Terminal Sterilization of Tendon Allografts Using Supercritical CO2- Phase II

Award Information
Department of Health and Human Services
Solitcitation Year:
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Award Year:
Phase II
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Small Business Information
Hubzone Owned:
Woman Owned:
Socially and Economically Disadvantaged:
Principal Investigator
 (607) 330-2772
Business Contact
Phone: (607) 330-2772
Email: rac1@novasterilis.com
Research Institution
DESCRIPTION (provided by applicant): Currently, most tissue banks use a two step process to sterilize soft tissue allografts. The initial step reduces the bioburden with the second step in sterilization resulting in "terminal sterilization". The direct result of Phase 1 funding has been the development of a terminal sterilization technology using supercritical CO2 and a proprietary additive that will allow tissue banks to easily process soft tissue allografts to a sterility assurance level equal to that called for in medical devices (SAL6) in a one step process. Sterilization was confirmed according to the standards in AMI/ISO 11737-1 and 2. The sterilization technology is capable of inactivating a wide variety of microorganisms at concentrations of greater than 106 colony forming units (CFUs) in a half cycle. Utilizing sterilization times as determined from D-value calculations according to the methods of Stumbo-Murphy-Cochran (terminal sterilization at 2.5 hours and overkill at 4 hours) we assessed the affect of our supercritical CO2 process on the biomechanical properties of bone-tendon-bone (BTB) patellar tendon allografts. Biomechanical data obtained revealed no significant difference between the supercritical CO2 sterilized and control group (ANOVA statistical analysis and paired T-testing). The technology developed in Phase 1 will offer an alternative to methods of sterilization of soft tissue allografts used by tissue banks. Musculoskeletal conditions (diseases and disorders) have a tremendous impact on society. In the United States alone, musculoskeletal conditions cost society an estimated $254 billion yearly with 1 out of every 7 Americans reporting a musculoskeletal impairment. Each year, 28.6 million Americans incur a musculoskeletal injury with approximately 7.5 million musculoskeletal procedures performed by physicians. The importance of allograft tissue in the treatment of orthopedic patients has grown rapidly during the last decade. Tendon, ligament and joint injuries represent 45% of the musculoskeletal injuries each year. Tendon injuries are especially common, requiring surgical repair to replace shoulder rotator cuff tendons (51,000/year), achilles tendon (44,000/year), and the patellar tendon (42,000/year) to name a few. Concomitant with the increased demand for tissue has been the increase potential of exposures to pathogens. There is high potential for bacterial or viral contamination of allograft tissue without adequate secondary sterilization processing. Thus, the safety of allograft tissue has become a primary focus for the tissue bank industry, clinicians, and the FDA. Phase II funding will allow us to further optimize the sterilization process by addressing packaging (double packaging and header packs) as recommended by tissue banks and orthopedic surgeons. This packaging will result in a terminally sterilized product ready for direct transfer for transplant. The importance of allograft material in the treatment of orthopedic patients has grown rapidly during the last decade, which leads to a growing concern for an increased potential of exposure to pathogens. Viral and bacterial contamination of allograft tissue without adequate secondary sterilization processing remains an issue. Thus, the safety of allograft tissue has become a primary focus for the tissue bank industry, clinicians and the FDA. The tissue bank industry and processing centers have invested numerous hours and a large amount of money into methods of processing to achieve a high quality and safe. By providing a one step terminal sterilization process (sterilized grafts in final packaging), our company would be adding value and safety to the processing that occurs in the tissue bank industry. The only two processes capable of terminal sterilization of allografts are ethylene oxide and gamma irradiation which suffer from major drawbacks if used at a concentration to achieve SAL6 thus requiring a two step process to minimize the dosage. Terminal sterilization using our supercritical CO2 process has the potential to add a one step validated terminal sterilization process to tissue banking while decreasing the costs of processing and generating a safer product. Funding for Phase I has allowed us to show the feasibility of supercritical CO2 as a method of overcoming the current limited sterilization options. Funding of phase II will allow us to take the next steps towards successful commercialization by further optimization of packaging design (allowing for a terminally sterilized product of various sizes) and other pathogenic inactivation in soft tissue allografts.

* information listed above is at the time of submission.

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