BONESUPPORT AB has just raised $37 million in equity and debt finance, funds that will be used, among other things, to drive the sale of CERAMENT. The company is known for its injectable bioceramic bone scaffolds meant for the treatment of bone voids caused by trauma, infection, disease or related surgery. 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.
BONESUPPORT Raises $37 Million

According to the October 27, 2016 news release, “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.”
The new funds will be used for “driving the sales of CERAMENT BVF [bone void filler], 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 [premarket approval] filing in the U.S. for CERAMENT G; building the company’s product pipeline by capitalizing on the unique drug eluting properties of its injectable osteoconductive/osteoinductive bioceramic platform.”
Asked about short-term plans, Richard Davies, CEO of BONESUPPORT, told OTW, “Short term we are focused on recruiting the first patient into the FORTIFY IDE [investigational device exemption] study which is intended to provide the clinical data we need to gain FDA approval for CERAMENT G in the U.S. This trial will evaluate the safety and efficacy of CERAMENT G as part of surgical repair of open diaphyseal tibial fractures. CERAMENT G is seeing rapidly growing demand in the EU due to its the bone healing/ bone remodeling properties and its ability to deliver highly effective concentrations of the gentamicin above the minimum inhibitory concentration (MIC) of many of the bacteria that cause deep bone infections.”
“Following the appointment of Patrick O’Donnell [general manager and executive vice president of Commercial Products U.S.], we are also looking to increase the use of CERAMENT BVF in the U.S., where its proven ability to manage bone voids is an important competitive advantage in a healthcare system which is increasingly focused on value based clinical solutions.”

Discussion
This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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