Lund, Sweden, 08.00 CET, 13 December 2017 – BONESUPPORTTM, an emerging leader in innovative injectable bio-ceramic bone substitute products to treat bone voids caused by trauma, infection, disease or related surgery based on its unique CERAMENT® platform today announces that it has achieved its aim of recruiting 136 patients into the CERTiFy (CERAMENT® Treatment of Fracture defects) study.
CERTiFy is a prospective, randomized, controlled clinical study designed to compare the differences in pain, quality of life, and cost of care in the treatment of tibia plateau fracture-associated bone defects using either CERAMENT®|BONE VOID FILLER (CERAMENT BVF) or autologous bone grafting (autograft). Autograft is the current gold standard for bone graft procedure for the management of tibia plateau fractures.
The primary outcome of the study is based on data from the SF-12 Physical Component Summary, which assesses the patient’s physical functioning, at week 26. The co-primary endpoint is the pain level 26 weeks after surgery measured by a visual analog scale. The SF-12 Mental Component Summary after 26 weeks and the costs of care will serve as key secondary endpoints.
Initial top-line data from the study is expected towards the end of 2018. A publication providing more complete data from the CERTiFy study is expected in Q1 2019.
The CERTiFy study recruited patients from 20 top orthopedic trauma centers in Germany. Professor Pol. M. Rommens, Head of The Department of Orthopaedics and Traumatology at The University Medical Centre Mainz is the study’s Principle Investigator.
Professor P.M. Rommens said: “Bone graft substitutes, such as CERAMENT BVF, are widely used for reconstruction of post-traumatic bone defects. However, their clinical significance in comparison to autograft, the gold-standard in reconstruction of larger bone defects, is still the subject to debate. With CERTiFy we aim to demonstrate that CERAMENT BVF is non-inferior to autograft across a range of clinical parameters. If achieved, this would be a major advance in the treatment of post-traumatic bone defects given the fact that not two but only one operative procedures are needed for filling up the defect. I am looking forward to reporting the initial results from the study.”
BONESUPPORT CEO Richard Davies said: “We are pleased to have achieved this important milestone in the CERTiFy study that demonstrates BONESUPPORT’s ability to run significant complex multi-centre studies and generate Level I data that has the potential to change the practice of medicine. We are confident that positive data from CERTiFy would lead to much greater uptake of all CERAMENT products across multiple trauma indications due to their ease of use and lower procedure costs.”
BONESUPPORT is an innovative and rapidly growing commercial stage orthobiologics company, based in Lund, Sweden. The Company develops and commercializes innovative injectable bio-ceramic bone graft substitutes that remodel to the patient’s own bone and have the capability of eluting drugs directly into the bone void.
BONESUPPORT’s marketed bio-ceramic bone graft substitutes CERAMENT® BONE VOID FILLER (BVF), CERAMENT® G* and CERAMENT® V* are all based on the Company’s novel and proprietary CERAMENT technology platform.
The Company’s products are targeting a large addressable market opportunity across trauma, chronic osteomyelitis (bone infection), revision arthroplasty (replacement of a joint prosthesis) and infected diabetic foot.
BONESUPPORT’s total sales increased from SEK 41 million in 2014 to SEK 105 million in 2016, representing a compound annual growth rate of 60 percent. The Company’s financial target is to achieve revenue exceeding SEK 500 million in the financial year 2020, with a gross margin exceeding 85 percent and a positive operating profit.
The Company’s research and development is focused on the continuing development and refinement of its CERAMENT technology to extend its use into additional indications by the elution of other drugs and therapeutic agents. The Company currently has a pipeline of pre-clinical product candidates that have been designed to promote bone growth.
BONESUPPORT is listed on Nasdaq Stockholm and trades under the ticker “BONEX” (ISIN code: SE0009858152). Further information is available at bonesupport.com
*CERAMENT G: Not available in the United States, for investigational use only. CERAMENT V: Not available in the United States
BONESUPPORT™ and CERAMENT® are registered trademarks.
For more information contact:
Richard Davies, CEO
+46 (0) 46 286 53 71
Björn Westberg, CFO
+46 (0) 46 286 53 60
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 08:00am CET on 13th December 2017.