Osiris Therapeutics, Inc. and Stryker Corporation have entered into an exclusive, worldwide partnership for the commercialization and development of Osiris’ viable bone matrix tissue form.
Stryker Gets Exclusive Rights to Osiris Bone Allograft
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Under the agreement announced on December 22, 2014, Stryker has exclusive rights to BIO4, a bone allograft that contains both viable cells and growth factors. According to the announcement, BIO4 “is a safe alternative to autografts that minimizes the potential for harvest site co-morbidities. BIO4 is composed of a structural extracellular matrix, osteogenic and angiogenic growth factors, endogenous mesenchymal stem cells and osteoblasts. It possesses osteoconductive, osteoinductive, osteogenic and angiogenic properties that are required for bone repair and regeneration.”
Osiris will be responsible for manufacturing, continued research and product improvements while Stryker will be responsible for the commercialization and marketing of the product. “To demonstrate the differentiating benefits and ensure the continued success and growth of this innovative product, both organizations will collaborate on the design and conduct of future clinical development programs.”
BIO4 was developed by Osiris, also the creator of the first cellular allograft, utilizing their proprietary Biosmart cryopreservation technology. “It is ready-to-use out of the package and has differentiated handling compared to other products currently on the market. Originally branded as OvationOS, Osiris’ viable bone matrix tissue form will now be marketed by Stryker under the brand name BIO4.”
Lode Debrabandere, Ph.D., the president and CEO of Osiris said Osiris “was the pioneer in the allograft bone graft market with the introduction of Osteocel in 2005. This partnership combines the strengths of Stryker, an industry leader in marketing orthopedic and spine products and of Osiris, the cellular regenerative medicine leader who developed this next generation viable bone matrix.” Osteocel is a registered trademark of NuVasive, Inc.
Osiris developed the world’s first approved stem cell drug, remestemcel-L for graft versus host disease. Other products include Grafix for acute and chronic wounds, Cartiform, a viable chondral allograft for cartilage repair.
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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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