A Novel Method for Reduction of Bioburden in Bone Allografts - Phase II

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DESCRIPTION (provided by applicant): The direct result of phase I funding has been the development of a viable bone allograft terminal sterilization technology that will, for the first time, allow tissue banks to easily process bone tissue to a sterility assurance level equal to that called for in medical devices (SAL10-6). Biomechanical testing of sterilized born revealed that our supercritical CO2 process maintains all of the essential characteristics of the allograft. This is the first demonstration of a technology that can achieve this level of sterility while maintaining the overall strength of the graft as rigorously tested by 3 point bending. The development of this technology will facilitate continued innovation in orthopedic technologies that are currently limited by a lack of viable sterilization options. Indeed continued innovation will be required to meet the needs of the over 36 million Americans with musculoskeletal conditions that limit their ability to function, with cost to society of over 100 billion dollars annually. Supercritical CO2 sterilization will be an enabling technology by offering a sterilization alternative that is more compatible with biological molecules and cutting edge polymers. This sterilization technology will result in a wider diversity of orthopedic technologies that are both more functional and safer. Phase II funding will address the two questions that remain before the successful commercialization of the process for use in tissue banks. First is the comprehensive testing of the impact of our process on the ability of bone allografts to generate osteoinductive responses. Second, is the ability of the process to achieve viral inactivation? With these two questions answered the way will be cleared to immediately provide for safer allografts than current technology allows for, potentially impacting the lives of millions of allograft recipients.