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.
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.
Would this be good for DDD; where spinal bones are rubbing against the other? I am in Philadelphia and am interested in cellular repair for my spinal injuries instead of the traditional methods being suggested to me right now. How far away from testing are you? Are you doing clinical trials? I would love to be considered if 1 or 2 years away. I am herniated in 3 areas (cervical, lumbar and thorasic) and being laid up for 4 months in recovery is a huge factor in not wanting to get help for my pain. Thank you! Karen Murphy
BIO4, formerly known as OvationOS, is licensed and sold by Stryker. This product was recently developed by Osiris Therapeutics and is currently manufactured by Osiris. Osiris has recently partnered with Stryker giving them an exclusive distribution agreement.
OvationOS [BIO4] is regulated by the FDA under 21 CFR Part 1271 Human Cells, Tissues and Cellular and Tissue-based Products (HCT/Ps). Osiris Therapeutics, Inc. is registered with the FDA as a tissue establishment and accredited by the American Association of Tissue Banks (AATB).
Its essentially a new product and sales to doctors and surgeons may begin soon. Some limited sales may have already occurred. My guess is that this product will officially be launched within the next few weeks, perhaps in the February-March timeframe. Emphasis is on “my guess”.
I’m not a doctor and can’t advise you on any medical condition and I’m not employed by Stryker or Osiris.