Lund, Sweden, 07:30 CET, 6 September 2018 – BONESUPPORT™, an emerging leader in orthobiologics for the management of bone voids, announces that abstracts detailing clinical research using the Company’s CERAMENT platform will feature prominently at the 37th Meeting of the European Bone & Joint Infection Society (EBJIS), which this year takes place on 6th September in Helsinki, Finland. EBJIS is the key European congress for physicians and surgeons managing patients with bone infections.
The EBJIS annual meeting will feature 11 abstracts highlighting research and clinical findings with CERAMENT® G and CERAMENT® V in indications such as trauma, chronic osteomyelitis and diabetic foot.
BONESUPPORT is a Platinum Sponsor of the event and will host a company-sponsored symposium with presentations from Oxford University Hospitals (Martin McNally and Jamie Ferguson) and University Hospitals Leuven (Willem-Jan Metsemakers).
Emil Billbäck, CEO of BONESUPPORT, said: “The research and clinical data to be presented highlights the increasing interest and use of CERAMENT G and V based on the unrivalled benefits they deliver to patients and orthopedic surgeons. It is an exciting time for BONESUPPORT with CERAMENT G recently having been approved for use by Health Canada.”
CERAMENT G and CERAMENT V are the only CE-marked injectable antibiotic eluting bone graft substitutes which provide local sustained delivery of gentamicin and vancomycin, respectively.
Both CERAMENT G and CERAMENT V are able to deliver an initial high concentration of antibiotic to the bone defect and then a longer sustainable dose above the minimal inhibitory concentration (MIC) to promote and protect bone healing and remodeling.
The Company is currently conducting the FORTIFY clinical trial to assess CERAMENT G’s ability to improve on the standard-of-care management of patients with open tibia fractures. The primary endpoints of the trial include the absence of deep infection at the fracture site and the lack of secondary procedures intended to promote fracture union. The trial will also evaluate the safety of CERAMENT G. The trial will enroll up to 230 patients at up to 30 centers in the US and Europe.
Positive data from the FORTIFY trial will be used to support BONESUPPORT’s PMA (Premarket Approval) filing for CERAMENT G in the US, where the product is expected to be launched in 2021.
BONESUPPORT is an innovative and rapidly growing commercial stage orthobiologics company, based in Lund, Sweden. The Company develops and commercializes innovative injectable bio-ceramic bone graft substitutes that remodel to the patient’s own bone and have the capability of eluting drugs directly into the bone void.
BONESUPPORT’s bio-ceramic bone graft substitutes CERAMENT® BONE VOID FILLER (BVF), CERAMENT® G* and CERAMENT® V* are all based on the Company’s novel and proprietary technology platform.
The Company’s products are targeting a large addressable market opportunity across trauma, chronic osteomyelitis (bone infection), revision arthroplasty (replacement of a joint prosthesis), ortho-oncology, foot and ankle, and infected diabetic foot.
BONESUPPORT’s total sales increased from SEK 62 million in 2015 to SEK 129 million in 2017, representing a compound annual growth rate of 45%.
The Company’s research and development is focused on the continuing development and refinement of its CERAMENT technology to extend its use into additional indications by the elution of drugs and therapeutic agents. The Company currently has a pipeline of pre-clinical product candidates that have been designed to promote bone growth.
In addition, BONESUPPORT is looking at opportunities to expand its product offering in the US and has entered into a strategic agreement with MTF Biologics and Collagen Matrix Inc. to market and distribute products that are complementary to CERAMENT BVF.
BONESUPPORT is listed on Nasdaq Stockholm and trades under the ticker “BONEX” (ISIN code: SE0009858152). Further information is available at www.bonesupport.com
*CERAMENT G: Not available in the United States, for investigational use only.
CERAMENT V: Not available in the United States.
BONESUPPORT™ and CERAMENT® are registered trademarks.
For more information contact:
Emil Billbäck, CEO
+46 (0) 46 286 53 70
Björn Westberg, CFO
+46 (0) 46 286 53 60
Citigate Dewe Rogerson
Pip Batty, David Dible, Shabnam Bashir
+44 (0)20 7282 1022
This information is such information as BONESUPPORT HOLDING AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 07.30 CET on 6 September 2018.