Menu

PRESS RELEASES


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 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:

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 (445.27 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://www.bonesupport.com/en-eu/financial-reports-inv/

US: https://www.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 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:

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 (415.1 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 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:

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 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.

 

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 (306.9 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 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:

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 (355.9 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 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:

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 (293.46 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 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:

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 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 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:

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 (481.23 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 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:

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 (470.61 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 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:

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.

Downloads

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://www.bonesupport.com/en-eu/financial-reports-inv/ 

US:https://www.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 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.

 

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 (428.59 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 www.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 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 www.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.

 

Downloads

Press release PDF (119.29 KB)

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 www.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

 

 

Downloads

Press release PDF (142.97 KB)

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.

 

Downloads

Press release PDF (90.76 KB)

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.

www.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

Downloads

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.

www.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 (140.06 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.

www.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 (107.82 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 (119.25 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 (107.84 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™

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

Downloads

Press release PDF (108.83 KB)

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

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

Downloads

Press release PDF (105.19 KB)

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)

BONESUPPORT, Mon Aug 7, 2017

BONESUPPORT is a #medtech company dedicated to development of injectable osteoconductive biomaterials https://t.co/SZVyGV3pkq

BONESUPPORT, Fri Aug 4, 2017

BONESUPPORT is a Scandinavian #medtech company dedicated to development of injectable osteoconductive biomaterials, https://t.co/SZVyGULOsS

BONESUPPORT, Tue Jul 4, 2017

BONESUPPORT is a Scandinavian #medtech company dedicated to development of injectable osteoconductive biomaterials, https://t.co/SZVyGULOsS