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PRESS RELEASES


Björn Westberg to join BONESUPPORT™ as Chief Financial Officer

21st December

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

16th December

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

13th December

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

7th November

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

1st September

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™ Receives FDA Approval to Initiate IDE Clinical Study

9th August

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

1st March

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

2nd February

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

22nd January

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

11th January

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

7th January

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

5th January

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

29th December 2017

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

13th December 2017

BONESUPPORTTM OPENS ITS NEW HEAD QUARTERS

12th December 2017

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

30th November 2017

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

22nd November 2017

BONESUPPORTTM SIGNS COMMERCIALIZATION AGREEMENT FOR THE ITALIAN MARKET

20th November 2017

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

14th November 2017

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

2nd November 2017

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

31st October 2017

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

19th October 2017

BONESUPPORTTM APPOINTS HELENA L BRANDT AS HEAD OF HUMAN RESOURCES

13th October 2017

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

9th October 2017

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

29th September 2017

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

20th September 2017

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

19th September 2017

BONESUPPORT™ SIGNS COMMERCIALIZATION AGREEMENT FOR THE FRENCH MARKET

7th September 2017

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

31st August 2017

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

17th August 2017

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

11th August 2017

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

31st July 2017

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

21st July 2017

Stabilization notice

17th July 2017

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

12th July 2017

Stabilization notice

5th July 2017

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

30th June 2017

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

21st June 2017

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

22nd May

Lennart Johansson to join BONESUPPORT™ Board of Directors

28th April

BONESUPPORT™ appoints Michael Diefenbeck as Chief Medical Officer

11th April

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

16th March

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

14th March

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

6th January

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

28th December 2018

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

30th November 2018

BONESUPPORT - POSITIVE RESULTS FROM THE CERTiFy STUDY COMPARING CERAMENT®|BONE VOID FILLER WITH AUTOGRAFT

19th November 2018

BONESUPPORT HOLDING AB (publ) – Interim Report

7th November 2018

BONESUPPORT HOLDING AB (publ) – Q3 2018 Interim Report – invitation to conference call and webcast

1st November 2018

BONESUPPORT starts selling CERAMENT® BONE VOID FILLER Direct in the US via its own New Distributor Network

22nd October 2018

BONESUPPORT to Showcase CERAMENT® BONE VOID FILLER at Two Upcoming US Orthopedic Conferences

8th October 2018

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

28th September 2018

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

19th September 2018

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

6th September 2018

Invitation BONESUPPORT Capital Markets Days

5th September 2018

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

24th August 2018

BONESUPPORT - CERAMENT® G Approved by Health Canada

16th August 2018

BONESUPPORT Signs Agreement with MTF Biologics to Expand US Product Offering

2nd August 2018

BONESUPPORT HOLDING AB (publ) – Interim Report

26th July 2018

Q2 2018 Interim Report – invitation to conference call and webcast

23rd July 2018

BONESUPPORT appoints Michael Diefenbeck as Head of Research & Development, Medical and Clinical Affairs

18th July 2018

Håkan Johansson to start as BONESUPPORT’s CFO at the end of 2018

4th July 2018

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

29th June 2018

BONESUPPORT provides update on US orders of CERAMENT BVF

21st June 2018

BONESUPPORT to significantly expand its European sales organization

29th May 2018

BONESUPPORT Signs Strategic Agreement with Collagen Matrix, Inc. to Expand Product Offering in the US

24th May 2018

BULLETIN FROM THE ANNUAL SHAREHOLDERS’ MEETING IN BONESUPPORT HOLDING AB ON 22 MAY 2018

22nd May 2018

BONESUPPORT creates its own US Commercial Platform

17th May 2018

BONESUPPORT HOLDING AB (Publ) – Q1 Interim Report

4th May 2018

BONESUPPORT HOLDING AB (publ) publishes Annual Report 2017

30th April 2018

BONESUPPORT HOLDING AB (publ) – Q1 2018 Interim Report – invitation to conference call and webcast

27th April 2018

NOTICE OF ANNUAL SHAREHOLDERS’ MEETING IN BONESUPPORT HOLDING AB

20th April 2018

BONESUPPORT™ – Positive clinical data for CERAMENT® G in infection management presented at BLRS 2018

21st March 2018

BONESUPPORT’s New CEO Purchases Shares

13th March 2018

BONESUPPORTTM to present at Orthopaedic Research Society (ORS) 2018 Annual Meeting

9th March 2018

BONESUPPORT™ to present at Canaccord Musculoskeletal Conference

5th March 2018

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

28th February 2018

BONESUPPORT™ HOLDING AB (Publ) – Q4 and 2017 Year-End Report – January – December

20th February 2018

BONESUPPORT HOLDING AB – Year-end Report January-December 2017 – invitation to conference call and webcast

6th February 2018

BONESUPPORT™ repays outstanding loan from Kreos

1st February 2018

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

31st January 2018

Emil Billbäck appointed CEO of BONESUPPORT

23rd January 2018

PUBLICATION HIGHLIGHTS A NOVEL CERAMENT® CARRIER WITH BONE ACTIVE AGENTS ENHANCING BONE FORMATION

22nd January 2018

BONESUPPORT HOLDING AB (publ) announces that the patient enrolment schedule for the ongoing FORTIFY study is extended

21 August 2019

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

31 July 2019

BONESUPPORT HOLDING AB (publ) – Publishes Q2 2019 Interim report

25 July 2019

Item affecting comparability in Q2 2019

19 July 2019

BONESUPPORT HOLDING AB (publ) – Q2 2019 Interim Report – invitation to conference call and webcast

18 July 2019

BULLETIN FROM THE ANNUAL SHAREHOLDERS’ MEETING IN BONESUPPORT HOLDING AB ON 14 MAY 2019

14th May 2019

BONESUPPORT HOLDING AB (publ) – Published Q1 2019 Interim report

2nd May 2019

BONESUPPORT HOLDING AB (publ) – Q1 2019 Interim Report – invitation to conference call and webcast

25th April 2019

BONESUPPORT - Change in the management team

24th April 2019

BONESUPPORT HOLDING AB (publ) publishes Annual Report 2018

17th April 2019

BONESUPPORT will publish quarterly report earlier than previously communicated

16th April 2019

NOTICE OF ANNUAL SHAREHOLDERS’ MEETING IN BONESUPPORT HOLDING AB

12th April 2019

ACTIVE REMODELING OF CERAMENT® INTO HUMAN BONE CONFIRMED IN UK STUDY

10th April 2019

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

29th March 2019

BONESUPPORT LAUNCHING A NEW PRODUCT - BONIFY - US PRODUCT PORTFOLIO EXPANSION

13th March 2019

Issue and repurchase of series C shares for share saving programs

1st March 2019

BONESUPPORT HOLDING AB (publ) – Full Year Report 2018

27th February 2019

BONESUPPORT – Publication of a clinical study highlighting Vancomycin release from CERAMENT® V in major hip surgery

22nd February 2019

BONESUPPORT HOLDING AB (publ) – Invitation to conference call in connection of the Full Year Report 2018

20th February 2019

Correction of error Q3 (18) report

13th February 2019

BONESUPPORT – Publication of pre-clinical study highlighting unique bone remodeling qualities of CERAMENT® in large bone defects

8th February 2019

BONESUPPORTTM and Lund University to present at Orthopaedic Research Society (ORS) 2019 Annual Meeting

1st February 2019

BONESUPPORT appoints Annelie Aava Vikner as Executive Vice President Global Marketing & Communications

4th January 2019

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

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

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

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

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

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

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

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

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

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

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

Ends

Notes to Editor

About BONESUPPORT™

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

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

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

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

bonesupport.com

BONESUPPORT™ and CERAMENT are registered trademarks.

Contact Information

BONESUPPORT AB

Richard Davies

info@bonesupport.com

+46 (0)46 286 53 24

 

Citigate Dewe Rogerson

David Dible, Mark Swallow, Marine Perrier

bonesupport@citigatedr.co.uk

+44 (0)20 7638 9571

Downloads

Press release PDF (122.29 KB)

BONESUPPORT, Fri Aug 2, 2019

@MSIS 2019 CERAMENT Bone Void Filler injectable bone graft substitute remodels to bone 6-12 months. Meet… https://t.co/vbLgu854rt

BONESUPPORT, Fri Aug 2, 2019

@BONESUPPORT_AB is exhibiting at the MSIS congress NYC. Hear more about CERAMENT G resorbable injectable antibiotic… https://t.co/JJ8wURMyNT

BONESUPPORT, Thu Mar 21, 2019

Busy first day at @OBIC! Come a meet BONESUPPORT tomorrow and learn more about CERAMENT G and V. https://t.co/Ulc3BGPgIF