FORTIFY trial will be used to support BONESUPPORT’s PMA (Premarket Approval) filing for CERAMENT G   in the US, where the product is expected to be launched in 2021.

Emil Billbäck, CEO of BONESUPPORT said: “We are looking forward to commercializing CERAMENT G in Canada following its approval by Health Canada. CERAMENT G will be the first injectable antibiotic eluting ceramic bone graft substitute to be launched on the Canadian market. We are currently in dialogue with potential distributors to assist us in bringing this novel product to orthopedic surgeons managing bone voids where infection is present or an important risk.”

 

About BONESUPPORT

BONESUPPORT is an innovative and rapidly growing commercial stage orthobiologics company, based in Lund, Sweden. The Company develops and commercializes innovative injectable bio-ceramic bone graft substitutes that remodel to the patient’s own bone and have the capability of eluting drugs directly into the bone void.

BONESUPPORT’s bio-ceramic bone graft substitutes CERAMENT® BONE VOID FILLER (BVF), CERAMENT® G* and CERAMENT® V* are all based on the Company’s novel and proprietary technology platform.

The Company’s products are targeting a large addressable market opportunity across trauma, chronic osteomyelitis (bone infection), revision arthroplasty (replacement of a joint prosthesis), ortho-oncology, foot and ankle, and infected diabetic foot.

BONESUPPORT’s total sales increased from SEK 62 million in 2015 to SEK 129 million in 2017, representing a compound annual growth rate of 45%.

The Company’s research and development is focused on the continuing development and refinement of its CERAMENT technology to extend its use into additional indications by the elution of drugs and therapeutic agents. The Company currently has a pipeline of pre-clinical product candidates that have been designed to promote bone growth.

In addition, BONESUPPORT is looking at opportunities to expand its product offering in the US and has entered into a strategic agreement with MTF Biologics and Collagen Matrix Inc. to market and distribute products that are complementary to CERAMENT BVF.

BONESUPPORT is listed on Nasdaq Stockholm and trades under the ticker “BONEX” (ISIN code: SE0009858152). Further information is available at www.bonesupport.com

*CERAMENT G: Not available in the United States, for investigational use only.
  CERAMENT V: Not available in the United States.

BONESUPPORT and CERAMENT® are registered trademarks.

For more information contact:

 

BONESUPPORT AB

Emil Billbäck, CEO

+46 (0) 46 286 53 70

Björn Westberg, CFO

+46 (0) 46 286 53 60

ir@bonesupport.com

 

Citigate Dewe Rogerson

Pip Batty, David Dible, Shabnam Bashir

+44 (0)20 7282 1022

bonesupport@citigatedewerogerson.com

 

This information is such information as BONESUPPORT HOLDING AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 18.00 CET on 16 August 2018.

Downloads

Press release PDF (221 KB)

BONESUPPORT Signs Agreement with MTF Biologics to Expand US Product Offering

2nd August 2018

BONESUPPORT Signs Agreement with MTF Biologics to Expand US Product Offering

Lund, Sweden, 08:00 CET, 2 August 2018 - BONESUPPORT, an emerging leader in orthobiologics for the management of bone voids, has signed an agreement with MTF Biologics, the world’s largest tissue bank, to extend and strengthen its US product offering.

The agreement will give BONESUPPORT US rights to two forms of bone graft materials comprised of 100% demineralized bone matrix (DBM), which offer improved osteoinductivity when compared to many other DBM products. These products, which are both osteoinductive and osteoconductive, complement CERAMENT BVF (osteoconductive) and the products gained from the Company’s recent strategic agreement with Collagen Matrix Inc. (osteoinductive and osteogenic)

BONESUPPORT plans to launch the products supplied by MTF Biologics under the BONESUPPORT brand name and through its own US distribution network.

MTF Biologics is a non-profit service organization dedicated to providing clinically sound, safe allograft tissue. MTF Biologics is comprised of a national consortium of academic medical institutions, organ procurement organizations and tissue recovery organizations. It is based in Edison, NJ, USA.

Emil Billbäck, CEO of BONESUPPORT said, “Today’s deal with MTF Biologics is a further important step in creating the broad and complementary US product offering that will address the needs of orthopedic surgeons managing bone voids. We are pleased that MTF Biologics, the world’s leading tissue bank, has chosen to partner with BONESUPPORT, and we look forward to marketing products based on their high-quality demineralized bone matrix. With our expanded product portfolio and new broad US distribution channel, that we are on track to have in place in late October, we are well placed to significantly improve our competitive position and rapidly grow sales ahead of the planned US launch of CERAMENT G in 2021.”

“MTF Biologics is pleased to be partnering with BONESUPPORT on the promotion of our demineralized bone matrix fiber technology. We are excited for this opportunity to work together to deliver biologic solutions that serve the needs of surgeons and their patients.” said Tom Shaffer, MTF Biologics EVP, Global Sales & Marketing.

 

About MTF Biologics

MTF Biologics is a nonprofit organization based in Edison, N.J. It is a national consortium comprised of leading organ procurement organizations, tissue recovery organization and academic medical institutions, and governed by a board of surgeons who are leading experts in tissue transplantation. As the world's largest tissue bank, MTF Biologics saves and heals lives by honoring donated gifts, serving patients and advancing science. Since its inception in 1987, the organization has received tissue from more than 120,000 donors and distributed more than 7.5 million allografts for transplantation. Through its IIAM subsidiary, it has placed more than 55,000 non-transplantable organs for research. Through its Statline subsidiary, it has managed more than 10 million donor referrals.

For more information, visit www.mtf.org

 

About BONESUPPORT

BONESUPPORT is an innovative and rapidly growing commercial stage orthobiologics company, based in Lund, Sweden. The Company develops and commercializes innovative injectable bio-ceramic bone graft substitutes that remodel to the patient’s own bone and have the capability of eluting drugs directly into the bone void.

BONESUPPORT’s bio-ceramic bone graft substitutes CERAMENT® BONE VOID FILLER (BVF), CERAMENT® G* and CERAMENT® V* are all based on the Company’s novel and proprietary technology platform.

The Company’s products are targeting a large addressable market opportunity across trauma, chronic osteomyelitis (bone infection), revision arthroplasty (replacement of a joint prosthesis) and infected diabetic foot.

BONESUPPORT’s total sales increased from SEK 62 million in 2015 to SEK 129 million in 2017, representing a compound annual growth rate of 45%.

The Company’s research and development is focused on the continuing development and refinement of its CERAMENT technology to extend its use into additional indications by the elution of drugs and therapeutic agents. The Company currently has a pipeline of pre-clinical product candidates that have been designed to promote bone growth.

In addition, BONESUPPORT is looking to expand its product offering in the US and has entered into strategic agreements with Collagen Matrix Inc. and MTF Biologics to market and distribute products that are complementary to CERAMENT BVF.

BONESUPPORT is listed on Nasdaq Stockholm and trades under the ticker “BONEX” (ISIN code: SE0009858152). Further information is available at www.bonesupport.com

*CERAMENT G: Not available in the United States, for investigational use only.
  CERAMENT V: Not available in the United States.

BONESUPPORT and CERAMENT® are registered trademarks.

 

For more information contact:

 

Emil Billbäck, CEO

+46 (0) 46 286 53 70

 

Björn Westberg, CFO

+46 (0) 46 286 53 60

ir@bonesupport.com

 

Citigate Dewe Rogerson

Pip Batty, David Dible, Shabnam Bashir

+44 (0)20 7282 1022

bonesupport@citigatedewerogerson.com

This information is such information as BONESUPPORT HOLDING AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 08.00 CET on 2 August 2018.

Downloads

Press release PDF (134.89 KB)

BONESUPPORT HOLDING AB (publ) – Interim Report

26th July 2018

BONESUPPORT HOLDING AB (publ) – Interim Report

January – June 2018

Lund, Sweden, 08.00 CET, 26 July 2018 – BONESUPPORT, an emerging leader in orthobiologics for the management of bone voids, today announces the publication of its Q2 and Half-year Interim Report.

STRATEGIC DECISIONS IN THE QUARTER TO DRIVE FUTURE GROWTH

FINANCIAL HIGHLIGHTS

1 APRIL –  30 JUNE 2018

  • Net Sales amounted to SEK 28.2 million (37.1), a decrease of 24%, mainly due to our termination of the US distribution agreement with Zimmer Biomet in May
  • Gross margin of 87.4% (87.2)
  • Operating loss of SEK -37.8 million (-18.4)
  • Earnings per share before and after dilution was SEK -0.75 (-0.76)

1 JANUARY – 30 JUNE 2018

  • Net Sales amounted to SEK 59.3 million (69.6), a decrease of 15%, in which the North America segment decreased by 32% and the segment Europe and Rest of World increased by 15%
  • Gross margin of 84.6% (88.0)
  • Operating loss of SEK -70.9 million (-45.8)
  • Earnings per share before and after dilution was SEK -1.42 (-1.82)

 

BUSINESS HIGHLIGHTS

1 APRIL – 30 JUNE 2018

  • BONESUPPORT is building its own commercial distribution structure in US, and terminated current distribution agreement
  • Zimmer Biomet cancelled most orders for Jun-Aug due to termination of contract
  • Strategic agreement signed with Collagen Matrix Inc. to sell several of their products containing natural and synthetic bone material
  • Decision to significantly expand the commercial organisation in Europe during 2018
  • General Annual Meeting resolved share-based incentive programs
  • General Annual Meeting appointed Simon Cartmell as new Board member

AFTER PERIOD END

  • Håkan Johansson appointed to replace Björn Westberg as CFO during the autumn
  • Michael Diefenbeck, Chief Medical Officer, took over the responsibility for R&D and Clinical Affairs from Jerry Chang on July 18

“In the quarter several significant strategic decisions were taken, including creating a new distribution structure in the US, accessing complementary products through in-licensing and almost doubling of our European sales force, which should create opportunities for increased market penetration in the years ahead.” Emil Billbäck, CEO


 

The full Report is available by clicking on the links below:

Outside the US: https://www.bonesupport.com/en-eu/financial-reports/

US: https://www.bonesupport.com/en-us/financial-reports-us23/

 

Conference Call/Webcast Details

The Company will host a conference call and an online presentation at 14.00 CET today.

The dial-in numbers for the conference call are:

UK: +44 2030089809

SE: +46 856642665

US: +1 8558315945

 

Webcast

The presentation will also be webcast and can be accessed from the following web address:

https://financialhearings.com/event/10858The dial-in numbers for the conference call are:

UK: +442030089806

SE: +46850639549

US: +18558315945

The presentation will also be webcast and can be accessed from the following web address:

http://www.financialhearings.com/event/10531

The dial-in numbers for the conference call are:

UK: +442030089806

SE: +46850639549

US: +18558315945

The presentation will also be webcast and can be accessed from the following web address:

http://www.financialhearings.com/event/10531

The dial-in numbers for the conference call are:

UK: +442030089806

SE: +46850639549

US: +18558315945

The presentation will also be webcast and can be accessed from the following web address:

http://www.financialhearings.com/event/10531

 

Hosts: Emil Billbäck, CEO, and Björn Westberg, CFO

 

Conference Call/Webcast Details

The Company will host a conference call and an online presentation at 14.00 CET today.

The dial-in numbers for the conference call are:

UK: +44 2030089809

SE: +46 856642665

US: +1 8558315945

 

Webcast

The presentation will also be webcast and can be accessed from the following web address:

https://financialhearings.com/event/10858The dial-in numbers for the conference call are:

UK: +442030089806

SE: +46850639549

US: +18558315945

The presentation will also be webcast and can be accessed from the following web address:

http://www.financialhearings.com/event/10531

The dial-in numbers for the conference call are:

UK: +442030089806

SE: +46850639549

US: +18558315945

The presentation will also be webcast and can be accessed from the following web address:

http://www.financialhearings.com/event/10531

The dial-in numbers for the conference call are:

UK: +442030089806

SE: +46850639549

US: +18558315945

The presentation will also be webcast and can be accessed from the following web address:

http://www.financialhearings.com/event/10531

Hosts: Emil Billbäck, CEO, and Björn Westberg, CFO

 

 

About BONESUPPORT

BONESUPPORT is an innovative and rapidly growing commercial stage orthobiologics company, based in Lund, Sweden. The Company develops and commercializes innovative injectable bio-ceramic bone graft substitutes that remodel to the patient’s own bone and have the capability of eluting drugs directly into the bone void.

BONESUPPORT’s bio-ceramic bone graft substitutes CERAMENT® BONE VOID FILLER (BVF), CERAMENT® G* and CERAMENT® V* are all based on the Company’s novel and proprietary technology platform.

The Company’s products are targeting a large addressable market opportunity across trauma, chronic osteomyelitis (bone infection), revision arthroplasty (replacement of a joint prosthesis) and infected diabetic foot.

BONESUPPORT’s total sales increased from SEK 62 million in 2015 to SEK 129 million in 2017, representing a compound annual growth rate of 45%.

The Company’s research and development is focused on the continuing development and refinement of its CERAMENT technology to extend its use into additional indications by the elution of drugs and therapeutic agents. The Company currently has a pipeline of pre-clinical product candidates that have been designed to promote bone growth.

In addition, BONESUPPORT is looking at opportunities to expand its product offering in the US and has entered into a strategic agreement with Collagen Matrix Inc. to market and distribute products that are complementary to CERAMENT BVF.

BONESUPPORT is listed on Nasdaq Stockholm and trades under the ticker “BONEX” (ISIN code: SE0009858152). Further information is available at www.bonesupport.com

*CERAMENT G: Not available in the United States, for investigational use only.

  CERAMENT V: Not available in the United States.

BONESUPPORT and CERAMENT® are registered trademarks.

 

For more information contact:

Emil Billbäck, CEO

+46 (0) 46 286 53 70

Björn Westberg, CFO

+46 (0) 46 286 53 60

ir@bonesupport.com

 

Citigate Dewe Rogerson

Pip Batty, David Dible, Shabnam Bashir, Isabelle Andrews

+44 (0)20 7282 1022

bonesupport@citigatedewerogerson.com

 

This information is such information as BONESUPPORT HOLDING AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 08.00am CET on 26 July 2018.

 

Downloads

Press release PDF (315.84 KB)

Q2 2018 Interim Report – invitation to conference call and webcast

23rd July 2018

Q2 2018 Interim Report – invitation to conference call and webcast

Lund, Sweden, 13.00 CET, 23 July 2018 – BONESUPPORT, an emerging leader in orthobiologics for the management of bone voids will publish its Q2 2018 Interim Report on Thursday 26 July 2018 at 8am CET.

The Company will also host a conference call and an online presentation on the same day at 2pm CET.

The dial-in numbers for the conference call are: UK: +44 2030089809

SE: +46 856642665

US: +1 8558315945

 

The presentation will also be webcast and can be accessed from the following web address: https://financialhearings.com/event/10858

 

Hosts: Emil Billbäck, CEO, and Björn Westberg, CFO

 

About BONESUPPORT

BONESUPPORT is an innovative and rapidly growing commercial stage orthobiologics company, based in Lund, Sweden. The Company develops and commercializes innovative injectable bio-ceramic bone graft substitutes that remodel to the patient’s own bone and have the capability of eluting drugs directly into the bone void.

BONESUPPORT’s bio-ceramic bone graft substitutes CERAMENT® BONE VOID FILLER (BVF), CERAMENT® G* and CERAMENT® V* are all based on the Company’s novel and proprietary technology platform.

The Company’s products are targeting a large addressable market opportunity across trauma, chronic osteomyelitis (bone infection), revision arthroplasty (replacement of a joint prosthesis) and infected diabetic foot.

BONESUPPORT’s total sales increased from SEK 62 million in 2015 to SEK 129 million in 2017, representing a compound annual growth rate of 45%.

The Company’s research and development is focused on the continuing development and refinement of its CERAMENT technology to extend its use into additional indications by the elution of drugs and therapeutic agents. The Company currently has a pipeline of pre-clinical product candidates that have been designed to promote bone growth.

 

In addition, BONESUPPORT is looking at opportunities to expand its product offering in the US and has entered into a strategic agreement with Collagen Matrix Inc. to market and distribute products that are complementary to CERAMENT BVF.

BONESUPPORT is listed on Nasdaq Stockholm and trades under the ticker “BONEX” (ISIN code: SE0009858152). Further information is available at www.bonesupport.com

*CERAMENT G: Not available in the United States, for investigational use only.
  CERAMENT V: Not available in the United States.

BONESUPPORT and CERAMENT® are registered trademarks.

For more information contact:

Emil Billbäck, CEO

+46 (0) 46 286 53 70

 

Björn Westberg, CFO

+46 (0) 46 286 53 60

ir@bonesupport.com

 

Citigate Dewe Rogerson

Pip Batty, David Dible, Shabnam Bashir, Isabelle Andrews

+44 (0)20 7282 1022

bonesupport@citigatedewerogerson.com

 

 

The information was submitted for publication, through the agency of the contact person set out above, at 13.00 CET on 23rd July 2018.

Downloads

Press release PDF (182.99 KB)

BONESUPPORT appoints Michael Diefenbeck as Head of Research & Development, Medical and Clinical Affairs

18th July 2018

BONESUPPORT appoints Michael Diefenbeck as Head of Research & Development, Medical and Clinical Affairs

Lund, Sweden, 18:30 CET, 18 July 2018 – BONESUPPORT, an emerging leader in orthobiologics for the management of bone voids, announces that Michael Diefenbeck MD PhD, BONESUPPORT’s Chief Medical Officer, has been appointed to assume a broader role as Head of R&D, Medical and Clinical Affairs.

Emil Billbäck, CEO of BONESUPPORT, commented: “We are pleased to announce the expansion of Michael’s role to head of R&D, Medical and Clinical Affairs, where his experience at BONESUPPORT, both as Chief Medical Office and prior to this as an independent clinical advisor, as well as his clinical experience as an orthopedic surgeon specializing in trauma care and bone infections, will continue to be extremely valuable.

We remain focused on progressing FORTIFY to allow for a planned CERAMENT® G PMA submission in the US in 2020, generating clinical data in our key target indications, as well as broadening our product offering through new CERAMENT® formulations. Longer term we are looking to add innovative products with potential to be market disruptive, selected from our innovative pipeline.”

Jerry Chang, Executive Vice President of R&D, is leaving the Company and will transfer to a role as independent consultant, where he will be supporting BONESUPPORT in certain projects.

Both changes are effective immediately.

 

About BONESUPPORT

BONESUPPORT is an innovative and rapidly growing commercial stage orthobiologics company, based in Lund, Sweden. The Company develops and commercializes innovative injectable bio-ceramic bone graft substitutes that remodel to the patient’s own bone and have the capability of eluting drugs directly into the bone void.

BONESUPPORT’s bio-ceramic bone graft substitutes CERAMENT® BONE VOID FILLER (BVF), CERAMENT® G* and CERAMENT® V* are all based on the Company’s novel and proprietary technology platform.

The Company’s products are targeting a large addressable market opportunity across trauma, chronic osteomyelitis (bone infection), revision arthroplasty (replacement of a joint prosthesis) and infected diabetic foot.

BONESUPPORT’s total sales increased from SEK 62 million in 2015 to SEK 129 million in 2017, representing a compound annual growth rate of 45%.

The Company’s research and development is focused on the continuing development and refinement of its CERAMENT technology to extend its use into additional indications by the elution of drugs and therapeutic agents. The Company currently has a pipeline of pre-clinical product candidates that have been designed to promote bone growth.

In addition, BONESUPPORT is looking at opportunities to expand its product offering in the US and has entered into a strategic agreement with Collagen Matrix Inc. to market and distribute products that are complementary to CERAMENT BVF.

BONESUPPORT is listed on Nasdaq Stockholm and trades under the ticker “BONEX” (ISIN code: SE0009858152). Further information is available at www.bonesupport.com

*CERAMENT G: Not available in the United States, for investigational use only. 
  CERAMENT V: Not available in the United States.

BONESUPPORT and CERAMENT® are registered trademarks.

 

For more information contact:

BONESUPPORT AB

Emil Billbäck, CEO

+46 (0) 46 286 53 70

Björn Westberg, CFO

+46 (0) 46 286 53 60

ir@bonesupport.com

 

Citigate Dewe Rogerson

Pip Batty, David Dible, Shabnam Bashir, Isabelle Andrews

+44 (0)20 7282 1022

bonesupport@citigatedewerogerson.com

This information is such information as BONESUPPORT HOLDING AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 18.30 CET on 18 July 2018.

Downloads

Press release PDF (239.98 KB)

Håkan Johansson to start as BONESUPPORT’s CFO at the end of 2018

4th July 2018

Håkan Johansson to start as BONESUPPORT’s CFO at the end of 2018

Lund, Sweden, 18:00 CET, July 4 2018 – BONESUPPORT an emerging leader in Orthobiologics for the management of bone voids, announces changes in its leadership team that are expected to take place at the end of 2018, when Håkan Johansson will replace Björn Westberg as the company’s CFO. Håkan Johansson is an experienced financial executive having most recently served as CFO Tunstall Northern Europe, the UK based healthcare solutions company, and prior to that as CFO at the Swedish toy-maker BRIO.

 “Håkan Johansson has very solid CFO experience and will be a valuable addition to Bonesupport’s leadership team given the exciting journey we have ahead of us. I would like to thank Björn for his support and advice whilst I have served as CEO and his work as a lead contributor to Bonesupport’s successful IPO in June 2017. I wish Björn continued success in his future endeavors”, says Emil Billbäck, BONESUPPORT CEO.

 

About BONESUPPORT

BONESUPPORT is an innovative and rapidly growing commercial stage orthobiologics company, based in Lund, Sweden. The Company develops and commercializes innovative injectable bio-ceramic bone graft substitutes that remodel to the patient’s own bone and have the capability of eluting drugs directly into the bone void.

BONESUPPORT’s bio-ceramic bone graft substitutes CERAMENT® BONE VOID FILLER (BVF), CERAMENT® G* and CERAMENT® V* are all based on the Company’s novel and proprietary technology platform.

The Company’s products are targeting a large addressable market opportunity across trauma, chronic osteomyelitis (bone infection), revision arthroplasty (replacement of a joint prosthesis) and infected diabetic foot.

BONESUPPORT’s total sales increased from SEK 62 million in 2015 to SEK 129 million in 2017, representing a compound annual growth rate of 45%.

The Company’s research and development is focused on the continuing development and refinement of its CERAMENT technology to extend its use into additional indications by the elution of drugs and therapeutic agents. The Company currently has a pipeline of pre-clinical product candidates that have been designed to promote bone growth.

In addition, BONESUPPORT is looking at opportunities to expand its product offering in the US and has entered into a strategic agreement with Collagen Matrix Inc. to market and distribute products that are complementary to CERAMENT BVF.

BONESUPPORT is listed on Nasdaq Stockholm and trades under the ticker “BONEX” (ISIN code: SE0009858152). Further information is available at www.bonesupport.com

 

*CERAMENT G: Not available in the United States, for investigational use only.
  CERAMENT V: Not available in the United States.
BONESUPPORT and CERAMENT® are registered trademarks.

For more information contact:

BONESUPPORT AB

 

Emil Billbäck, CEO

+46 (0) 46 286 53 70

 

Citigate Dewe Rogerson

Pip Batty, David Dible, Shabnam Bashir, Isabelle Andrews

+44 (0)20 7282 1022

bonesupport@citigatedewerogerson.com

 

This information is such information as BONESUPPORT HOLDING AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 18.00 CET on 4 July 2018.

 

 

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Change in number of shares and votes in BONESUPPORT HOLDING AB (publ)

29th June 2018

Change in number of shares and votes in BONESUPPORT HOLDING AB (publ)

Lund, Sweden, 18:00 CET 29 June 2018 - During June, the number of shares and votes in BONESUPPORT HOLDING AB (publ) has increased due to the exercise of warrants. As of
29 June 2018, the number of shares and votes in BONESUPPORT HOLDING AB (publ) amounts to 50,812,116.

 

About BONESUPPORT™

BONESUPPORT is an innovative and rapidly growing commercial stage orthobiologics company, based in Lund, Sweden. The Company develops and commercializes innovative injectable bio-ceramic bone graft substitutes that remodel to the patient’s own bone and have the capability of eluting drugs directly into the bone void.

BONESUPPORT’s bio-ceramic bone graft substitutes CERAMENT® BONE VOID FILLER (BVF), CERAMENT® G* and CERAMENT® V* are all based on the Company’s novel and proprietary technology platform.

The Company’s products are targeting a large addressable market opportunity across trauma, chronic osteomyelitis (bone infection), revision arthroplasty (replacement of a joint prosthesis) and infected diabetic foot.

BONESUPPORT’s total sales increased from SEK 62 million in 2015 to SEK 129 million in 2017, representing a compound annual growth rate of 45%.

The Company’s research and development is focused on the continuing development and refinement of its CERAMENT technology to extend its use into additional indications by the elution of drugs and therapeutic agents. The Company currently has a pipeline of pre-clinical product candidates that have been designed to promote bone growth.

In addition, BONESUPPORT is looking at opportunities to expand its product offering in the US and has entered into a strategic agreement with Collagen Matrix Inc. to market and distribute products that are complementary to CERAMENT BVF.

BONESUPPORT is listed on Nasdaq Stockholm and trades under the ticker “BONEX” (ISIN code: SE0009858152). Further information is available at www.bonesupport.com

*CERAMENT G: Not available in the United States, for investigational use only. 
  CERAMENT V: Not available in the United States.

BONESUPPORT™ and CERAMENT® are registered trademarks.

For more information contact:

BONESUPPORT AB

Emil Billbäck, CEO

+46 (0) 46 286 53 70

 

Björn Westberg, CFO

+46 (0) 46 286 53 60

ir@bonesupport.com

 

Citigate Dewe Rogerson

Pip Batty, David Dible, Shabnam Bashir, Isabelle Andrews

+44 (0)20 7282 1022

bonesupport@citigatedewerogerson.com

 

This information is such information as BONESUPPORT HOLDING AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 08.30am CET on 21 June 2018.

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BONESUPPORT provides update on US orders of CERAMENT BVF

21st June 2018

BONESUPPORT provides update on US orders of CERAMENT BVF

Lund, Sweden, 08:30 CET, 21 June 2018 –  BONESUPPORT™ an emerging leader in Orthobiologics for the management of bone voids, today provides an update on the US orders of CERAMENT BVF.

Following BONESUPPORT’s decision to set up its own distribution network in the US and terminate its current exclusive distribution agreement, as announced 17 May 2018, its current distributor, Zimmer Biomet, has cancelled the majority of its orders for a 3-month period starting in June.

In-market sales of CERAMENT BVF in the US are continuing to show good growth with this increasing demand being met from Zimmer Biomet’s current inventory and the inventory of its distributor network.

“Today’s announcement highlights the importance of BONESUPPORT taking control of its commercial platform in the US. The evaluation of potential distribution partners is progressing to plan. We expect to have a strong coverage of the US market in place in late October, positioning us to create more direct and stronger relationships with our US customer base. This enhanced commercial platform will allow us to successfully market our highly differentiated products, particularly CERAMENT G, which we aim to launch in the US market in 2021”, said Emil Billbäck, CEO of BONESUPPORT.

Zimmer Biomet retains the right to sell and distribute CERAMENT BVF on an exclusive basis until 20 October 2018, and on a non-exclusive basis until 20 April 2019.

 

About BONESUPPORT™

BONESUPPORT is an innovative and rapidly growing commercial stage orthobiologics company, based in Lund, Sweden. The Company develops and commercializes innovative injectable bio-ceramic bone graft substitutes that remodel to the patient’s own bone and have the capability of eluting drugs directly into the bone void.

BONESUPPORT’s bio-ceramic bone graft substitutes CERAMENT® BONE VOID FILLER (BVF), CERAMENT® G* and CERAMENT® V* are all based on the Company’s novel and proprietary technology platform.

The Company’s products are targeting a large addressable market opportunity across trauma, chronic osteomyelitis (bone infection), revision arthroplasty (replacement of a joint prosthesis) and infected diabetic foot.

BONESUPPORT’s total sales increased from SEK 62 million in 2015 to SEK 129 million in 2017, representing a compound annual growth rate of 45%.

The Company’s research and development is focused on the continuing development and refinement of its CERAMENT technology to extend its use into additional indications by the elution of drugs and therapeutic agents. The Company currently has a pipeline of pre-clinical product candidates that have been designed to promote bone growth.

In addition, BONESUPPORT is looking at opportunities to expand its product offering in the US and has entered into a strategic agreement with Collagen Matrix Inc. to market and distribute products that are complementary to CERAMENT BVF.

BONESUPPORT is listed on Nasdaq Stockholm and trades under the ticker “BONEX” (ISIN code: SE0009858152). Further information is available at bonesupport.com

*CERAMENT G: Not available in the United States, for investigational use only.
  CERAMENT V: Not available in the United States.

BONESUPPORT™ and CERAMENT® are registered trademarks.

For more information contact:

BONESUPPORT AB

Emil Billbäck, CEO

+46 (0) 46 286 53 70

 

Björn Westberg, CFO

+46 (0) 46 286 53 60

ir@bonesupport.com

 

Citigate Dewe Rogerson

Pip Batty, David Dible, Shabnam Bashir, Isabelle Andrews

+44 (0)20 7282 1022

bonesupport@citigatedewerogerson.com

 

This information is such information as BONESUPPORT HOLDING AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 08.30am CET on 21 June 2018.

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BONESUPPORT to significantly expand its European sales organization

29th May 2018

BONESUPPORT to significantly expand its European sales organization

Lund, Sweden, 08:00 CET, 29 May 2018 –  BONESUPPORT™ an emerging leader in Orthobiologics for the management of bone voids, announces plans to expand its sales organization in Europe by employing a further 13 sales representatives in its key markets in 2018. The objective is to significantly increase the market penetration of its antibiotic-eluting products CERAMENT® G and CERAMENT® V.

"CERAMENT G and V have strong sales momentum in Europe due to their increased use in a wide range of orthopedic indications. The adoption level is particularly high in osteomyelitis, a challenging indication that generally requires repeated surgical interventions. We see significant commercial potential for CERAMENT G and V in multiple important treatment areas, including the much larger trauma indication. Today’s decision to almost double the number of sales specialists in Europe, reflects the sizeable opportunity we see for our CERAMENT products across the region in indications where we have so far had a relatively low level of penetration,” says Emil Billbäck, CEO of BONESUPPORT.

BONESUPPORT has more than 130 publications demonstrating the advantages of the CERAMENT platform in relation to the treatment of bone voids. In March 2018, three studies were presented at the British Limb Reconstruction Society (BLRS) meeting. The larger of these studies1, compared the treatment of CERAMENT G with Wright Medical’s OSTEOSET® T. The study showed clear benefits in terms of significantly better bone healing and reduced risk of recurring infections with the use of CERAMENT G, which in turn reduces patient in hospital stay.

1. Ferguson et al. (2018): The choice of local antibiotic carrier significantly affects outcome in treatment of chronic bone infection

 

About BONESUPPORT™

BONESUPPORT is an innovative and rapidly growing commercial stage orthobiologics company, based in Lund, Sweden. The Company develops and commercializes innovative injectable bio-ceramic bone graft substitutes that remodel to the patient’s own bone and have the capability of eluting drugs directly into the bone void.

BONESUPPORT’s bio-ceramic bone graft substitutes CERAMENT® BONE VOID FILLER (BVF), CERAMENT® G* and CERAMENT® V* are all based on the Company’s novel and proprietary technology platform.

The Company’s products are targeting a large addressable market opportunity across trauma, chronic osteomyelitis (bone infection), revision arthroplasty (replacement of a joint prosthesis) and infected diabetic foot.

BONESUPPORT’s total sales increased from SEK 62 million in 2015 to SEK 129 million in 2017, representing a compound annual growth rate of 45%.

The Company’s research and development is focused on the continuing development and refinement of its CERAMENT technology to extend its use into additional indications by the elution of drugs and therapeutic agents. The Company currently has a pipeline of pre-clinical product candidates that have been designed to promote bone growth.

In addition, BONESUPPORT is looking at opportunities to expand its product offering in the US and has recently entered into a strategic agreement with Collagen Matrix Inc. to market and distribute products that are complementary to CERAMENT BVF.

BONESUPPORT is listed on Nasdaq Stockholm and trades under the ticker “BONEX” (ISIN code: SE0009858152). Further information is available at bonesupport.com

*CERAMENT G: Not available in the United States, for investigational use only.
  CERAMENT V: Not available in the United States.

BONESUPPORT™ and CERAMENT® are registered trademarks.

For more information contact:

BONESUPPORT AB

Emil Billbäck, CEO

+46 (0) 46 286 53 70

Björn Westberg, CFO

+46 (0) 46 286 53 60

ir@bonesupport.com

 

Citigate Dewe Rogerson

Pip Batty, David Dible, Shabnam Bashir, Isabelle Andrews

+44 (0)20 7282 1022

bonesupport@citigatedewerogerson.com

This information is such information as BONESUPPORT HOLDING AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 08.00am CET on 29 May 2018.

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BONESUPPORT Signs Strategic Agreement with Collagen Matrix, Inc. to Expand Product Offering in the US

24th May 2018

BONESUPPORT Signs Strategic Agreement with Collagen Matrix, Inc. to Expand Product Offering in the US

Lund, Sweden, 13.00 CET, 24 May 2018 – BONESUPPORT, announces an agreement with Collagen Matrix, Inc. that will allow it to expand its US offering with products that are complementary to CERAMENT BVF. BONESUPPORT will start selling and marketing selected Collagen Matrix bone graft substitute products under its own brand name, and through its own US distribution network in Q4 2018.

Emil Billbäck, CEO of BONESUPPORT said, “Today’s deal with Collagen Matrix is important to our plans to build a larger, faster growing US business under our own control. The Collagen Matrix products can be osteoinductive and osteogenic when combined with bone marrow aspirate making them complementary to CERAMENT BVF, which is osteoconductive.  We intend to launch these products under our own brand name later this year giving us a suite of products that will allow us to meet more of the bone graft substitute needs of the orthopedic surgeon. Establishing a broader portfolio of bone graft substitute technologies will also significantly improve our competitive position with payors including GPO/IDN’s (Group Purchasing Organization/Integrated Delivery Network), and help our new distribution channel to be more competitive.”

Collagen Matrix products, when combined with autogenous bone marrow, are both osteoinductive and osteogenic. They are used to fill bony voids or gaps of the skeletal system caused by surgery or traumatic injury.

On 17 May 2018, BONESUPPORT announced that it intended to create its own optimal US commercial platform by:

  • Building its own network of independent distributors that will be key in driving the   sales of BONESUPPORT’s products, to a broad range of orthopedic indications.
  • Growing the size and capabilities of its own US commercial organization, which will increase from 14 to around 23 employees by the end of 2018
  • Extending its product offering based on new formulations of CERAMENT as well as synergistic bone graft substitute products via strategic collaborations such as the one announced with Collagen Matrix today.

About Collagen Matrix Inc.

Collagen Matrix, Inc., founded in 1997, delivers a full line of the highest-quality collagen and mineral based medical devices that support the body’s natural ability to regenerate. The Company currently manufactures finished medical devices in the areas of Dental, Spine, Orthopaedic, Dural Repair and Nerve Repair Surgery. The evolution of the Company’s leadership, proprietary technologies, manufacturing expertise and product portfolio has established a solid foundation for continued growth.  

More information about Collagen Matrix can be found at www.CollagenMatrix.com

 

About BONESUPPORT™

BONESUPPORT is an innovative and rapidly growing commercial stage orthobiologics company, based in Lund, Sweden. The Company develops and commercializes innovative injectable bio-ceramic bone graft substitutes that remodel to the patient’s own bone and have the capability of eluting drugs directly into the bone void.

BONESUPPORT’s marketed bio-ceramic bone graft substitutes CERAMENT® BONE VOID FILLER (BVF), CERAMENT® G* and CERAMENT® V* are all based on the Company’s novel and proprietary CERAMENT technology platform.

The Company’s products are targeting a large addressable market opportunity across trauma, chronic osteomyelitis (bone infection), revision arthroplasty (replacement of a joint prosthesis) and infected diabetic foot.

BONESUPPORT’s total sales increased from SEK 62 million in 2015 to SEK 129 million in 2017, representing a compound annual growth rate of 45%.

The Company’s research and development is focused on the continuing development and refinement of its CERAMENT technology to extend its use into additional indications by the elution of other drugs and therapeutic agents. The Company currently has a pipeline of pre-clinical product candidates that have been designed to promote bone growth.

BONESUPPORT is listed on Nasdaq Stockholm and trades under the ticker “BONEX” (ISIN code: SE0009858152). Further information is available at bonesupport.com

*CERAMENT G: Not available in the United States, for investigational use only. CERAMENT V: Not available in the United States

BONESUPPORT™ and CERAMENT® are registered trademarks. 

For more information contact:

Emil Billbäck, CEO

+46 (0) 46 286 53 70

 

Björn Westberg, CFO

+46 (0) 46 286 53 60

ir@bonesupport.com

 

Citigate Dewe Rogerson

Pip Batty, David Dible, Shabnam Bashir, Isabelle Andrews

+44 (0)20 7282 1022

bonesupport@citigatedewerogerson.com

This information is such information as BONESUPPORT HOLDING AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 13.00 CET on 24 May 2018.

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BULLETIN FROM THE ANNUAL SHAREHOLDERS’ MEETING IN BONESUPPORT HOLDING AB ON 22 MAY 2018

22nd May 2018

BULLETIN FROM THE ANNUAL SHAREHOLDERS’ MEETING IN BONESUPPORT HOLDING AB ON 22 MAY 2018

Lund, Sweden, 13:00 CET 22 May 2018 - Today, on 22 May 2018, an annual shareholders’ meeting was held in BONESUPPORT HOLDING AB. A summary of the resolutions adopted follows below. All resolutions were adopted with the required majority.

Resolution on adoption of accounts and allocation of the company’s result

The annual shareholders’ meeting resolved to adopt the profit and loss statement and balance sheet and the group profit and loss statement and the group balance sheet. The annual shareholders’ meeting also resolved to allocate the company’s result in accordance with the proposal from the board meaning that no dividends are paid and that available total funds of SEK 889,317,383 are carried forward to a new account.

Discharge from liability of the members of the board and the CEO

The annual shareholders’ meeting resolved to discharge the members of the board and the CEO from liability for the financial year 2017.

Election of board members and auditor as well as remuneration for the board members and auditor

The annual shareholders’ meeting resolved, in accordance with the proposal from the Nomination Committee, to re-elect Håkan Björklund, Björn Odlander, Nina Rawal, Lars Lidgren, Tone Kvåle and Lennart Johansson as ordinary board members and to elect Simon Cartmell as new ordinary board member. Håkan Björklundwas re-elected as chairman of the board.

Furthermore, the annual shareholders’ meeting resolved that board remuneration shall be paid with a total of SEK 1,565,000, of which SEK 325,000 shall be paid to the chairman of the board and of which SEK 150,000 shall be paid to each of the other board members who are not employed by the company. Remuneration for committee work shall be paid with SEK 125,000 to the chairman of the Audit Committee, with SEK 70,000 to each of the other members of the Audit Committee, with SEK 50,000 to the chairman of the Remuneration Committee and with SEK 25,000 to each of the other members of the Remuneration Committee.

The annual shareholders’ meeting also resolved to re-elect Ernst & Young AB as the accounting firm and remuneration for the auditor shall be paid in accordance with invoiced amounts in accordance with customary charging standards. Ernst & Young AB has informed that Johan Thuresson will continue to be appointed as the responsible auditor.

Resolution on instruction and charter for the Nomination Committee

The annual shareholders’ meeting resolved that a Nomination Committee shall be appointed before the coming election and remuneration. The Nomination Committee shall consist of four members, representing the three largest shareholders as per the end of September, together with the chairman of the board of directors. Furthermore, an instruction and charter for the Nomination Committee was adopted.

Determination of Remuneration Policy for senior executives

The annual shareholders’ meeting resolved in accordance with the proposal from the board to adopt a Remuneration Policy regarding determination of remuneration and other benefits for the CEO and other senior executives.

Resolution on implementation of a long-term incentive program for senior executives by way of (A) directed issue of warrants; and (B) approval of transfer of warrants

The annual shareholders' meeting resolved, in accordance with the proposal from the board, to implement a long-term incentive program for senior executives by way of directed issue of warrants and approval of transfer of warrants (the “Warrants Program 2018/2021”).

The Warrants Program 2018/2021 shall comprise a maximum of 1,175,000 warrants. With deviation from the shareholders’ preferential rights, the right to subscribe for the warrants shall only vest in a wholly owned subsidiary within the group. Each warrant shall entitle to subscription of one new ordinary share in the company for a subscription price per share corresponding to 125 per cent of the volume weighted average price according to Nasdaq Stockholm’s official price list for shares in the company during the period as from 14 May 2018 to and including 18 May 2018. Subscription of shares by virtue of the warrants may be effected as from 1 June 2021 up to and including 30 June 2021. Transfer of warrants to participants in the Warrants Program 2018/2021 shall be made at fair market value at the time of the transfer which shall be established by Öhrlings Pricewaterhouse Coopers AB, as an independent valuation institute, in accordance with the Black Scholes formula.     

The reasons for the implementation of the Warrants Program 2018/2021 and the deviation from the shareholders’ preferential rights for subscription of the new warrants are to be able to create possibilities for the company to retain senior executives by offering a long term ownership engagement. Such ownership engagement is expected to contribute to an increased alignment of interests between the participating senior executives and the shareholders, and also promote a long-term commitment to the company’s development. In case all warrants issued in connection with the Warrants Program 2018/2021 are exercised for subscription of new shares, a total of 1,175,000 new shares will be issued, which corresponds to a dilution of approximately 2.26 per cent of the company’s share capital and votes after full dilution, calculated on the number of shares that will be added upon full utilization of all warrants issued under the Warrants Program 2018/2021. 

Resolution on amendment of the Articles of Association

The annual shareholders' meeting resolved, in accordance with the proposal from the board, to amend the company’s Articles of Association by incorporation of a new share class. The new section means that shares may be issued in two classes, ordinary shares and series C shares. The purpose of the incorporation of the new share class is to enable issuance of series C shares under the share saving programs for employees and certain members of the board of directors which was resolved upon by the annual shareholders’ meeting. Following the incorporation of the new section in the Articles of Association, the already existing shares shall be ordinary shares.

Resolution on implementation of a long-term incentive program for employees by way of (A) implementation of a performance-based share saving program; (B) authorization on directed issues of series C shares; (C) authorization on repurchase of series C shares; and (D) resolution on transfer of own ordinary shares

The annual shareholders' meeting resolved, in accordance with the proposal from the board, to implement a long-term incentive program for employees(“LTI 2018”). LTI 2018 means that up to approximately 25 employees will be offered the possibility to participate in a performance-based share saving program, which under certain circumstances will entitle the participant allotment of ordinary shares in the company free of charge for each invested ordinary share in the company (the “Saving Shares”). Investment in Saving Shares shall be made on 31 December 2018 at the latest (the “Investment Period”). If the Saving Shares are retained as from the expiration of the Investment Period to and including 31 December 2021 (the “Saving Period”) and the participant has continued to be employed by the company throughout the Saving Period, the participant is entitled to allotment of additional ordinary shares in the company free of charge (the “Performance Shares”), provided that certain performance targets are achieved or exceeded. The total maximum number of Performance Shares that may be issued within LTI 2018 amounts to 500,000, which corresponds to a dilution of approximately 0.97 per cent of the company’s share capital and votes after full dilution, calculated on the number of shares that will be added upon full issuance of Performance Shares in connection with LTI 2018.    

In order to secure the company's delivery of Performance Shares to the participants in LTI 2018, the annual shareholders' meeting also resolved to authorize the board of directors to resolve on directed issues of series C shares, whereby the new shares, with deviation from the shareholders' preferential rights, only may be subscribed for by a bank or a securities company at a subscription price which corresponds to the quota value of the shares. Furthermore, the annual shareholders’ meeting resolved to authorize the board of directors to resolve to repurchase its own series C shares and the annual shareholders’ meeting also resolved on transfer of own ordinary shares.

Resolution on implementation of a long-term incentive program for certain members of the board of directors by way of (A) implementation of a performance-based share saving program; (B) authorization on directed issues of series C shares; (C) authorization on repurchase of series C shares; and (D) resolution on transfer of own ordinary shares

The annual shareholders' meeting resolved, in accordance with the proposal from the Nomination Committee, to implement a long-term incentive program for certain members of the board of directors(“Board LTI 2018”). Board LTI 2018 means that the members of the board of directors, Simon Cartmell, Tone Kvåle and Lennart Johansson will be offered the possibility to participate in a performance-based share saving program, which under certain circumstances will entitle the participant allotment of ordinary shares in the company free of charge for each invested ordinary share in the company (the “Saving Shares”). Investment in Saving Shares shall be made on 31 December 2018 at the latest (the “Investment Period”). If the Saving Shares are retained as from the expiration of the Investment Period to and including 31 December 2021 and the participant has continued to be a member of the board of directors of the company until the date of when the annual shareholders’ meeting 2021 is held (i.e. most likely in May 2021), the participant is entitled to allotment of additional ordinary shares in the company free of charge (the “Performance Shares”), provided that a performance target is achieved or exceeded. The total maximum number of Performance Shares that may be issued within Board LTI 2018 amounts to 120,000, which corresponds to a dilution of approximately 0.24 per cent of the company’s share capital and votes after full dilution, calculated on the number of shares that will be added upon full issuance of Performance Shares in connection with Board LTI 2018.    

In order to secure the company's delivery of Performance Shares to the participants in Board LTI 2018, the annual shareholders' meeting also resolved to authorize the board of directors to resolve on directed issues of series C shares, whereby the new shares, with deviation from the shareholders' preferential rights, only may be subscribed for by a bank or a securities company at a subscription price which corresponds to the quota value of the shares. Furthermore, the annual shareholders’ meeting resolved to authorize the board of directors to resolve to repurchase its own series C shares and the annual shareholders’ meeting also resolved on transfer of own ordinary shares.

Lund on 22 May 2018

BONESUPPORT HOLDING AB (PUBL)

 

About BONESUPPORTTM

BONESUPPORT is an innovative and rapidly growing commercial stage orthobiologics company, based in Lund, Sweden. The Company develops and commercializes innovative injectable bio-ceramic bone graft substitutes that remodel to the patient’s own bone and have the capability of eluting drugs directly into the bone void.

BONESUPPORT’s marketed bio-ceramic bone graft substitutes CERAMENT® BONE VOID FILLER (BVF), CERAMENT® G* and CERAMENT® V* are all based on the Company’s novel and proprietary CERAMENT technology platform.

The Company’s products are targeting a large addressable market opportunity across trauma, chronic osteomyelitis (bone infection), revision arthroplasty (replacement of a joint prosthesis) and infected diabetic foot. BONESUPPORT’s total sales increased from SEK 62 million in 2015 to SEK 129 million in 2017, representing a compound annual growth rate of 45 percent. The Company’s financial target is to achieve revenue exceeding SEK 500 million in the financial year 2020, with a gross margin exceeding 85 percent and a positive operating profit.

The Company’s research and development is focused on the continuing development and refinement of its CERAMENT technology to extend its use into additional indications by the elution of other drugs and therapeutic agents. The Company currently has a pipeline of pre-clinical product candidates that have been designed to promote bone growth.

BONESUPPORT is listed on Nasdaq Stockholm and trades under the ticker “BONEX” (ISIN code: SE0009858152). Further information is available at bonesupport.com

*CERAMENT G: Not available in the United States, for investigational use only. CERAMENT V: Not available in the United States

BONESUPPORT™ and CERAMENT® are registered trademarks.

For more information contact:

Emil Billbäck, CEO                                                                          

Tel: +46 (0) 46 286 53 70

 

Björn Westberg, CFO

Tel: +46 (0) 46 286 53 60

Email: ir@bonesupport.com

The information was submitted for publication, through the agency of the contact persons set out above, at 13:00 CET on 22 May 2018.

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BONESUPPORT creates its own US Commercial Platform

17th May 2018

BONESUPPORT creates its own US Commercial Platform

Lund, Sweden, 08.45 CET, 17 May 2018 – BONESUPPORT HOLDING AB (publ) announces today that the current distribution agreement has been terminated and will be replaced by a network of independent distributors and its own commercial organization. This will allow BONESUPPORT to increase its market penetration while creating a stronger platform for current products and future launches in the US market.

“Taking control of our commercial platform in the US is crucial to the execution of our strategy to become a leading global orthobiologics company. We will be able to create a more direct relation with the US customers while better capitalizing the potential of our highly differentiated products, particularly CERAMENT G, which we hope will take to the market in 2021”, says Emil Billbäck, CEO of BONESUPPORT.

The company intends to create the optimal US commercial platform by:

  • Building its own network of independent distributors driving the sales of the BONESUPPORT’s products, to a broad range of orthopedic indications.
  • Extend the product offering based on new formulations of CERAMENT as well as synergistic bone graft substitute products.  
  • Increase the own commercial organization from 12 to 23 persons. 

BONESUPPORT will start selling direct on October 20th 2018.

“CERAMENT G will be a highly innovative product – the first of its kind in the US market – the recruitment of the FORTIFY IDE study, which will provide data for the PMA application of CERAMENT G in 2020, is running according to plan. Expanding our commercial footprint, establishing direct access with our customers, and bolstering our product offering in the US will allow us to build a strong and increasing foundation in the world’s largest market for bone graft substitutes.”, comments Patrick O’Donnell, Executive Vice President of Commercial Operations, North America.

The Company expects that this decided change in market commercialization eventually will generate higher sales volumes in the US. In the short term, the turnover will be less in the US. This could also lead to that the 2020 targets will be achieved later than previously communicated. We will present updated objectives during Q3 2018 after the initiated strategic review is completed.


Conference Call/Webcast Details

The Company will host a conference call and an online presentation at 09:30 am CET on Thursday 17 May.

The dial-in numbers for the conference call are:

UK: +44 20 3008 9808

SE:  +46 85 063 95 49

US: +1 85 5831 5946

Webcast

The presentation will also be webcast and can be accessed from the following web address:

https://tv.streamfabriken.com/2018-05-17-bonesupport-pressconference

Hosts: Emil Billbäck, CEO and Björn Westberg, CFO

 

About BONESUPPORT™

BONESUPPORT is an innovative and rapidly growing commercial stage orthobiologics company, based in Lund, Sweden. The Company develops and commercializes innovative injectable bio-ceramic bone graft substitutes that remodel to the patient’s own bone and have the capability of eluting drugs directly into the bone void.

BONESUPPORT’s marketed bio-ceramic bone graft substitutes CERAMENT® BONE VOID FILLER (BVF), CERAMENT® G* and CERAMENT® V* are all based on the Company’s novel and proprietary CERAMENT technology platform. The Company’s products are targeting a large addressable market opportunity across trauma, chronic osteomyelitis (bone infection), revision arthroplasty (replacement of a joint prosthesis) and infected diabetic foot.

BONESUPPORT’s total sales increased from SEK 62 million in 2015 to SEK 129 million in 2017, representing a compound annual growth rate of 45%.

The Company’s research and development is focused on the continuing development and refinement of its CERAMENT technology to extend its use into additional indications by the elution of other drugs and therapeutic agents. The Company currently has a pipeline of pre-clinical product candidates that have been designed to promote bone growth.

BONESUPPORT is listed on Nasdaq Stockholm and trades under the ticker “BONEX” (ISIN code: SE0009858152). Further information is available at bonesupport.com.

*CERAMENT G: Not available in the United States, for investigational use only.
  CERAMENT V: Not available in the United States

BONESUPPORT™ and CERAMENT® are registered trademarks.

For more information contact:

BONESUPPORT AB

Emil Billbäck, CEO

+46 (0) 46 286 53 70

Björn Westberg, CFO

+46 (0) 46 286 53 60

ir@bonesupport.com

 

Citigate Dewe Rogerson

Pip Batty, David Dible, Shabnam Bashir, Isabelle Andrews

+44 (0)20 7282 1022

bonesupport@citigatedewerogerson.com

 

This information is such information as BONESUPPORT HOLDING AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 07.45 CET on 17 May 2018.

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BONESUPPORT HOLDING AB (Publ) – Q1 Interim Report

4th May 2018

BONESUPPORT HOLDING AB (Publ) – Q1 Interim Report

January – March 2018

Lund, Sweden, 08.00 CET, 4 May 2018 – BONESUPPORTTM, an emerging leader in innovative injectable bio-ceramic bone substitute products to treat bone voids caused by trauma, infection, disease or related surgery based on its unique CERAMENT® platform today announces the publication of its Q1 Interim Report - January – March 2018.

 

BEST QUARTER EVER IN EUROPE

FINANCIAL HIGHLIGHTS

JANUARY – MARCH 2018

  • Net Sales amounted to SEK 31.1million (32.5), a decrease of 4%. Sales were flat in constant currency terms and were 15.2% higher than Q4 2017
  • Gross margin of 82.1% (88.8)
  • Operating loss of SEK ‐33.1 million (‐27.4)
  • Earnings per share, before and after dilution was SEK ‐0.67 (‐1.07)

 

BUSINESS HIGHLIGHTS

JANUARY – MARCH 2018

  • Emil Billbäck started as new CEO on 1 March, replacing Richard Davies
  • Positive CERAMENT® G clinical data for the treatment of bone infections were presented at the British Limb Reconstruction Society (BLRS) Meeting 2018, in March
  • First sales to 3 of the top 20 trauma centers in Italy, via Citieffe, our new distributor
  • BONESUPPORT repaid an outstanding loan from Kreos Capital amounting to SEK 93.3 million (EUR 9.5 million)

 

Emil Billbäck, CEO of BONESUPPORT, said: “The first quarter in 2018 was in line with our expectations and the strong market penetration in Europe continued and delivered its best quarter ever. The sales in the US improved significantly from the last quarter in 2017 despite negative impact from Zimmer Biomet’s logistic problems.”

 

The full Report is available by clicking on the links below:

Outside the US: https://bonesupport.com/en-eu/financial-reports-inv/

US: https://bonesupport.com/en-us/financial-reports-us/

The report will be available on BONESUPPORT’s website from 08:00 am CET the same day and the presentation from the webcast will be uploaded during the day on 4 May.

 

Conference Call/Webcast Details

The Company will host a conference call and an online presentation at 10.00am CET today.

The dial-in numbers for the conference call are:

UK: +44 2030089810

SE: +46 856642669

US: +1 8557532236

 

Webcast

The presentation will also be webcast and can be accessed from the following web address:

https://financialhearings.com/event/10857

Hosts: Emil Billbäck, CEO, and Björn Westberg, CFO

 

 

About BONESUPPORT

BONESUPPORT is an innovative and rapidly growing commercial stage orthobiologics company, based in Lund, Sweden. The Company develops and commercializes innovative injectable bio-ceramic bone graft substitutes that remodel to the patient’s own bone and have the capability of eluting drugs directly into the bone void.

BONESUPPORT’s marketed bio-ceramic bone graft substitutes CERAMENT® BONE VOID FILLER (BVF), CERAMENT® G* and CERAMENT® V* are all based on the Company’s novel and proprietary CERAMENT technology platform.

The Company’s products are targeting a large addressable market opportunity across trauma, chronic osteomyelitis (bone infection), revision arthroplasty (replacement of a joint prosthesis) and infected diabetic foot.

BONESUPPORT’s total sales increased from SEK 62 million in 2015 to SEK 129 million in 2017, representing a compound annual growth rate of 45%.

The Company’s research and development is focused on the continuing development and refinement of its CERAMENT technology to extend its use into additional indications by the elution of other drugs and therapeutic agents. The Company currently has a pipeline of pre-clinical product candidates that have been designed to promote bone growth.

BONESUPPORT is listed on Nasdaq Stockholm and trades under the ticker “BONEX” (ISIN code: SE0009858152). Further information is available at bonesupport.com

*CERAMENT G: Not available in the United States, for investigational use only. CERAMENT V: Not available in the United States

BONESUPPORT and CERAMENT® are registered trademarks.

For more information contact:

Emil Billbäck, CEO

+46 (0) 46 286 53 70

Björn Westberg, CFO

+46 (0) 46 286 53 60

ir@bonesupport.com

 

Citigate Dewe Rogerson

Pip Batty, David Dible, Shabnam Bashir, Isabelle Andrews

+44 (0)20 7282 1022

bonesupport@citigatedewerogerson.com

 

This information is such information as BONESUPPORT HOLDING AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 08.00am CET on 4 February 2018.

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BONESUPPORT HOLDING AB (publ) publishes Annual Report 2017

30th April 2018

BONESUPPORT HOLDING AB (publ) publishes Annual Report 2017

Lund, Sweden, 7.30 p.m. CET, 30 April 2018 – BONESUPPORTTM, an emerging leader in innovative injectable bio-ceramic bone substitute products to treat bone voids caused by trauma, infection, disease or related surgery based on its unique CERAMENT® platform, has today published its 2017 Annual Report. The report summarises the business, as well as highlights for 2017, and provides insights into the company’s strategy.

The Annual Report is attached to this announcement and is also available via the website: bonesupport.com.

The English text in the annual report is an unofficial translation. In case of any discrepancies between the Swedish text and the English translation, the Swedish text shall prevail.

 

About BONESUPPORT™

BONESUPPORT is an innovative and rapidly growing commercial stage orthobiologics company, based in Lund, Sweden. The Company develops and commercializes innovative injectable bio-ceramic bone graft substitutes that remodel to the patient’s own bone and have the capability of eluting drugs directly into the bone void.

BONESUPPORT’s marketed bio-ceramic bone graft substitutes CERAMENT® BONE VOID FILLER (BVF), CERAMENT® G* and CERAMENT® V* are all based on the Company’s novel and proprietary CERAMENT technology platform.

The Company’s products are targeting a large addressable market opportunity across trauma, chronic osteomyelitis (bone infection), revision arthroplasty (replacement of a joint prosthesis) and infected diabetic foot.

BONESUPPORT’s total sales increased from SEK 62 million in 2015 to SEK 129 million in 2017, representing a compound annual growth rate of 45%.

The Company’s research and development is focused on the continuing development and refinement of its CERAMENT technology to extend its use into additional indications by the elution of other drugs and therapeutic agents. The Company currently has a pipeline of pre-clinical product candidates that have been designed to promote bone growth.

BONESUPPORT is listed on Nasdaq Stockholm and trades under the ticker “BONEX” (ISIN code: SE0009858152). Further information is available at bonesupport.com

*CERAMENT G: Not available in the United States, for investigational use only. CERAMENT V: Not available in the United States

BONESUPPORT™ and CERAMENT® are registered trademarks.

For more information contact:

Emil Billbäck, CEO

+46 (0) 46 286 53 70

Björn Westberg, CFO

+46 (0) 46 286 53 60

ir@bonesupport.com

 

Citigate Dewe Rogerson

Pip Batty, David Dible, Shabnam Bashir, Isabelle Andrews

+44 (0)20 7282 1022

bonesupport@citigatedewerogerson.com

 

This information is such information as BONESUPPORT HOLDING AB (publ) is obliged to make public pursuant to the Swedish Securities Markets Act. The information was submitted for publication, through the agency of the contact person set out above, at 7.30 p.m. CET on April 30, 2018.

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BONESUPPORT HOLDING AB (publ) – Q1 2018 Interim Report – invitation to conference call and webcast

27th April 2018

BONESUPPORT HOLDING AB (publ) – Q1 2018 Interim Report – invitation to conference call and webcast

Lund, Sweden, 08.00 CET, 27 April 2018 – BONESUPPORTTM, an emerging leader in innovative injectable bio-ceramic bone substitute products to treat bone voids caused by trauma, infection, disease or related surgery based on its unique CERAMENT® platform, will publish its Q1 2018 Interim Report on Friday 4 May 2018 at 8am CET.

The Company will also host a conference call and an online presentation on the same day at 10am CET.

The dial-in numbers for the conference call are:

UK: +44 2030089810

SE: +46 856642669

US: +1 8557532236

The presentation will also be webcast and can be accessed from the following web address:

https://financialhearings.com/event/10857

Hosts: Emil Billbäck, CEO, and Björn Westberg, CFO

 

About BONESUPPORT™

BONESUPPORT is an innovative and rapidly growing commercial stage orthobiologics company, based in Lund, Sweden. The Company develops and commercializes innovative injectable bio-ceramic bone graft substitutes that remodel to the patient’s own bone and have the capability of eluting drugs directly into the bone void.

BONESUPPORT’s marketed bio-ceramic bone graft substitutes CERAMENT® BONE VOID FILLER (BVF), CERAMENT® G* and CERAMENT® V* are all based on the Company’s novel and proprietary CERAMENT technology platform.

The Company’s products are targeting a large addressable market opportunity across trauma, chronic osteomyelitis (bone infection), revision arthroplasty (replacement of a joint prosthesis) and infected diabetic foot.

BONESUPPORT’s total sales increased from SEK 62 million in 2015 to SEK 129 million in 2017, representing a compound annual growth rate of 45%. The Company’s financial target is to achieve revenue exceeding SEK 500 million in the financial year 2020, with a gross margin exceeding 85 percent and a positive operating profit.

The Company’s research and development is focused on the continuing development and refinement of its CERAMENT technology to extend its use into additional indications by the elution of other drugs and therapeutic agents. The Company currently has a pipeline of pre-clinical product candidates that have been designed to promote bone growth.

BONESUPPORT is listed on Nasdaq Stockholm and trades under the ticker “BONEX” (ISIN code: SE0009858152). Further information is available at bonesupport.com

*CERAMENT G: Not available in the United States, for investigational use only. CERAMENT V: Not available in the United States

BONESUPPORT™ and CERAMENT® are registered trademarks.

For more information contact:

Emil Billbäck, CEO

+46 (0) 46 286 53 70

Björn Westberg, CFO

+46 (0) 46 286 53 60

ir@bonesupport.com

 

Citigate Dewe Rogerson

Pip Batty, David Dible, Shabnam Bashir, Isabelle Andrews

+44 (0)20 7282 1022

bonesupport@citigatedewerogerson.com

 

This information is such information as BONESUPPORT HOLDING AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 08.00am CET on 27th April 2018.

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NOTICE OF ANNUAL SHAREHOLDERS’ MEETING IN BONESUPPORT HOLDING AB

20th April 2018

NOTICE OF ANNUAL SHAREHOLDERS’ MEETING IN BONESUPPORT HOLDING AB

The English text is an unofficial translation. In case of any discrepancies between the Swedish text and the English translation, the Swedish text shall prevail.

The shareholders in BONESUPPORT HOLDING AB, Reg. No. 556802-2171, are hereby invited to attend the annual shareholders’ meeting (Sw. årsstämma) to be held at Elite Hotel Ideon, Scheelevägen 27 in Lund, Sweden on Tuesday 22 May 2018 at 10.00 a.m.

Right to participate and notice of participation

Shareholders wishing to attend the annual shareholders’ meeting must:

  • partly be registered in the company’s share register kept by Euroclear Sweden AB (the Swedish Securities Register Center) as of Wednesday 16 May 2018; and
  • partly notify the company of their intention to participate in the annual shareholders’ meeting no later than on Wednesday 16 May 2018, by mail to address BONESUPPORT HOLDING AB, att: Bolagsstämma, Scheelevägen 19, SE-223 70 Lund, by e-mail to legal@bonesupport.com or by phone to +46 (0) 286 53 70. The notice shall specify the shareholder’s complete name, personal or company registration number, registered shareholding, address, telephone number during work hours and, when applicable, information on the number of advisors (two at the most). 

 

Trustee registered shares

Shareholders who have their holdings trustee-registered must temporarily register the shares in their own name in order to be entitled to participate in the annual shareholders’ meeting. Such temporary re-registration of ownership must be implemented no later than as of Wednesday 16 May 2018, meaning that the shareholders must well in advance before this date request their trustees thereof.

Proxies etc.

A proxy representing a shareholder must bring a written, dated and by the shareholder signed power of attorney to the annual shareholders’ meeting. The power of attorney must not be older than one year, unless a longer validity term (maximum five years) have been stipulated. Should the power of attorney be issued by a legal entity, a certified copy of a registration certificate (Sw. registreringsbevis) or equivalent document shall be presented at the meeting. In order to facilitate the preparations before the annual shareholders’ meeting, a copy of the power of attorney and other proof of authority should be attached to the notice of participation. A template power of attorney can be found at the company website (bonesupport.com), and will be sent to the shareholders who request it and state their address. 

Proposed agenda

0. Opening of the meeting.

1. Election of chairman of the meeting.

2. Preparation and approval of voting list.

3. Approval of the agenda.

4. Election of one or two persons to approve the minutes.

5. The question as to whether the meeting has been duly convened.

6. Address by the CEO.

7. Presentation of the annual report and the auditor’s report and the annual report for the group and the auditor’s report for the group.

8. Resolutions in respect of

a. adoption of the profit and loss statement and balance sheet and the group profit and loss statement and the group balance sheet;

b. allocation of the company’s profit in accordance with the adopted balance sheet; and

c. the discharge from liability of the members of the board of directors and the CEO.

9. Determination of the number of members of the board and the number of auditors.

10. Determination of fees to the board of directors and the auditors.

11. Election of members of the board, chairman of the board as well as election of auditors and deputy auditors.

12. Resolution on instruction and charter for the Nomination Committee.

13. Determination of Remuneration Policy for senior executives.

14. Resolution on implementation of a long-term incentive program for senior executives by way of (A) directed issue of warrants; and (B) approval of transfer of warrants.

15. Resolution on amendment of the Articles of Association.

16. Resolution on implementation of a long-term incentive program for employees by way of (A) implementation of a performance-based share saving program; (B) authorization on a directed issue of series C shares; (C) authorization for repurchase of series C shares; and (D) resolution on transfer of own ordinary shares.

17. Resolution on implementation of a long-term incentive program for certain members of the board of directors by way of (A) implementation of a performance-based share saving program; (B) authorization on a directed issue of series C shares; (C) authorization for repurchase of series C shares; and (D) resolution on transfer of own ordinary shares.

18. Closing of the meeting.


Resolution proposals

Item 1: Election of chairman of the meeting

The Nomination Committee, consisting of Jacob Gunterberg (chairman), representing HealthCap V L.P, Johan Kördel, representing Lundbeckfonden Invest A/S, Jonas Jendi, representing Stiftelsen Industrifonden, and the chairman of the board, Håkan Björklund, proposes that attorney Ola Grahn is elected as chairman of the meeting.

Item 8 b: Resolution in respect of allocation of the company’s profit in accordance with the adopted balance sheet 

The board of directors proposes that no dividends are paid and that available total funds of SEK 889,317,383 are carried forward to a new account. 

Item 9: Determination of the number of members of the board and the number of auditors

The Nomination Committee proposes to the annual shareholders’ meeting that the number of the members of the board shall be seven. Furthermore, it is proposed that one registered accounting firm is appointed as auditor until the end of the next annual shareholders’ meeting

Item 10: Determination of fees to the board of directors and the auditors 

The Nomination Committee proposes to the annual shareholders’ meeting that board remuneration shall be paid with a total of SEK 1,565,000 (SEK 1,415,000 previous year). The proposal means that remuneration shall be paid with SEK 325,000 to the chairman of the board (unchanged since previous year) and with SEK 150,000 to each of the other board members who are not employed by the company (unchanged since previous year). It is further proposed that remuneration for committee work shall be paid with SEK 125,000 to the chairman of the audit committee (unchanged since previous year), with SEK 70,000 to each of the other members of the audit committee (unchanged since previous year), with SEK 50,000 to the chairman of the remuneration committee (unchanged since previous year) and with SEK 25,000 to each of the other members of the remuneration committee (unchanged since previous year).

Remuneration to the auditor is proposed to be paid in accordance with invoiced amounts in accordance with customary charging standards. 

Item 11: Election of members of the board, chairman of the board as well as election of auditors and deputy auditors

The Nomination Committee proposes to the annual shareholders’ meeting that Håkan Björklund, Björn Odlander, Nina Rawal, Lars Lidgren, Tone Kvåle and Lennart Johansson are re-elected as ordinary board members and that Simon Cartmell is elected as new ordinary board member. The Nomination Committee further proposes to the annual shareholders’ meeting that Håkan Björklund is re-elected as chairman of the board. 

Information on the board members proposed for re-election can be found at the company website and in the Annual Report (bonesupport.com). Information on the candidate proposed for new election can be found in the Nomination Committee’s reasoned statement. 

Furthermore, the Nomination Committee proposes to the annual shareholders’ meeting, in accordance with the recommendation from the audit committee, that Ernst Young AB is re-elected as accounting firm. Ernst & Young AB has announced that Johan Thuresson will continue to be the auditor in charge.

Item 12: Resolution on instruction and charter for the Nomination Committee 

The Nomination Committee proposes that that an instruction and charter for the Nomination Committee is adopted in accordance with the following main content. 

The Nomination Committee shall consist of four members, representing the three largest shareholders as per the end of September, together with the chairman of the board of directors. The “three largest shareholders” refer to the ownership grouped registered or in any other way known shareholders as per the end of September. 

The chairman of the board of directors shall as soon as possible when the information regarding the three shareholders as per the end of September is known, contact the three largest shareholders to find out whether they wish to appoint a representative to the Nomination Committee. In case one of the three largest shareholders refrain from appointing a representative, or such representative resign prior to completion of the assignment and without the shareholder who has appointed the representative appointing a new member, the chairman of the board of directors shall encourage the next owner in size (i.e. in the first place the fourth largest shareholder) to appoint a representative. The procedure shall go on until the Nomination Committee is composed of four members including the chairman of the board of directors.  

The chairman of the board of directors shall as soon as possible when the information regarding the three shareholders as per the end of September is known, contact the three largest shareholders to find out whether they wish to appoint a representative to the Nomination Committee. In case one of the three largest shareholders refrain from appointing a representative, or such representative resign prior to completion of the assignment and without the shareholder who has appointed the representative appointing a new member, the chairman of the board of directors shall encourage the next owner in size (i.e. in the first place the fourth largest shareholder) to appoint a representative. The procedure shall go on until the Nomination Committee is composed of four members including the chairman of the board of directors.  

The members of the Nomination Committee shall be announced no later than six months before the annual shareholders’ meeting. When significant changes in the ownership occur after the date the Nomination Committee was appointed, the Nomination Committee may, if it considers it necessary, decide to offer a new owner a position in the Nomination Committee in accordance with the principles above. Changes in the Nomination Committee shall be made public immediately. 

The Nomination Committee’s term shall run until such time as a new Nomination Committee has been elected. 

No fees shall be paid to the members of the Nomination Committee. 

The Nomination Committee shall prepare and propose the following to the coming annual shareholders’ meeting:

(a) election of chairman at the shareholders’ meeting; 

(b) election of chairman of the board of directors and other members of the board of directors; 

(c) fees to the board of directors, divided between the chairman and other members, and any fees for committee work; 

(d) election of auditor and fees to the auditor; and 

(e) principles for appointment of the Nomination Committee.

Item 13: Determination of Remuneration Policy for senior executives

The board of directors proposes to the annual shareholders’ meeting that the following guidelines for remuneration to senior executives are adopted. 

The company shall offer remuneration levels and employment terms at market terms, aimed at facilitating the recruitment and retention of senior executives with high competence and capacity, in order to achieve established targets. It is noted that the company is highly international with employees in several countries. When determining the remuneration level and other employment terms, the starting point should be that the terms should be competitive considering the situation in the country in which the employee is employed. The guidelines shall apply to employment agreements entered into after the adoption of these guidelines by the shareholders’ meeting or amendments to existing agreements made after the adoption of the guidelines.  

The remuneration to the CEO and other senior executives can be comprised of fixed salary, variable remuneration, pension benefits, share-based incentive programs resolved by the shareholders’ meeting and other benefits. Senior executives refer to the CEO and the other persons forming part of the company’s management team.   

Remuneration and other employment terms for the CEO and other senior executives are prepared by the Remuneration Committee and resolved by the board of directors.  

The fixed salary shall take into consideration the individual’s competence, area of responsibility and performance. A review should generally be made annually.

The variable remuneration is to be based on the outcome of predetermined well defined objectives. The variable consideration is to be limited and may not exceed 75 per cent of the fixed annual salary for the CEO and 40 per cent of the fixed annual salary for other senior executives, whereby the individual highest level should be based on factors such as the position held by the specific individual. 

The company’s commitments in reference to variable remuneration for the CEO and other senior executives who can be entitled to variable remuneration targets are for 2018 calculated to amount to, if all targets are met in full and based on the current exchange rates, at the highest approximately SEK 10 million (excluding social charges). The calculation is based on the persons currently being senior executives and who can be entitled to variable remuneration.  

In addition to what follows from law or collective bargain agreements or other agreements, the CEO and other senior executives may be entitled to arrange individual pension schemes. Refrained salaries and variable remuneration can be used for increased pension contributions, provided that the total cost for the company is unchanged over time. 

Share-based incentive programs shall, where applicable, be resolved by the shareholders’ meeting.  

The senior executives may be awarded other customary benefits, such as a company car, occupational health services, etc.

In case of termination of the CEO’s employment by the company, the notice period should not exceed 6 months. In case the Company terminates the CEO without cause the CEO shall, in addition to salary during the notice period, be entitled to severance payment corresponding to 12 months’ base salary. The notice period for other senior executives shall not exceed 12 months. In case of termination from the company, in addition to salary during the notice period, severance payment corresponding to an amount equal to up to 12 months base salary may be paid.  

At the time of the annual shareholders’ meeting on 22 May 2018, the company has no outstanding remuneration commitments towards senior executives except for running commitments. 

To the extent that a member of the board of directors performs consultancy work on behalf of the company, in addition to the assignment as member of the board of directors, consultancy fees and other remuneration for such consultancy work should be payable. Such remuneration shall be paid on market terms and the remuneration as well as other terms shall be resolved upon by the board of directors. 

The board of directors shall be entitled to deviate from the guidelines in individual cases if there are special reasons for doing so.

Item 14: Resolution on implementation of a long-term incentive program for senior executives by way of (A) directed issue of warrants; and (B) approval of transfer of warrants 

The board of directors proposes that the annual shareholder’s meeting resolves to implement a long-term incentive program for senior executives (the ”Warrants Program 2018/2021”). 

To implement the Warrants Program 2018/2021, the board of directors proposes that the annual shareholders’ meeting resolves on (A) directed issue of warrants; and (B) approval of transfer of warrants, on the following terms and conditions:

A. Directed issue of warrants 

A maximum of 1,175,000 warrants shall be issued for the Warrants Program 2018/2021.

With deviation from the shareholders’ preferential rights, the right to subscribe for the warrants shall only vest in a wholly owned subsidiary within the group (the “Subsidiary”). The reason for the deviation from the shareholders’ preferential rights is that the warrants shall be used within the Warrants Program 2018/2021.  

The Subsidiary’s subscription shall be made at the latest on 30 June 2018, with a right for the board of directors to prolong the subscription period. 

Over subscription cannot occur.

The warrants shall be issued to the Subsidiary free of charge. The reason for the warrants being issued to the Subsidiary free of charge is that the warrants are issued as part of the implementation of the Warrants Program 2018/2021. 

Each warrant shall entitle to subscription of one new ordinary share in the company. 

The subscription price per share shall correspond to 125 per cent of the volume weighted average price according to Nasdaq Stockholm’s official price list for shares in the company during the period as from 14 May 2018 to and including 18 May 2018. The subscription price shall be rounded to the nearest whole öre, whereupon 0.5 öre shall be rounded upwards. 

Subscription of shares by virtue of the warrants may be effected as from 1 June 2021 up to and including 30 June 2021. 

A share that has been issued upon subscription will entitle to dividends for the first time on the first record date for dividend occurring after subscription of shares through exercise of warrants has been executed. 

The subscription price and the number of shares that each warrant confers right to subscribe for shall be subject to recalculation in consequence of a bonus issue, split, rights issue, and/or other similar company actions. 

In case all warrants are exercised for subscription of new shares, the share capital will increase with SEK 734,375. 

The chairman of the board of directors, or anyone appointed by him, shall be authorized to make minor formal adjustments of the resolution which may be required for registration with the Swedish Companies Registration Office (Sw. Bolagsverket) or Euroclear Sweden AB. 

B. Transfer of warrants 

The Warrants Program 2018/2021 shall principally be carried out in accordance with what is stated below. 

The Subsidiary shall be entitled to transfer warrants against payment to participants in the Warrants Program 2018/2021 in accordance with the guidelines set out below. 

Transfer of warrants to participants in the Warrants Program 2018/2021 shall be made at fair market value at the time of the transfer which shall be established by Öhrlings Pricewaterhouse Coopers AB, as an independent valuation institute, in accordance with the Black Scholes formula. 

The board of directors of the company shall resolve upon allotment to participants in the Warrants Program 2018/2021 in accordance with the following guidelines: 

Position

Number of warrants

CEO

A maximum of 500,000 warrants

Other senior executives (9 persons)

A maximum of 75,000 warrants per person

Allotment to the participants in the Warrants Program 2018/2021 shall occur no later than on 30 June 2018.

A participant can subscribe for a lower number of warrants compared to what is offered to the participant. Over subscription cannot occur.  

Right to allotment in the Warrants Program 2018/2021 requires that the participant at the time of allotment holds a position in the company (or another company in the group) or has signed an agreement regarding it and has not, at such time, informed or been informed that the employment will be terminated. 

For participants in other jurisdictions than Sweden, it is implied that transfer of the warrants is legally possible and that transfer, in the board of director’s opinion, can be carried out with reasonable administrative and financial efforts at the established market value of the warrants. The board of directors shall have the right to adjust the terms of the Warrants Program 2018/2021 to the extent required in order for allotment of warrants to participants in other jurisdictions, to the extent practically possible, to be carried out under the same conditions imposed by the Warrants Program 2018/2021. 

Reasons for the Warrants Program 2018/2021 and the deviation from the shareholders’ preferential rights

The reasons for the implementation of the Warrants Program 2018/2021 and the deviation from the shareholders’ preferential rights for subscription of the new warrants are to be able to create possibilities for the company to retain senior executives by offering a long term ownership engagement. Such ownership engagement is expected to contribute to an increased alignment of interests between the participating senior executives and the shareholders, and also promote a long-term commitment to the company’s development.

Costs, impact on key ratios, existing incentive programs and dilution 

Since the warrants in the Warrants Program 2018/2021 will be transferred to the participants at market value, the company’s assessment is that the company will not incur any social costs in relation to the Warrants Program 2018/2021. The company’s costs related to the Warrants Program 2018/2021 will hence only be composed of limited costs for implementation and administration of the program.

As per the date of the notice, the number of shares in the company amounts to 50,811,866. In addition thereto, warrants have been issued in connection with a previous financing agreement which could result in a maximum of 599,114 additional shares being issued. 

In case all warrants issued in connection with the Warrants Program 2018/2021 are exercised for subscription of new shares, a total of 1,175,000 new shares will be issued, which corresponds to a dilution of approximately 2.26 per cent of the company’s share capital and votes after full dilution, calculated on the number of shares that will be added upon full utilization of all warrants issued under the Warrants Program 2018/2021. The key figure earnings per share for the full year 2017 had then been changed in such way that the result per share had been changed from SEK – 3.24 to SEK –3.14. The dilution calculation as described above does not consider the shares that may be issued in connection with an exercise of the warrants which have been issued in connection with the previous financing agreement. In case these warrants are to be considered as well, the maximum total dilution from the Warrants Program 2018/2021 amounts to approximately 2.23 per cent.

There are currently incentive programs in the form of three employee option programs and one warrant program outstanding in the company. In case all warrants issued in connection with the outstanding programs, and which still can be exercised, are exercised for subscription of new shares, a total amount of 2,564,710 new shares will be issued. In addition to the Warrants Program 2018/2021, the board of directors has also proposed that the annual shareholders’ meeting resolves to implement a long-term incentive program for employees in the form of a performance-based share saving program in connection with which a total of 500,000 new shares may be issued and the Nomination Committee has proposed that the annual shareholders’ meeting also resolves to implement a long-term incentive program for certain members of the board of directors in the form of a performance-based share saving program in connection with which a total of 120,000 new shares may be issued. In case all outstanding incentive programs as well as the incentive programs proposed for resolution by the annual shareholders’ meeting are exercised in full, a total of 4,359,710 new shares will be issued, which corresponds to a total dilution of approximately 7.90 per cent of the company’s share capital and votes after full dilution, calculated on the number of shares that will be added upon full utilization of all outstanding and proposed incentive programs. The dilution calculation as described above does not consider the shares that may be issued in connection with an exercise of the warrants which have been issued in connection with the previous financing agreement. In case these warrants are to be considered as well, the maximum total dilution from existing and proposed incentive programs amounts to approximately 7.82 per cent.

The above calculations regarding dilution and impact on key ratios are subject to re-calculation of the warrants in accordance with the customary recalculation terms set out for the programs. 

Preparation of the proposal 

The proposal of the Warrants Program 2018/2021 has been prepared by the Remuneration Committee with advice from external consultants. The final proposal has been resolved by the board of directors.

Item 15: Resolution on amendment of the Articles of Association 

The board of directors of proposes that the annual shareholders’ meeting resolves, in order to enable issuance of series C shares under share saving programs, to incorporate a new § 6 in the company’s Articles of Association in accordance with the following wording. Following the incorporation of the new section in the Articles of Association, the already existing shares shall be ordinary shares.

“6 § Classes of shares 

Shares may be issued in two classes, ordinary shares and series C shares. The ordinary shares shall carry one vote per share and series C shares shall carry one-tenth of a vote per share. Shares of either share class may be issued up to an amount corresponding to the full share capital. 

Series C shares do not entitle to dividends. Upon the dissolution of the company, series C shares shall carry equivalent right to the company’s assets as other shares, however, not to an amount exceeding the quota value of the share. 

If the company resolves to issue new ordinary shares and series C shares, against payment other than contribution in kind, owners of ordinary shares and series C shares shall have pre-emption rights to subscribe for new shares of the same class pro rata to the number of shares previously held by them (primary pre-emption right). Shares which are not subscribed for pursuant to the primary pre-emption rights shall be offered to all shareholders for subscription (secondary preemption right). If the shares thus offered are not sufficient for the subscription pursuant to the secondary pre-emption rights, the shares shall be allocated between the subscribers pro rata to the number of shares previously held and, to the extent such allocation cannot be effected, by the drawing of lots.

If the company resolves to issue new shares of either solely ordinary shares or series C shares, against payment other than contribution in kind, all shareholders shall, irrespective of whether their shares are ordinary shares or series C shares, have pre-emption rights to subscribe for new shares pro rata to the number of shares previously held by them. 

What is set out above with regard to pre-emption rights shall apply mutatis mutandis in the event of issues of warrants and convertible bonds, and shall not limit the right to resolve upon an issue with deviation from the shareholders’ pre-emption rights. 

In the event of a bonus issue, new shares of each class shall be issued pro rata to the number of shares of the same class previously issued. In connection therewith, the owners of existing shares of a certain class shall entitle the holder to new shares of the same class. This shall not entail any restrictions on the possibility of issuing new shares of a new class by means of a bonus issue, following the required amendments of the Articles of Association. 

Reduction of share capital, which in any case shall not fall below the minimum share capital, may, at the request of a holder of a series C share and after resolution by the company’s board of directors or a shareholders’ meeting, take place through redemption of series C shares. A request from a shareholder must be submitted in writing. When a resolution on reduction has been passed, an amount corresponding to the reduction amount shall be transferred to the company’s reserve fund, if the required funds are available. The redemption amount per series C share shall be the quota value of such share. 

Following receipt of the redemption resolution, holders of shares subject to redemption shall promptly receive payment for the shares, or, if authorization for the redemption from the Swedish Companies Registration Office (Sw. Bolagsverket) or a court is required, following the receipt of notice that the final and effected resolution has been registered. 

Series C shares held by the company may, upon resolution of the board of directors be reclassified into ordinary shares. Immediately thereafter, the board of directors shall register the reclassification with the Swedish Companies Registration Office. The reclassification is effected when it has been registered and the reclassification been reflected in the central securities depository register.”

As a result of the incorporation of the new section, the existing sections 6 – 11 of the Articles of Association will be renumbered. 

Item 16: Resolution on implementation of a long-term incentive program for employees by way of (A) implementation of a performance-based share saving program; (B) authorization on directed issues of series C shares; (C) authorization on repurchase of series C shares; and (D) resolution on transfer of own ordinary shares 

The board of directors proposes that the annual shareholder’s meeting resolves to implement a long-term incentive program in the form of a performance-based share saving program (the “LTI 2018”) for employees in accordance with A below. The resolution shall be conditional upon that the annual shareholders’ meeting also resolves to amend the Articles of Association in accordance with a separate proposal whereby the possibility to issue series C shares is introduced and that the annual shareholders’ meeting also resolves on hedging measures in accordance with B – D below.

A. Implementation of a performance-based share saving program 

Background 

The overall purpose with LTI 2018 is to align the interests of the employees with those of the shareholders and thus ensure a maximum long-term value adding commitment. LTI 2018 is also considered to create a long-term focus on increase in earnings and growth among the participants. LTI 2018 is further considered to facilitate for the company to recruit and retain employees.

Terms and conditions for LTI 2018 

As a starting point, LTI 2018 shall comprise employees who do not participate in any outstanding share-related incentive programs in the company prior to the annual shareholders’ meeting on 22 May 2018. However, the company’s CFO shall have the right to participate in LTI 2018 even though he is a participant in a share-related incentive program since previously, and the board of directors may in addition to that, in exceptional cases, also resolve that up to five employees in the category “Other employees” who participate in share-related incentive programs since previously shall be entitled to participate in LTI 2018. 

In total, LTI 2018 is considered to comprise up to approximately 25 employees. In order to be entitled to participate in LTI 2018, it is required that the participant has been employed by the company or another company within the Group at the latest on the date of expiration of the Investment Period in accordance with the below. 

LTI 2018 means that the participants will invest in ordinary shares in the company (”Saving Shares”). In order to be entitled to participate in LTI 2018, each participant must at least acquire the number of Savings Shares which has been specified for each category below (which amount also corresponds to the maximum number of Saving Shares that each participant in each category may acquire within the framework of LTI 2018). The investment in Saving Shares shall be made through acquisition of ordinary shares on the stock market on 31 December 2018 at the latest (the "Investment Period").

If the Saving Shares are retained as from the expiration of the Investment Period to and including 31 December 2021 (the “Saving Period”) and the participant has continued to be employed by the company throughout the Saving Period, the participant is entitled to allotment of additional ordinary shares in the company free of charge (the “Performance Shares”), provided that the performance targets (the “Performance Targets”) mentioned below are achieved or exceeded. 

Participants shall acquire the following number of Saving Shares and shall have the opportunity to be allotted with up to the following number of Performance Shares per Saving Share. 

Position

Number of Saving Shares

Maximum number of Performance Shares per Saving Share

CEO

30,000

4

Other senior executives (4 persons)

15,000

3

Other employees (approximately 20 persons)

5,000

2

The total number of Performance Shares shall not exceed 500,000.  

The Performance Targets that have to be achieved or exceeded relate to (i) the share price development of the company’s shares (the “Share Price Target”), (ii) the net sales for each respective financial year of 2018-2021 (the “Sales Target”), and (iii) the EBITDA for each respective financial year of 2018-2021 (the “EBITDA Target”), whereby each Performance Target is weighted by 1/3 and with regard to the Sales Target and EBITDA Target, each respective financial year is weighted by 1/4.

The Share Price Target relates to the development of the company’s share price over the period from the date of the annual shareholders’ meeting 2018 to and including 31 December 2021. The share price development will be measured based on the volume weighted average share price 30 trading days immediately following the annual general meeting 2018 and 30 trading days immediately preceding 31 December 2021. An increase in the share price with less than 25 per cent does not entitle to any vesting of any of the Performance Shares pertaining to the Share Price Target and an increase in the share price with 100 per cent or more does entitle a vesting of all of the Performance Shares pertaining to the Share Price Target. In the event of an increase in the share price of between 25 and 100 per cent, vesting of the Performance Shares pertaining to the Share Price Target will occur linearly. 

The Sales Target and the EBITDA Target for each respective financial year shall be determined by the board of directors annually and with regard to the financial year 2018, before LTI 2018 is of fered to the participants. For each respective target, a minimum level and a maximum target level shall be determined for each respective financial year. If the minimum level is not achieved, no Performance Shares are vested in relation to the actual Performance Target for the financial year and if the maximum target level is achieved, full vesting shall take place of the Performance Shares pertaining to the actual Performance Target for the financial year. If the minimum level is exceeded but the maximum target level is not achieved, vesting of the Performance Shares pertaining to the actual Performance Target for the financial year will occur linearly. The board of directors intends to present the determined targets regarding the Sales Target and the EBITDA Target as well as the achievement of these in connection with the expiration of LTI 2018 at the latest.

The final number of Performance Shares vested by each participant shall be rounded downwards to the nearest whole number. 

Before the number of Performance Shares to be allocated is finally determined, the board of directors shall evaluate if allocation pursuant to the principles set out above is reasonable, having regard to the company’s results and financial standing, to conditions on the stock market and to other circumstances in general. If the board of directors finds that it is not reasonable, then the board of directors may decrease the number of Performance Shares to be allocated to the lower number of shares that the board of directors finds reasonable. 

The number of Performance Shares that may be allotted by virtue of Saving Shares shall be subject to recalculation in consequence of a bonus issue, split, rights issue, and/or other similar company actions.

Allotment of Performance Shares shall take place within 30 days from the publication of the yearend report for the financial year 2021. 

Participation in LTI 2018 presupposes that the participation is legally possible and that the participation in the company’s sole opinion can be made with reasonable administrative costs for the company.

The board of directors shall be responsible for the details and management of LTI 2018 within the framework of the main conditions as set out above, and the board of directors shall be authorized to make minor adjustments to these conditions as required by law or for administrative reasons. The board of directors shall also be authorized to adjust or deviate from the terms and conditions as required by local laws and regulations as well as existing market practices. Furthermore, in the event of a public take-over offer, a sale of the company’s business, liquidation, merger or any other such transaction affecting the company, the board of directors shall, at its sole discretion, be entitled to resolve that the Performance Shares (partially or in full) shall vest and be allotted on completion of such transaction. The board of directors will make this resolution based on the level of achievement of the Performance Targets, the remainder of the Saving Period and any other factors deemed relevant by the board of directors.

B. Authorization on directed issues of series C shares 

The board of directors proposes that the annual shareholders’ meeting resolves to authorize the board of directors, for the period up until the next annual shareholders’ meeting, on one or several occasions, to issue a maximum of 500,000 series C shares. The new shares may, with deviation from the shareholders' preferential rights, only be subscribed for by a bank or a securities company at a subscription price which corresponds to the quota value of the shares. The purpose of the authorization and the reason for the deviation from the shareholders' preferential rights in connection with an issue of shares is to secure delivery of Performance Shares under LTI 2018, which shall be effected through the company repurchasing the series C shares issued pursuant to the authorization in section C below and thereafter, when the series C shares have been converted to ordinary shares, by transferring ordinary shares to the participants in LTI 2018 in accordance with section D below. 

C. Authorization on repurchase of series C shares

The board of directors proposes that the annual shareholders’ meeting resolves to authorize the board of directors, for the period up until the next annual shareholders’ meeting, on one or several occasions, to repurchase its own series C shares. Repurchase may only be effected through a public offer directed to all holders of series C shares and shall comprise all outstanding series C shares. Repurchase may also be made of so-called interim shares, by Euroclear Sweden AB designated as a Paid Subscribed Share (Sw. Betald Tecknad Aktie (BTA)), regarding a series C share. Repurchase shall be made at a purchase price per share which corresponds to the quota value of the share. The purpose of the proposed repurchase authorization is to secure delivery of Performance Shares under LTI 2018.

D. Resolution on transfer of own ordinary shares

In order to fulfil the company’s obligations towards participants in LTI 2018, the board of directors proposes that the annual shareholders’ meeting resolves that the company shall be entitled to transfer the company’s own ordinary shares as follows: 

The company shall have the right to transfer the number of ordinary shares that the Company has a maximum obligation to allocate as Performance Shares to participants in LTI 2018, at most 500,000 shares. 

The number of shares that may be transferred pursuant to LTI 2018 shall be subject to recalculation in consequence of a bonus issue, split, rights issue, and/or other similar corporate action which affects the number of shares in the company. 

The right to acquire ordinary shares shall, with deviation from the shareholders’ preferential rights, vest in participants in LTI 2018 who are entitled to be allotted Performance Shares in accordance with the terms and conditions of the program. 

Transfer of shares to participants in LTI 2018 shall be made free of charge and be executed at the relevant time specified in the terms and conditions for LTI 2018. 

The reason for the deviation from the shareholders' preferential rights in connection with the transfers of own ordinary shares is to enable the company’s delivery of Performance Shares to participants in LTI 2018. 

Costs, impact on key ratios, existing incentive programs and dilution 

LTI 2018 will be accounted for in accordance with IFRS 2 which stipulates that the right to receive Performance Shares shall be expensed as a personnel cost over the vesting period.

The board of directors has made a preliminary cost calculation for LTI 2018, which is based on a price per share of SEK 30 at the final allocation, that each participant makes an investment in Saving Shares which qualifies for participation in LTI 2018 and that the maximum number of Performance Shares is allotted. The value of the Performance Shares has been calculated based on a share price of SEK 15 per share in connection with the implementation of LTI 2018. Based on the above assumptions, the value of each Performance Share related to the Sales Target and the EBITDA Target, respectively has been calculated to SEK 15 and the value of each Performance Share related to the Share Price Target has been calculated to SEK 5.67. 

Overall, this results in a maximum cost for LTI 2018 of approximately SEK 5.9 million, excluding costs for social security contributions. The total costs for social security contributions, based on the assumption of a 100 per cent share price increase until the time of allocation of Performance Shares, is estimated to amount to a maximum of approximately SEK 4.7 million.

As per the date of the notice, the number of shares in the company amounts to 50,811,866. In addition thereto, warrants have been issued in connection with a previous financing agreement which could result in a maximum of 599,114 additional shares being issued. 

The maximum number of Performance Shares amounts to 500,000, which corresponds to a dilution of approximately 0.97 per cent of the company’s share capital and votes after full dilution, calculated on the number of shares that will be added upon full issuance of Performance Shares in connection with LTI 2018. 

Based on the calculation of cost and the dilution as per the above, the key figure earnings per share for the full year 2017 had been changed from SEK –3.24 to SEK –3.28. 

The dilution calculation as described above does not consider the shares that may be issued in connection with an exercise of the warrants which have been issued in connection with the previous financing agreement. In case these warrants are to be considered as well, the maximum total dilution from LTI 2018 amounts to approximately 0.96 per cent.

Information on existing incentive programs and dilution effects are presented above in the proposal under item 14. 

Preparation of the proposal 

The proposal for LTI 2018 has been prepared by the Remuneration Committee together with external consultants. The final proposal has been resolved upon by the board of directors. 

Item 17: Resolution on implementation of a long-term incentive program for certain members of the board of directors by way of (A) implementation of a performance-based share saving program; (B) authorization on directed issues of series C shares; (C) authorization on repurchase of series C shares; and (D) resolution on transfer of own ordinary shares 

The Nomination Committee proposes that the annual shareholder’s meeting resolves to implement a long-term incentive program in the form of a performance-based share saving program (the “Board LTI 2018”) for certain members of the board of directors in accordance with A below. The resolution shall be conditional upon that the annual shareholders’ meeting also resolves to amend the Articles of Association in accordance with a separate proposal whereby the possibility to issue series C shares is introduced and that the annual shareholders’ meeting also resolves on hedging measures in accordance with B – D below.

A. Implementation of a performance-based share saving program 

Background

Board LTI 2018 has been initiated and prepared by the Nomination Committee, considering that the company competes for qualified board members in an internationally competitive market. The overall purpose with Board LTI 2018 is to align the interests of the members of the board of directors with those of the shareholders and thus ensure a maximum long-term value adding commitment. Board LTI 2018 is also considered to create a long-term focus on increase in earnings and growth among the participants.

Terms and conditions for Board LTI 2018 

Board LTI 2018 shall comprise the members of the board of directors, Simon Cartmell, Tone Kvåle and Lennart Johansson. The members of the board of directors, Håkan Björklund, Björn Odlander and Nina Rawal, who are linked to the company’s principal shareholders Tellacq AB, HealthCap V L.P. and Stiftelsen Industrifonden, and the member of the board of directors, Lars Lidgren, who is the founder of the company, shall not be comprised of Board LTI 2018. 

Board LTI 2018 means that the participants will invest in ordinary shares in the company (”Saving Shares”). In order to be entitled to participate in Board LTI 2018, each participant must at least acquire the number of Savings Shares which has been specified for each participant below (which amount also corresponds to the maximum number of Saving Shares that each participant may acquire within the framework of Board LTI 2018). The investment in Saving Shares shall be made through acquisition of ordinary shares on the stock market on 31 December 2018 at the latest (the "Investment Period").

If the Saving Shares are retained as from the expiration of the Investment Period to and including 31 December 2021 and the participant has continued to be a member of the board of directors of the company until the date of when the annual shareholders’ meeting 2021 is held (i.e. most likely in May 2021), the participant is entitled to allotment of additional ordinary shares in the company free of charge (the “Performance Shares”), provided that the performance target (the “Performance Target”) mentioned below is achieved or exceeded. 

Participants shall acquire the following number of Saving Shares and shall have the opportunity to be allotted with up to the following number of Performance Shares per Saving Share. 

Participant

Number of Saving Shares 

Maximum number of Performance Shares per Saving Share

Simon Cartmell

30,000

2

Tone Kvåle and Lennart Johansson

15,000

2

The total number of Performance Shares shall not exceed 120,000. 

The Performance Target that has to be achieved or exceeded relates to the development of the company’s share price over the period from the date of the annual shareholders’ meeting 2018 to and including 31 December 2021. The share price development will be measured based on the volume weighted average share price 30 trading days immediately following the annual general meeting 2018 and 30 trading days immediately preceding 31 December 2021. An increase in the share price with less than 25 per cent does not entitle to any vesting of Performance Shares and an increase in the share price with 100 per cent or more does entitle a vesting of all Performance Shares. In the event of an increase in the share price of between 25 and 100 per cent, vesting of Performance Shares will occur linearly. 

The final number of Performance Shares vested by each participant shall be rounded downwards to the nearest whole number. 

The number of Performance Shares that may be allotted by virtue of Saving Shares shall be subject to recalculation in consequence of a bonus issue, split, rights issue, and/or other similar company actions.

Allotment of Performance Shares shall take place within 30 days from the publication of the yearend report for the financial year 2021. 

Participation in Board LTI 2018 presupposes that the participation is legally possible and that the participation in the company’s sole opinion can be made with reasonable administrative costs for the company. 

The company’s Remuneration (excluding the participants, if applicable) shall be responsible for the management of Board LTI 2018 within the framework of the conditions as set out above, and the board of directors shall be authorized to make minor adjustments to these conditions as required by law or for administrative reasons. The Remuneration Committee shall also be responsible for any recalculations in accordance with the above. 

In the event of a public take-over offer, a sale of the company’s business, liquidation, merger or any other such transaction, all Performance Shares shall be deemed to be immediately vested and shall be allotted on completion of such transaction provided that the participant at the relevant point of time of such transaction (i) still is a member of the board of directors; and (ii) still holds all Saving Shares. 

B. Authorization on directed issues of series C shares  

The Nomination Committee proposes that the annual shareholders’ meeting resolves to authorize the board of directors, for the period up until the next annual shareholders’ meeting, on one or several occasions, to issue a maximum of 120,000 series C shares, wherein the final number of series C shares that may be issued shall be determined to correspond with the maximum amount of Performance Shares that may need to be issued in relation to Board LTI 2018. The new shares may, with deviation from the shareholders' preferential rights, only be subscribed for by a bank or a securities company at a subscription price which corresponds to the quota value of the shares. The purpose of the authorization and the reason for the deviation from the shareholders' preferential rights in connection with an issue of shares is to secure delivery of Performance Shares under Board LTI 2018, which shall be effected through the company repurchasing the series C shares issued pursuant to the authorization in section C below and thereafter, when the series C shares have been converted to ordinary shares, by transferring ordinary shares to the participants in Board LTI 2018 in accordance with section D below. 

C. Authorization on repurchase of series C shares 

The Nomination Committee proposes that the annual shareholders’ meeting resolves to authorize the board of directors, for the period up until the next annual shareholders’ meeting, on one or several occasions, to repurchase its own series C shares. Repurchase may only be effected through a public offer directed to all holders of series C shares and shall comprise all outstanding series C shares. Repurchase may also be made of so-called interim shares, by Euroclear Sweden AB designated as a Paid Subscribed Share (Sw. Betald Tecknad Aktie (BTA)), regarding a series C share. Repurchase shall be made at a purchase price per share which corresponds to the quota value of the share. The purpose of the proposed repurchase authorization is to secure delivery of Performance Shares under Board LTI 2018. 

D. Resolution on transfer of own ordinary shares

In order to fulfil the company’s obligations towards participants in Board LTI 2018, the Nomination Committee proposes that the annual shareholders’ meeting resolves that the company shall be entitled to transfer the company’s own ordinary shares as follows:

The company shall have the right to transfer the number of ordinary shares that the company has a maximum obligation to allocate as Performance Shares to participants in Board LTI 2018, at most 120,000 shares. 

The number of shares that may be transferred pursuant to Board LTI 2018 shall be subject to recalculation in consequence of a bonus issue, split, rights issue, and/or other similar corporate action which affects the number of shares in the company. 

The right to acquire ordinary shares shall, with deviation from the shareholders’ preferential rights, vest in participants in Board LTI 2018 who are entitled to be allotted Performance Shares in accordance with the terms and conditions of the program. 

Transfer of shares to participants in Board LTI 2018 shall be made free of charge and be executed at the relevant time specified in the terms and conditions for Board LTI 2018. 

The reason for the deviation from the shareholders' preferential rights in connection with the transfers of own ordinary shares is to enable the company’s delivery of Performance Shares to participants in Board LTI 2018. 

Costs, impact on key ratios, existing incentive programs and dilution 

Board LTI 2018 will be accounted for in accordance with IFRS 2 which stipulates that the right to receive Performance Shares shall be expensed as a personnel cost over the vesting period. 

The Nomination Committee has made a preliminary cost calculation for Board LTI 2018, which is based on a price per share of SEK 30 at the final allocation, that each participant makes an investment in Saving Shares which qualifies for participation in Board LTI 2018 and that the maximum number of Performance Shares is allotted. The value of the Performance Shares has been calculated based on a share price of SEK 15 per share in connection with the implementation of Board LTI 2018. Based on the above assumptions, the value of each Performance Share has been calculated to SEK 5.67.

Overall, this results in a maximum cost for Board LTI 2018 of approximately SEK 0.7 million, excluding costs for social security contributions. The total costs for social security contributions, based on the assumption of a 100 per cent share price increase until the time of allocation of Performance Shares, is estimated to amount to a maximum of approximately SEK 1.1 million. 

As per the date of the notice, the number of shares in the company amounts to 50,811,866. In addition thereto, warrants have been issued in connection with a previous financing agreement which could result in a maximum of 599,114 additional shares being issued. 

The maximum number of Performance Shares amounts to 120,000, which corresponds to a dilution of approximately 0.24 per cent of the company’s share capital and votes after full dilution, calculated on the number of shares that will be added upon full issuance of Performance Shares in connection with Board LTI 2018. 

Based on the calculation of cost and the dilution as per the above, the key figure earnings per share for the full year 2017 would have been unchanged. 

The dilution calculation as described above does not consider the shares that may be issued in connection with an exercise of the warrants which have been issued in connection with the previous financing agreement. In case these warrants are to be considered as well, the maximum total dilution from Board LTI 2018 amounts to approximately 0.23 per cent. 

Information on existing incentive programs and dilution effects are presented above in the proposal under item 14. 

Preparation of the proposal 

The proposal for Board LTI 2018 has been prepared by the Nomination Committee together with external consultants. However, the chairman of the board of directors, Håkan Björklund, has not participated in the Nomination Committee’s preparation of the proposal.  

Particular majority requirements 

For a valid resolution on the proposal pursuant to item 15, the proposal has to be supported by shareholders representing at least two-thirds of the votes cast as well as of all shares represented at the annual shareholders’ meeting. For a valid resolution on the proposals pursuant to items 14, 16 and 17, the proposals have to be supported by shareholders representing at least nine-tenths of the votes cast as well as of all shares represented at the annual shareholders’ meeting. 

Duty of disclosure at the annual shareholders' meeting

The board and the CEO shall at the annual shareholders’ meeting, if any shareholder so requests and the board believes that it can be done without significant harm to the company, provide information regarding circumstances that may affect the assessment of items on the agenda, circumstances that can affect the assessment of the company’s or its subsidiaries financial position and the company’s relation to other companies within the group.

Accounting documents and complete proposals 

Accounting documents, the audit report, the statement by the auditor on the compliance of the applicable guidelines for remuneration to senior executives as well as complete proposals for resolutions and the board of directors’ statement pursuant to Chapter 19, Section 22 of the Swedish Companies Act will be made available for the shareholders at the company’s office at Scheelevägen 19, SE-223 70 Lund, Sweden and at the company website (bonesupport.com) as from no later than three weeks prior to the annual shareholders’ meeting. Copies of the documents will be sent to the shareholders upon their request to the company, provided that such shareholders state their address, and will also be made available at the annual shareholders’ meeting. 

Number of shares and votes in the company 

As per the date of this notice, the total number of shares and votes in the company amounts to 50,811,866. The company does not hold any own shares.

 

About BONESUPPORTTM

BONESUPPORT is an innovative and rapidly growing commercial stage orthobiologics company, based in Lund, Sweden. The Company develops and commercializes innovative injectable bio-ceramic bone graft substitutes that remodel to the patient’s own bone and have the capability of eluting drugs directly into the bone void.

BONESUPPORT’s marketed bio-ceramic bone graft substitutes CERAMENT® BONE VOID FILLER (BVF),  CERAMENT® G* and CERAMENT® V* are all based on the Company’s novel and proprietary CERAMENT  technology platform.

The Company’s products are targeting a large addressable market opportunity across trauma, chronic osteomyelitis (bone infection), revision arthroplasty (replacement of a joint prosthesis) and infected diabetic foot. BONESUPPORT’s total sales increased from SEK 62 million in 2015 to SEK 129 million in 2017, representing a compound annual growth rate of 45 percent. The Company’s financial target is to achieve revenue exceeding SEK 500 million in the financial year 2020, with a gross margin exceeding 85 percent and a positive operating profit.

The Company’s research and development is focused on the continuing development and refinement of its CERAMENT technology to extend its use into additional indications by the elution of other drugs and  therapeutic agents. The Company currently has a pipeline of pre-clinical product candidates that have been designed to promote bone growth.

BONESUPPORT is listed on Nasdaq Stockholm and trades under the ticker “BONEX” (ISIN code: SE0009858152). Further information is available at bonesupport.com

*CERAMENT G: Not available in the United States, for investigational use only. CERAMENT V: Not available in the United States 

BONESUPPORT™ and CERAMENT® are registered trademarks

For more information contact:

Emil Billbäck, CEO

Tel: +46 (0) 46 286 53 70 

 

Björn Westberg, CFO 

Tel: +46 (0) 46 286 53 60 

Email: ir@bonesupport.com

The information was submitted for publication, through the agency of the contact persons set out above, at 13:00 CET on 20 April 2018. 

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Press release PDF (279.09 KB)

BONESUPPORT™ – Positive clinical data for CERAMENT® G in infection management presented at BLRS 2018

21st March 2018

BONESUPPORT™ – Positive clinical data for CERAMENT® G in infection management presented at BLRS 2018

Lund, Sweden, 08.00 CET, 21 March 2018 – BONESUPPORTTM, an emerging leader in innovative injectable bio-ceramic bone substitute products to treat bone voids caused by trauma, infection, disease or related surgery based on its unique CERAMENT® platform announces that three papers based on the successful use of CERAMENT® G to treat bone infections were presented at the British Limb Reconstruction Society (BLRS) Meeting 2018, which took place from the 15-16th March in Southampton.

One of the papers, entitled ‘The choice of local antibiotic carrier significantly affects outcome in treatment of chronic bone infection’ by J Ferguson, M Mifsud, D Stubbs and MA McNally, compared the use of CERAMENT® G in 160 patients with chronic bone infection (mean follow-up 1.4 years) vs the use of Osteoset® T in 137 patients with chronic bone infection (mean follow-up 2.5 years).The data presented showed that CERAMENT® G demonstrates significantly better bone healing and is associated with a lower rate of recurrent infection, wound leakage and subsequent fracture risk.

A second of the papers was ‘Internal Fixation and Local Antibiotics for Infected Non-unions; technique and outcome at over one year’ by MA McNally, J Ferguson, M Mifsud and D Stubbs. In a series of 12 cases of infected non-union and segmental bone loss up to 1cm treated by intramedullary nails/plates and CERAMENT® G, all patients were infection free at a mean follow-up of 23 months and union was achieved in 92% of patients with primary surgery alone.  

The final paper presented was ‘Outcomes of simultaneous Ilizarov frame reconstruction and free muscle flaps in the management of complex limb infection’ by M Mifsud, J Ferguson, D Stubbs, A Ramsden and MA McNally. In a series of 56 patients (34 osteomyelitis and 22 infected non-unions) treated by Ilizarov reconstruction (a type of external fixation), muscle flaps and CERAMENT® G, at a mean follow-up of 22 months, 97.7% had achieved bony union. Recurrence rate of infection in this very challenging subgroup of patients was 8.9%.

Mr Martin McNally, Consultant Bone Infection and Limb Reconstruction Surgeon at Oxford University Hospitals (Oxford, UK) and co-author on all papers presented, said: “The papers we have presented at BLRS continue to emphasise the important benefits that CERAMENT® G can provide in various bone infection situations across large numbers of patients. Its ability to prevent infection recurrence through local antibiotic delivery whilst simultaneously allowing for bone remodelling offers advantages including reduced readmission rates and number of operations for patients.”

BLRS brings together surgeons and associated professionals with the aim of advancing education and research in the field of limb reconstruction.

 

About BONESUPPORT™

BONESUPPORT is an innovative and rapidly growing commercial stage orthobiologics company, based in Lund, Sweden. The Company develops and commercializes innovative injectable bio-ceramic bone graft substitutes that remodel to the patient’s own bone and have the capability of eluting drugs directly into the bone void.

BONESUPPORT’s marketed bio-ceramic bone graft substitutes CERAMENT® BONE VOID FILLER (BVF), CERAMENT® G* and CERAMENT® V* are all based on the Company’s novel and proprietary CERAMENT technology platform.

The Company’s products are targeting a large addressable market opportunity across trauma, chronic osteomyelitis (bone infection), revision arthroplasty (replacement of a joint prosthesis) and infected diabetic foot.

BONESUPPORT’s total sales increased from SEK 62 million in 2015 to SEK 129 million in 2017, representing a compound annual growth rate of 45%. The Company’s financial target is to achieve revenue exceeding SEK 500 million in the financial year 2020, with a gross margin exceeding 85 percent and a positive operating profit.

The Company’s research and development is focused on the continuing development and refinement of its CERAMENT technology to extend its use into additional indications by the elution of other drugs and therapeutic agents. The Company currently has a pipeline of pre-clinical product candidates that have been designed to promote bone growth.

BONESUPPORT is listed on Nasdaq Stockholm and trades under the ticker “BONEX” (ISIN code: SE0009858152). Further information is available at bonesupport.com

*CERAMENT G: Not available in the United States, for investigational use only. CERAMENT V: Not available in the United States

BONESUPPORT™ and CERAMENT® are registered trademarks.

For more information contact:

Emil Billbäck, CEO

+46 (0) 46 286 53 70

Björn Westberg, CFO

+46 (0) 46 286 53 60

ir@bonesupport.com

 

Citigate Dewe Rogerson

Pip Batty, David Dible, Shabnam Bashir, Isabelle Andrews

+44 (0)20 7282 1022

bonesupport@citigatedewerogerson.com

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Press release PDF (196.93 KB)

BONESUPPORT’s New CEO Purchases Shares

13th March 2018

BONESUPPORT’s New CEO Purchases Shares

Lund, Sweden, 08.00 CET, 13 March 2018 – BONESUPPORTTM, an emerging leader in innovative injectable bio-ceramic bone substitute products to treat bone voids caused by trauma, infection, disease or related surgery based on its unique CERAMENT® platform announces that Emil Billbäck, its recently appointed Chief Executive Officer, purchased 60,000 shares in the Company at a price of SEK 15.07 per share on Friday 9 March.

Björn Westberg, the Company’s Chief Financial Officer,  bought 20,000 BONESUPPORT shares yesterday at a price of SEK 14.80 per share. Mr Westberg has purchased a total of 60,000 BONESUPPORT shares since the Company’s IPO in June 2017. In addition to his shareholding he holds warrants, which he purchased when he joined the Company in early 2017.

 

About BONESUPPORT™

BONESUPPORT is an innovative and rapidly growing commercial stage orthobiologics company, based in Lund, Sweden. The Company develops and commercializes innovative injectable bio-ceramic bone graft substitutes that remodel to the patient’s own bone and have the capability of eluting drugs directly into the bone void.

BONESUPPORT’s marketed bio-ceramic bone graft substitutes CERAMENT® BONE VOID FILLER (BVF), CERAMENT® G* and CERAMENT® V* are all based on the Company’s novel and proprietary CERAMENT technology platform.

The Company’s products are targeting a large addressable market opportunity across trauma, chronic osteomyelitis (bone infection), revision arthroplasty (replacement of a joint prosthesis) and infected diabetic foot.

BONESUPPORT’s total sales increased from SEK 62 million in 2015 to SEK 129 million in 2017, representing a compound annual growth rate of 45%. The Company’s financial target is to achieve revenue exceeding SEK 500 million in the financial year 2020, with a gross margin exceeding 85 percent and a positive operating profit.

The Company’s research and development is focused on the continuing development and refinement of its CERAMENT technology to extend its use into additional indications by the elution of other drugs and therapeutic agents. The Company currently has a pipeline of pre-clinical product candidates that have been designed to promote bone growth.

BONESUPPORT is listed on Nasdaq Stockholm and trades under the ticker “BONEX” (ISIN code: SE0009858152). Further information is available at bonesupport.com

*CERAMENT G: Not available in the United States, for investigational use only. CERAMENT V: Not available in the United States

BONESUPPORT™ and CERAMENT® are registered trademarks.

For more information contact:

Emil Billbäck, CEO

+46 (0) 46 286 53 70

 

Björn Westberg, CFO

+46 (0) 46 286 53 60

ir@bonesupport.com

 

Citigate Dewe Rogerson

Pip Batty, David Dible, Shabnam Bashir, Isabelle Andrews

+44 (0)20 7282 1022

bonesupport@citigatedewerogerson.com

Downloads

Press release PDF (121.11 KB)

BONESUPPORTTM to present at Orthopaedic Research Society (ORS) 2018 Annual Meeting

9th March 2018

BONESUPPORTTM to present at Orthopaedic Research Society (ORS) 2018 Annual Meeting

Lund, Sweden, 08.00 CET, 9 March 2018 – BONESUPPORTTM, an emerging leader in innovative injectable bio-ceramic bone substitute products to treat bone voids caused by trauma, infection, disease or related surgery based on its unique CERAMENT® platform announces that it will give two oral presentations and a poster presentation at the upcoming Orthopaedic Research Society (ORS) 2018 Annual Meeting. The meeting takes place from March 10-13 at the Hyatt Regency New Orleans in New Orleans, LA and is the leading forum for the presentation of high-quality, innovative and transformative orthopaedic research.

The research to be presented was undertaken by BONESUPPORTTM in collaboration with Lund University in Sweden.

Jerry Chang, Executive Vice President R&D, Regulatory and Clinical, commented:

“We are extremely pleased to be covering important new data via these three presentations at ORS. The data further highlights the benefits of our CERAMENT® platform due to its ability to remodel to host bone, as well as its capability to effectively deliver bone growth factors locally to aid bone formation. This research reaffirms our confidence in the potential of our preclinical pipeline, focused on exploiting the drug eluting properties of CERAMENT® based carriers, in meeting global unmet needs in both fracture repair and prevention.”

The details of the presentations are as follows:

Oral presentations

  1. Paper Title: An Injectable Calcium Sulphate/Hydroxyapatite Biomaterial Delivering rhBMP-2 and ZA for Bone Regeneration in the Femoral Canal of Osteoporotic Rats

    Authors: Aurimas Širka, Deepak Bushan Raina, Hanna Isaksson, Elizabeth Tanner, Alfredas Smailys, Šarūnas Tarasevičius, Magnus Tägil, Lars Lidgren

    Date & Time: Saturday, March 10, 2018. 3:00 PM - 3:10 PM

    Presenter: Aurimas Širka (Orthopaedic Surgeon, combined PhD program at the Lithuanian University of Health Sciences and Lund University, Sweden)

     

  2. Paper title: The Effect Of A Biphasic Apatite/Calcium Sulfate Bone Graft Substitute Conjugated With Different Dosages Of Bisphosphonate On Bone Defect Healing In Rats

    Authors: Christina Perdikouri, Eva Lidén, Michael Diefenbeck

    Date & Time: Tuesday March 13, 2018. 8:14 AM – 8:21 AM

    Presenter: Christina Perdikouri (BONESUPPORT R&D Scientist, PhD)

     

Poster presentation

Poster and paper title: In-vitro And In-vivo Carrier Properties Of A Macroporous Composite Biomaterial For Sustained Delivery Of Bone Morphogenic Protein-2 And Zoledronic Acid

Authors: Deepak Raina, David Larsson, Filip Mrkonjic, Hanna Isaksson, Ashok Kumar, Lars Lidgren, Magnus Tägil

The paper will be presented in poster session “Biomaterials – Technologies” and as a 1-minute poster teaser presentation.

 

Poster Session:

Date & Time: Monday March 12, 3:15 PM – 4:15 PM

Presenter: Deepak Raina (Department of Orthopaedics, Medical Faculty, Lund University, Sweden)

 

Poster Teaser Presentation:

Date & Time: Saturday March 10. Presentation as part of poster teaser session 2:15 PM - 3:20 PM; presentation time: 2:47pm - 2:48pm

Presenter(s): Deepak Raina (Department of Orthopaedics, Medical Faculty, Lund University, Sweden)

 

About BONESUPPORT™

BONESUPPORT is an innovative and rapidly growing commercial stage orthobiologics company, based in Lund, Sweden. The Company develops and commercializes innovative injectable bio-ceramic bone graft substitutes that remodel to the patient’s own bone and have the capability of eluting drugs directly into the bone void.

BONESUPPORT’s marketed bio-ceramic bone graft substitutes CERAMENT® BONE VOID FILLER (BVF), CERAMENT® G* and CERAMENT® V* are all based on the Company’s novel and proprietary CERAMENT technology platform.

The Company’s products are targeting a large addressable market opportunity across trauma, chronic osteomyelitis (bone infection), revision arthroplasty (replacement of a joint prosthesis) and infected diabetic foot.

BONESUPPORT’s total sales increased from SEK 62 million in 2015 to SEK 129 million in 2017, representing a compound annual growth rate of 45%. The Company’s financial target is to achieve revenue exceeding SEK 500 million in the financial year 2020, with a gross margin exceeding 85 percent and a positive operating profit.

The Company’s research and development is focused on the continuing development and refinement of its CERAMENT technology to extend its use into additional indications by the elution of other drugs and therapeutic agents. The Company currently has a pipeline of pre-clinical product candidates that have been designed to promote bone growth.

BONESUPPORT is listed on Nasdaq Stockholm and trades under the ticker “BONEX” (ISIN code: SE0009858152). Further information is available at bonesupport.com

*CERAMENT G: Not available in the United States, for investigational use only. CERAMENT V: Not available in the United States

BONESUPPORT™ and CERAMENT® are registered trademarks.

For more information contact:

Emil Billbäck, CEO

+46 (0) 46 286 53 70

 

Björn Westberg, CFO

+46 (0) 46 286 53 60

ir@bonesupport.com

 

Citigate Dewe Rogerson

Pip Batty, David Dible, Shabnam Bashir, Isabelle Andrews

+44 (0)20 7282 1022

bonesupport@citigatedewerogerson.com

Downloads

Press release PDF (147.77 KB)

BONESUPPORT™ to present at Canaccord Musculoskeletal Conference

5th March 2018

BONESUPPORT™ to present at Canaccord Musculoskeletal Conference

Lund, Sweden, 08.00 CET, 5 March 2018 – BONESUPPORTTM, an emerging leader in innovative injectable bio-ceramic bone substitute products to treat bone voids caused by trauma, infection, disease or related surgery based on its unique CERAMENT® platform announces that it will present at the Canaccord Musculoskeletal Conference on Tuesday 6 March at 10.00 am EST in New Orleans, US

Patrick O’Donnell, General Manager & Executive Vice President of Commercial Operations US, will present at the Conference. His presentation will provide an overview of the Company’s proprietary CERAMENT platform and its products which provide clear benefits to patients, surgeons and payors through their ability to remodel to host bone and to protect the healing process from infection in the case of CERAMENT® G&V*. Reducing infection rates in orthopedic surgery is a key objective in order to decrease the patient’s length of stay and the number of readmissions following the primary procedure.

The presentation will also cover recent progress made with the Company’s growth strategy which is focused on driving the sales of BONESUPPORT’s currently marketed products, generating further clinical data to drive their adoption in major indications such as trauma and revision arthroplasty and completing the FORTIFY study which is designed to support a planned Premarket Approval (PMA) filing with CERAMENT G in 2020.

BONESUPPORT™ intends to have a number of one on one investor meetings at the Canaccord Musculoskeletal Conference.

BONESUPPORT™ will also be exhibiting at the American Academy of Orthopaedic Surgeons 2018 Annual Meeting, which takes place from 6-10 March in New Orleans, US.

 

About BONESUPPORT™

BONESUPPORT is an innovative and rapidly growing commercial stage orthobiologics company, based in Lund, Sweden. The Company develops and commercializes innovative injectable bio-ceramic bone graft substitutes that remodel to the patient’s own bone and have the capability of eluting drugs directly into the bone void.

BONESUPPORT’s marketed bio-ceramic bone graft substitutes CERAMENT® BONE VOID FILLER (BVF), CERAMENT® G* and CERAMENT® V* are all based on the Company’s novel and proprietary CERAMENT technology platform. 

The Company’s products are targeting a large addressable market opportunity across trauma, chronic osteomyelitis (bone infection), revision arthroplasty (replacement of a joint prosthesis) and infected diabetic foot.

BONESUPPORT’s total sales increased from SEK 62 million in 2015 to SEK 129 million in 2017, representing a compound annual growth rate of 45%. The Company’s financial target is to achieve revenue exceeding SEK 500 million in the financial year 2020, with a gross margin exceeding 85 percent and a positive operating profit.

The Company’s research and development is focused on the continuing development and refinement of its CERAMENT technology to extend its use into additional indications by the elution of other drugs and therapeutic agents. The Company currently has a pipeline of pre-clinical product candidates that have been designed to promote bone growth.

BONESUPPORT is listed on Nasdaq Stockholm and trades under the ticker “BONEX” (ISIN code: SE0009858152). Further information is available at bonesupport.com

*CERAMENT G: Not available in the United States, for investigational use only. CERAMENT V: Not available in the United States

BONESUPPORT™ and CERAMENT® are registered trademarks.

 

For more information contact:

Björn Westberg, CFO

+46 (0) 46 286 53 60

ir@bonesupport.com

 

Citigate Dewe Rogerson

Pip Batty, David Dible, Shabnam Bashir, Isabelle Andrews

+44 (0)20 7282 1022

bonesupport@citigatedewerogerson.com

 

Downloads

Press release PDF (122.98 KB)

Change in number of shares and votes in BONESUPPORT HOLDING AB (publ)

28th February 2018

Change in number of shares and votes in BONESUPPORT HOLDING AB (publ)

Lund, Sweden, 18:00 CET 28 February 2018 - During February, the number of shares and votes in BONESUPPORT HOLDING AB (publ) has increased due to the exercise of warrants. As of
28 February 2018, the number of shares and votes in BONESUPPORT HOLDING AB (publ) amounts to 50,811,866.

 

About BONESUPPORTTM

BONESUPPORT is an innovative and rapidly growing commercial stage orthobiologics company, based in Lund, Sweden. The Company develops and commercializes innovative injectable bio-ceramic bone graft substitutes that remodel to the patient’s own bone and have the capability of eluting drugs directly into the bone void.

BONESUPPORT’s marketed bio-ceramic bone graft substitutes CERAMENT® BONE VOID FILLER (BVF), CERAMENT® G* and CERAMENT® V* are all based on the Company’s novel and proprietary CERAMENT technology platform.

 The Company’s products are targeting a large addressable market opportunity across trauma, chronic osteomyelitis (bone infection), revision arthroplasty (replacement of a joint prosthesis) and infected diabetic foot. BONESUPPORT’s total sales increased from SEK 62 million in 2015 to SEK 129 million in 2017,

representing a compound annual growth rate of 45 percent. The Company’s financial target is to achieve revenue exceeding SEK 500 million in the financial year 2020, with a gross margin exceeding 85 percent and a positive operating profit.

The Company’s research and development is focused on the continuing development and refinement of its CERAMENT technology to extend its use into additional indications by the elution of other drugs and therapeutic agents. The Company currently has a pipeline of pre-clinical product candidates that have been designed to promote bone growth.

BONESUPPORT is listed on Nasdaq Stockholm and trades under the ticker “BONEX” (ISIN code: SE0009858152). Further information is available at bonesupport.com

*CERAMENT G: Not available in the United States, for investigational use only. CERAMENT V: Not available in the United States

BONESUPPORT™ and CERAMENT® are registered trademarks.

For more information contact:

Richard Davies, CEO                                                                      

Tel: +46 (0) 46 286 53 70

 

Björn Westberg, CFO

Tel: +46 (0) 46 286 53 60

Email: ir@bonesupport.com

The information in the press release is such that BONESUPPORT HOLDING AB (publ) is required to disclose pursuant to the Swedish Financial Instruments Trading Act. The information was submitted for publication, through the agency of the contact persons set out above, at 18:00 CET on 28 February 2018.

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Press release PDF (114.91 KB)

BONESUPPORT™ HOLDING AB (Publ) – Q4 and 2017 Year-End Report – January – December

20th February 2018

BONESUPPORT™ HOLDING AB (Publ) – Q4 and 2017 Year-End Report – January – December

Lund, Sweden, 08.00 CET, 20 February 2018 – BONESUPPORTTM, an emerging leader in innovative injectable bio-ceramic bone substitute products to treat bone voids caused by trauma, infection, disease or related surgery based on its unique CERAMENT® platform today announces the publication of its Q4 and Year-End Report - January – December 2017.

2017 net sales increased by 24%

FINANCIAL HIGHLIGHTS

OCTOBER – DECEMBER 2017

Net Sales amounted to SEK 27.0 million (29.6), a decrease of 9%

Gross margin of 83.3% (87.8)

Operating loss of SEK ‐33.4 million (‐28.4) 

Earnings per share, before and after dilution was SEK ‐1.03 (‐1.24)

 

JANUARY – DECEMBER 2017

Net Sales amounted to SEK 129.3 million (104.6), an increase of 24%

Gross margin of 87.0% (84.4)

Operating loss of SEK ‐99.3 million (‐88.7)

Earnings per share, before and after dilution was SEK ‐3.24 (‐4.26)

 

BUSINESS HIGHLIGHTS

OCTOBER – DECEMBER 2017

CERTiFy study completed (136 patients) in this important level 1 trauma study comparing CERAMENT bone void filler with autograft.

BONESUPPORT signed distribution agreement for the Italian market with Citieffe Srl.

Ms Helena L Brandt appointed Head of Human Resources.

 

SIGNIFICANT EVENTS AFTER PERIOD END

BONESUPPORT announced 23 January the appointment of Emil Billbäck as CEO, effective as of 1 March.

BONESUPPORT repaid the outstanding debt of EUR 9.5 million to Kreos.

Richard Davies, CEO of BONESUPPORT, said: “In Europe and the rest of the world we delivered our best-ever quarterly sales performance in the region with sales increasing by 39% vs Q4 2016 to SEK 14.5 million. This was due to the continued success of our drug eluting products, CERAMENT G and CERAMENT V driven by surgeon preference.  The increasing level of clinical evidence supporting CERAMENT’s ability to remodel to host bone and to deliver antibiotics to protect bone healing is key to this choice.

We are also making good progress with our key clinical studies, CERTiFy has completed patient recruitment and results are expected later in 2018. Patient recruitment in the FORTIFY study, with CERAMENT G, is on track to support our goal of filing a PMA with FDA in 2020.

“Over the last 2 years we have positioned BONESUPPORT to become a leading player in orthobiologics. We have invested in our sales and marketing capabilities, and in the clinical data needed to drive the sales of our highly differentiated drug eluting products. We have also built a strong management team and raised the funds needed to execute our value enhancing strategy through to 2020.

“Given this progress, it is the right time for me to hand over the reins to Emil Billbäck, who will become BONESUPPORT’s new CEO on 1 March. I wish him every success and am confident that the Company will deliver significant shareholder value in the years to come based on its unique CERAMENT platform.”

 

The full Report is available by clicking on the links below:

Outside the US: https://bonesupport.com/en-eu/financial-reports-inv/

US: https://bonesupport.com/en-us/financial-reports-us/

 

The report will be available on BONESUPPORT’s website from 08:00 am CET the same day and the presentation from the webcast will be uploaded during the day on 20 February.

 

Conference Call/Webcast Details

The Company will host a conference call and an online presentation at 10.00am CET today.

The dial-in numbers for the conference call are:

UK: +442030089808

SE: +46850639549

US: +18557532235

 

Webcast

The presentation will also be webcast and can be accessed from the following web address: https://financialhearings.com/event/10530

Hosts: Richard Davies, CEO, and Björn Westberg, CFO

 

About BONESUPPORT™

BONESUPPORT is an innovative and rapidly growing commercial stage orthobiologics company, based in Lund, Sweden. The Company develops and commercializes innovative injectable bio-ceramic bone graft substitutes that remodel to the patient’s own bone and have the capability of eluting drugs directly into the bone void.

BONESUPPORT’s marketed bio-ceramic bone graft substitutes CERAMENT® BONE VOID FILLER (BVF), CERAMENT® G* and CERAMENT® V* are all based on the Company’s novel and proprietary CERAMENT technology platform.

The Company’s products are targeting a large addressable market opportunity across trauma, chronic osteomyelitis (bone infection), revision arthroplasty (replacement of a joint prosthesis) and infected diabetic foot.

BONESUPPORT’s total sales increased from SEK 62 million in 2015 to SEK 129 million in 2017, representing a compound annual growth rate of 45%. The Company’s financial target is to achieve revenue exceeding SEK 500 million in the financial year 2020, with a gross margin exceeding 85 percent and a positive operating profit.

The Company’s research and development is focused on the continuing development and refinement of its CERAMENT technology to extend its use into additional indications by the elution of other drugs and therapeutic agents. The Company currently has a pipeline of pre-clinical product candidates that have been designed to promote bone growth.

BONESUPPORT is listed on Nasdaq Stockholm and trades under the ticker “BONEX” (ISIN code: SE0009858152). Further information is available at bonesupport.com

*CERAMENT G: Not available in the United States, for investigational use only. CERAMENT V: Not available in the United States

BONESUPPORT™ and CERAMENT® are registered trademarks.

For more information contact:

Richard Davies, CEO

+46 (0) 46 286 53 71

 

Björn Westberg, CFO

+46 (0) 46 286 53 60

ir@bonesupport.com

 

Citigate Dewe Rogerson

Pip Batty, David Dible, Shabnam Bashir, Isabelle Andrews

+44 (0)20 7282 1022

bonesupport@citigatedewerogerson.com

 

PM som innehåller insiderinformation (ink. finansiell rapport annan än halvår och årsredovisning)

This information is such information as BONESUPPORT HOLDING AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 08.00am CET on 20th February 2018.

 

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BONESUPPORT HOLDING AB – Year-end Report January-December 2017 – invitation to conference call and webcast

6th February 2018

BONESUPPORT HOLDING AB – Year-end Report January-December 2017 – invitation to conference call and webcast

Lund, Sweden, 08.00 CET, 6 February 2018 – BONESUPPORTTM, an emerging leader in innovative injectable bio-ceramic bone substitute products to treat bone voids caused by trauma, infection, disease or related surgery based on its unique CERAMENT® platform, will publish its Year-end Report for January-December 2017 on Tuesday 20 February 2018 at 08.00am CET.

The Company will also host a conference call and an online presentation on the same day at 10am CET.

The dial-in numbers for the conference call are:

UK: +442030089808

SE: +46850639549

US: +18557532235

The presentation will also be webcast and can be accessed from the following web address:

https://financialhearings.com/event/10530

Hosts: BONESUPPORT AB Management

Notes to Editor

About BONESUPPORT™

BONESUPPORT is an innovative and rapidly growing commercial stage orthobiologics company, based in Lund, Sweden. The Company develops and commercializes innovative injectable bio-ceramic bone graft substitutes that remodel to the patient’s own bone and have the capability of eluting drugs directly into the bone void.

BONESUPPORT’s marketed bio-ceramic bone graft substitutes CERAMENT® BONE VOID FILLER (BVF), CERAMENT® G* and CERAMENT® V* are all based on the Company’s novel and proprietary CERAMENT technology platform.

The Company’s products are targeting a large addressable market opportunity across trauma, chronic osteomyelitis (bone infection), revision arthroplasty (replacement of a joint prosthesis) and infected diabetic foot.

BONESUPPORT’s total sales increased from SEK 41 million in 2014 to SEK 105 million in 2016, representing a compound annual growth rate of 60 percent. The Company’s financial target is to achieve revenue exceeding SEK 500 million in the financial year 2020, with a gross margin exceeding 85 percent and a positive operating profit.

The Company’s research and development is focused on the continuing development and refinement of its CERAMENT technology to extend its use into additional indications by the elution of other drugs and therapeutic agents. The Company currently has a pipeline of pre-clinical product candidates that have been designed to promote bone growth.

BONESUPPORT is listed on Nasdaq Stockholm and trades under the ticker “BONEX” (ISIN code: SE0009858152). Further information is available at bonesupport.com

*CERAMENT G: Not available in the United States, for investigational use only.  CERAMENT V: Not available in the United States

BONESUPPORT™ and CERAMENT® are registered trademarks.

Contact Information

BONESUPPORT AB

Richard Davies, CEO

+46 (0) 46 286 53 71

 

Björn Westberg, CFO

+46 (0) 46 286 53 60

ir@bonesupport.com

 

Citigate Dewe Rogerson

Pip Batty, David Dible, Shabnam Bashir

+44 (0)20 7282 1022

bonesupport@citigatedewerogerson.com

Downloads

Press release PDF (121.74 KB)

BONESUPPORT™ repays outstanding loan from Kreos

1st February 2018

BONESUPPORT™ repays outstanding loan from Kreos

Lund, Sweden, 18:00 CET 1 February 2018BONESUPPORT HOLDING AB’s subsidiary BONESUPPORT AB has repaid the remaining debt under the loan facility from Kreos Capital V (UK) Ltd. The original loan agreement, which was signed in September 2016 included two tranches, one of EUR 13.4 million and one of EUR 8.9 million. BONESUPPORT has only drawn down the first tranche of EUR 13.4 million, which was disbursed to BONESUPPORT on 30 September 2016. The outstanding amount of the first tranche at the end of January 2018 was EUR 9.5 million, which was repaid today. In addition, the Company paid an early termination fee of EUR 0.7 million plus costs for legal counsel.

Björn Westberg, CFO of BONESUPPORT, commented: “Given our strong financial position and the high interest expense associated with this loan facility, we believe that the decision to repay it early is the right thing to do from a financial perspective.”

 

About BONESUPPORTTM

BONESUPPORT is an innovative and rapidly growing commercial stage orthobiologics company, based in Lund, Sweden. The Company develops and commercializes innovative injectable bio-ceramic bone graft substitutes that remodel to the patient’s own bone and have the capability of eluting drugs directly into the bone void. BONESUPPORT’s marketed bio-ceramic bone graft substitutes CERAMENT® BONE VOID FILLER (BVF), CERAMENT® G* and CERAMENT® V* are all based on the Company’s novel and proprietary CERAMENT technology platform.

The Company’s products are targeting a large addressable market opportunity across trauma, chronic osteomyelitis (bone infection), revision arthroplasty (replacement of a joint prosthesis) and infected diabetic foot.

BONESUPPORT’s total sales increased from SEK 41 million in 2014 to SEK 105 million in 2016, representing a compound annual growth rate of 60 percent. The Company’s financial target is to achieve revenue exceeding SEK 500 million in the financial year 2020, with a gross margin exceeding 85 percent and a positive operating profit.

The Company’s research and development is focused on the continuing development and refinement of its CERAMENT technology to extend its use into additional indications by the elution of other drugs and therapeutic agents. The Company currently has a pipeline of pre-clinical product candidates that have been designed to promote bone growth.

BONESUPPORT is listed on Nasdaq Stockholm and trades under the ticker “BONEX” (ISIN code: SE0009858152). Further information is available at bonesupport.com

*CERAMENT G: Not available in the United States, for investigational use only. CERAMENT V: Not available in the United States.

BONESUPPORT™ and CERAMENT® are registered trademarks.

For more information contact:

Björn Westberg, CFO

Tel: +46 (0) 46 286 53 60

Email: ir@bonesupport.com

The information was submitted for publication at 18:00 CET on 1 February 2018.

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Change in number of shares and votes in BONESUPPORT HOLDING AB (publ)

31st January 2018

Change in number of shares and votes in BONESUPPORT HOLDING AB (publ)

Lund, Sweden, 18:00 CET 31 January 2018 - During January, the number of shares and votes in BONESUPPORT HOLDING AB (publ) has increased due to the exercise of warrants. As of
31 January 2018, the number of shares and votes in BONESUPPORT HOLDING AB (publ) amounts to 50,368,766.

 

About BONESUPPORTTM

BONESUPPORT is an innovative and rapidly growing commercial stage orthobiologics company, based in Lund, Sweden. The Company develops and commercializes innovative injectable bio-ceramic bone graft substitutes that remodel to the patient’s own bone and have the capability of eluting drugs directly into the bone void. BONESUPPORT’s marketed bio-ceramic bone graft substitutes CERAMENT® BONE VOID FILLER (BVF), CERAMENT® G* and CERAMENT® V* are all based on the Company’s novel and proprietary CERAMENT technology platform.

The Company’s products are targeting a large addressable market opportunity across trauma, chronic osteomyelitis (bone infection), revision arthroplasty (replacement of a joint prosthesis) and infected diabetic foot.

BONESUPPORT’s total sales increased from SEK 41 million in 2014 to SEK 105 million in 2016, representing a compound annual growth rate of 60 percent. The Company’s financial target is to achieve revenue exceeding SEK 500 million in the financial year 2020, with a gross margin exceeding 85 percent and a positive operating profit.

The Company’s research and development is focused on the continuing development and refinement of its CERAMENT technology to extend its use into additional indications by the elution of other drugs and therapeutic agents. The Company currently has a pipeline of pre-clinical product candidates that have been designed to promote bone growth.

BONESUPPORT is listed on Nasdaq Stockholm and trades under the ticker “BONEX” (ISIN code: SE0009858152). Further information is available at bonesupport.com

*CERAMENT G: Not available in the United States, for investigational use only. CERAMENT V: Not available in the United States.

BONESUPPORT™ and CERAMENT® are registered trademarks.

For more information contact:

Richard Davies, CEO                                                                      

Tel: +46 (0) 46 286 53 71

 

Björn Westberg, CFO

Tel: +46 (0) 46 286 53 60

Email: ir@bonesupport.com

The information in the press release is such that BONESUPPORT HOLDING AB (publ) is required to disclose pursuant to the Swedish Financial Instruments Trading Act. The information was submitted for publication, through the agency of the contact persons set out above, at 18:00 CET on 31 January 2018.

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Emil Billbäck appointed CEO of BONESUPPORT

23rd January 2018

Emil Billbäck appointed CEO of BONESUPPORT

Lund, Sweden 08.30 CET, 23 January 2018 – BONESUPPORT (Nasdaq Stockholm: BONEX), an emerging leader in innovative injectable bio-ceramic bone substitute products to treat bone voids caused by trauma, infection, disease or related surgery based on its unique CERAMENT® platform, announces that the Board of Directors has appointed Emil Billbäck as the new CEO of BONESUPPORT HOLDING AB. Mr. Billbäck has over 20 years management experience from the life science industry and the Board of Directors is of the opinion that he has the ideal profile to implement the Company’s strategy and to deliver shareholder value. He will join BONESUPPPORT on 1st March 2018 when he will replace Richard Davies who has been the Company’s CEO since January 2016.

Mr. Billbäck, who lives in Malmö and is a Swedish citizen, will join from Essity where he was Senior Advisor following its acquisition of BSN Medical from the Swedish private equity group EQT in 2017. Prior to this, he was a member of the Group Executive Board/Management Committee at BSN Medical, where he held the position of Executive Vice President EMEA and Head of Global Commercial Operations. Mr. Billbäck spent over 13 years in senior management roles at BSN Medical, including Interim President of North America and Group Director Commercial Operations and R&D. BSN Medical develops, manufactures, markets and sells products within wound care, compression therapy and orthopedics.

Håkan Björklund, Chairman of BONESUPPORT, commenting on today’s announcement said: “I would like to thank Richard Davies for the significant contributions he has made to the company which have included an impressive growth of the business as well putting the company in a strong financial position following its IPO on Nasdaq Stockholm in June 2017.  As the company is becoming much bigger and more complex, it will benefit from a full time leadership presence at the headquarters in Lund. I am very pleased that we have attracted someone of Emil’s caliber to become the CEO of BONESUPPORT. He has extensive experience in areas of the healthcare market which are central to BONESUPPORT’s future success and will provide excellent leadership under which BONESUPPORT can continue to realize its significant potential.”

Emil Billbäck, commenting on his appointment said: “I am looking forward to becoming the CEO of BONESUPPORT. It is clear that the Company has an exciting future based on the significant growth potential of its current commercial products for the management of bone voids. These products, which are based on the Company’s highly differentiated CERAMENT platform, deliver important clinical and economic benefits to surgeons, patients and payers based on their ability to remodel to host bone and to elute antibiotics to protect the healing process by preventing infection. I also believe that BONESUPPORT’s pipeline, which is focused on novel products designed to enhance bone growth, will contribute to the Company’s longer term success.”

Richard Davies commented: “I am very proud of what we have built over the last two years and I am confident that success will endure going forward. I would like to thank my colleagues for their contributions and fellowship and I wish Emil the best of success for the future.”

 

About BONESUPPORT™

BONESUPPORT is an innovative and rapidly growing commercial stage orthobiologics company, based in Lund, Sweden. The Company develops and commercializes innovative injectable bio-ceramic bone graft substitutes that remodel to the patient’s own bone and have the capability of eluting drugs directly into the bone void.

BONESUPPORT’s marketed bio-ceramic bone graft substitutes CERAMENT® BONE VOID FILLER (BVF), CERAMENT® G* and CERAMENT® V* are all based on the Company’s novel and proprietary CERAMENT technology platform.

The Company’s products are targeting a large addressable market opportunity across trauma, chronic osteomyelitis (bone infection), revision arthroplasty (replacement of a joint prosthesis) and infected diabetic foot.

BONESUPPORT’s total sales increased from SEK 41 million in 2014 to SEK 105 million in 2016, representing a compound annual growth rate of 60 percent. The Company’s financial target is to achieve revenue exceeding SEK 500 million in the financial year 2020, with a gross margin exceeding 85 percent and a positive operating profit.

The Company’s research and development is focused on the continuing development and refinement of its CERAMENT technology to extend its use into additional indications by the elution of other drugs and therapeutic agents. The Company currently has a pipeline of pre-clinical product candidates that have been designed to promote bone growth.

BONESUPPORT is listed on Nasdaq Stockholm and trades under the ticker “BONEX” (ISIN code: SE0009858152). Further information is available at bonesupport.com

*CERAMENT G: Not available in the United States, for investigational use only. CERAMENT V: Not available in the United States

BONESUPPORT™ and CERAMENT® are registered trademarks.

For more information contact:

Håkan Björklund, Chairman of the Board of Directors

+45 (0) 40 88 85 00

 

Citigate Dewe Rogerson

David Dible

+44 (0)20 7282 2949

bonesupport@citigatedewerogerson.com

 

This information is such information as BONESUPPORT HOLDING AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 08:30 CET on 23 January 2018.

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PUBLICATION HIGHLIGHTS A NOVEL CERAMENT® CARRIER WITH BONE ACTIVE AGENTS ENHANCING BONE FORMATION

22nd January 2018

PUBLICATION HIGHLIGHTS A NOVEL CERAMENT® CARRIER WITH BONE ACTIVE AGENTS ENHANCING BONE FORMATION

Lund, Sweden, 08.00 CET, 22 January 2018 – BONESUPPORTTM, an emerging leader in innovative injectable bio-ceramic bone substitute products to treat bone voids caused by trauma, infection, disease or related surgery based on its unique platform  announces that a paper “Gelatin- hydroxyapatite-calcium sulphate based biomaterial for long term sustained delivery of bone morphogenic protein-2 and zoledronic acid for increased bone formation: In-vitro and in-vivo carrier properties, - D Raina et al 2018- has been published online in the Journal of Controlled Release.

The paper* can be viewed here: https://authors.elsevier.com/a/1WPE7cI2~mAUJ

The publication shows that a novel macro-porous biomaterial, Gelatin/CERAMENT, is an efficient carrier for the long-term, sustained delivery of recombinant bone morphogenic protein (rhBMP-2) and zoledronic acid (ZA) leading to increased bone formation in a pre-clinical animal model when compared to commercially available carrier for rhBMP-2.

BONESUPPORT has acquired the IP to the novel Gelatin/CERAMENT biomaterial from Seagles AB, a company owned by Lars Lidgren, who is one of the members of the Swedish/Indian research group that developed the new material and the founder of BONESUPPORT. A first patent application covering a macro porous biopolymer ceramic biomaterial as a carrier for bone active agents was submitted to the European Patent Office in September 2017.

Mr Deepak Raina, Department of Orthopedics, Medical Faculty, Lund University, Sweden, and lead author of the publication, said: “In this study, we produced and characterized a novel macroporous gelatin/CERAMENT-based cryogel scaffold for the delivery of rhBMP-2 and ZA. In-vivo experiments showed that the scaffold enabled increased bone formation compared to a currently approved carrier with BMP. We believe that it is a crucial step in the development of biomaterials that are needed to facilitate the co-delivery of rhBMP-2 and ZA, to enhance bone growth in demanding clinical situations where bone regeneration is essential but difficult to achieve.”

Dr Jerry Chang, Executive Vice President and Head of Research and Development at BONESUPPORT, said: "The Journal of Controlled Release publication clearly shows the potential of a novel CERAMENT-based biomaterial as a carrier of bioactives designed to enhance bone growth. We believe the acquisition of this technology is an important addition to our product pipeline which is focused on meeting the growing clinical need for novel osteoinductive synthetic bone graft substitutes for a broad range of orthopedic indications and, in particular in the spine.”

*Link valid until 8th March 2018

 

About BONESUPPORT™

BONESUPPORT is an innovative and rapidly growing commercial stage orthobiologics company, based in Lund, Sweden. The Company develops and commercializes innovative injectable bio-ceramic bone graft substitutes that remodel to the patient’s own bone and have the capability of eluting drugs directly into the bone void.

BONESUPPORT’s marketed bio-ceramic bone graft substitutes CERAMENT® BONE VOID FILLER (BVF), CERAMENT® G* and CERAMENT® V* are all based on the Company’s novel and proprietary CERAMENT technology platform.

The Company’s products are targeting a large addressable market opportunity across trauma, chronic osteomyelitis (bone infection), revision arthroplasty (replacement of a joint prosthesis) and infected diabetic foot.

BONESUPPORT’s total sales increased from SEK 41 million in 2014 to SEK 105 million in 2016, representing a compound annual growth rate of 60 percent. The Company’s financial target is to achieve revenue exceeding SEK 500 million in the financial year 2020, with a gross margin exceeding 85 percent and a positive operating profit.

The Company’s research and development is focused on the continuing development and refinement of its CERAMENT technology to extend its use into additional indications by the elution of other drugs and therapeutic agents. The Company currently has a pipeline of pre-clinical product candidates that have been designed to promote bone growth.

BONESUPPORT is listed on Nasdaq Stockholm and trades under the ticker “BONEX” (ISIN code: SE0009858152). Further information is available at bonesupport.com

*CERAMENT G: Not available in the United States, for investigational use only.  CERAMENT V: Not available in the United States

BONESUPPORT™ and CERAMENT® are registered trademarks.

For more information contact:

Richard Davies, CEO

+46 (0) 46 286 53 71

 

Björn Westberg, CFO

+46 (0) 46 286 53 60

ir@bonesupport.com

 

Citigate Dewe Rogerson

Pip Batty, David Dible, Shabnam Bashir

+44 (0)20 7282 1022

bonesupport@citigatedewerogerson.com

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Press release PDF (126.63 KB)

Press releases

December 16, 2011

Lloyd Diamond new CEO of BONESUPPORT™ 

June 23, 2011

BONESUPPORT™ implements SEK 120 million ($19 mill; €13 mill) new share issue

May 19, 2011

BONESUPPORT™ raising in total 170 MSEK ($ 26 mill, € 18 mill)

 

Notes to Editor

 

About BONESUPPORT™

BONESUPPORT AB has developed CERAMENT™ as an innovative range of radiopaque injectable osteoconductive bioceramic products that have a proven ability to heal defects by remodeling to host bone in six to twelve months. Our products are effective in treating patients with fractures and bone voids caused by trauma, infection, disease or related surgery. Our lead product, CERAMENT™|BONE VOID FILLER (BVF) addresses important issues facing health care providers, such as avoiding hospital readmissions and revision surgery that result from failed bone healing and infection caused by residual bone voids. CERAMENT|BVF is commercially available in the U.S., EU, S.E. Asia and the Middle East.

CERAMENT's distinctive properties as a drug eluting material have been validated in clinical practice by CERAMENT™|G and CERAMENT™ V, the first CE-marked injectable antibiotic eluting bone graft substitutes. These products provide local sustained delivery of gentamicin and vancomycin, respectively. The local delivery feature enables an initial high concentration of antibiotics to the bone defect and then a longer sustainable dose above the minimal inhibitory concentration (MIC) to protect bone healing and promote bone remodeling.

CERAMENT|G and CERAMENT™ have demonstrated good results in patients with problematic bone infections including osteomyelitis. They are also used prophylactically in patients who are at risk for developing infection. CERAMENT|G and CERAMENT™ V are available in the EU.

BONESUPPORT AB was founded in 1999 by Prof. Lars Lidgren, an internationally respected scientist who has been the President of various musculoskeletal societies. BONESUPPORT’s mission is to bring people with bone and joint diseases back to an active life. The company is based in Lund, Sweden.

bonesupport.com

BONESUPPORT™ is a registered trademark.

Contact Information

Citigate Dewe Rogerson

David Dible, Andrea Bici, Mark Swallow

+44 (0)20 7282 2949/1050/2948

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Press release PDF (105.19 KB)

BONESUPPORT, Fri Mar 16, 2018

Martin McNally presented at @LimbRecon yesterday. BONESUPPORT is exhibiting this week, so please stop by for a hot… https://t.co/v1CslQ6sW5

BONESUPPORT, Fri Mar 9, 2018

A busy second day at @ORSsociety - the key US orthopaedic surgeon meeting - in New Orleans for BONESUPPORT https://t.co/H8JwPda7nw