Exton, Pennsylvania-based DSM Biomedical has announced a new partnership with Cerapedics, Inc. to develop and manufacture a new peptide enhanced bone graft.
DSM, Cerapedics Partner to Develop Peptide Enhanced Graft
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Cerapedic’s i-FACTOR Peptide Enhanced Bone Graft, which is based on the biological activity of the synthetically derived 15-amino acid peptide found naturally in type I human collagen, was the winner of the Best Spine Technology of 2016 award from Orthopedics This Week.
i-FACTOR’s 15-amino acid peptide (P-15) is responsible for the attachment and proliferation of osteogenic cells and it is the first and only bone graft technology FDA approved for cervical fusion
As DSM wrote in its October 12, 2017 news release, “DSM’s newest bioceramic platform is a carbonated apatite matrix designed for fast, predictable remodeling in bone graft substitute applications. Under the partnership agreement with Cerapedics, DSM will also provide a collagen carrier, final packaging, and full support from concept through commercialization.”
Cerapedics developed P-15 technology to support bone growth through cell attraction, attachment, and activation. The company’s first-generation product, i-FACTOR Peptide Enhanced Bone Graft, has been commercially available outside of the U.S. (OUS) since 2008, and in the U.S. for anterior cervical discectomy and fusion (ACDF) procedures since late 2015. Cerapedics is partnering with DSM to collaboratively develop and commercialize the next generation of this technology.
“The partnership combines the industry leading expertise and capabilities in bioceramic materials of DSM with Cerapedics’ innovative growth factor, delivering a new product solution to improve people’s lives,” said David Yonce, Vice President and Global Head of Innovation at DSM Biomedical. “Together, from concept to commercialization, we are at the leading edge of advanced healing solutions.”
Jeffrey G. Marx, Ph.D., president and chief operating officer, told OTW, “The collaboration between Cerapedics and DSM allows us to leverage the strengths of each organization to create a truly superior product that neither organization could have developed on their own. This program is an excellent example of creating leverage via partnership. We’re excited to add DSM’s world-class bio ceramics, collagen, and final device manufacturing capability for this next generation product as well.”
“We’ve made a lot of progress in the joint development program to date with some really exciting milestones coming up in the next year. We plan to file for a CE mark and subsequent additional OUS registrations in the next 12 months. Most impactful, for the longer term, is that we plan to file an IDE [investigational device exemption] to initiate a TLIF [transforaminal lumbar interbody fusion] study in the U.S. with the joint product.”
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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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