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March 31, 2006
NovaSterilis’ NOVA 2200 Supercritical Carbon Dioxide Sterilization Technology is Chosen by Community Tissue Services for In-House Sterilization of Transplant Tissue
ITHACA, NY - NovaSterilis, Inc., a developer and provider of advanced medical sterilization technology, announced the commercial launch to the tissue bank industry of its NOVA 2200™ Sterilization System by placing the first unit with Community Blood Center/Community Tissue Services (CBC/CTS) of Dayton, OH.
The NOVA 2200™ System employs supercritical carbon dioxide in a patented process to sterilize biomedical materials. Sterilization of human allograft (transplant) tissue, with 12-log reduction in bioburden or SAL 10-6 levels, is achieved without compromising the structural integrity of transplanted tendon, skin, and bone. Besides sterilizing packaged tissue allografts at comparatively lower cost per run, the NOVA 2200™ System also meets tissue bank requirements for providing safer tissue transplant products within an economically advantageous cost structure. NovaSterilis is also developing the NOVA 2200™ System for applications beyond the sterilization of musculoskeletal tissue, including sterilization of certain medical devices, biological products, and pharmaceuticals where there are issues with the use of other sterilization technologies.
With the NOVA 2200™ System, human transplant tissue can be treated in the customer’s own facility. This “in-house” processing of graft material also eliminates the delay, cost and risk associated with shipping material to a contract sterilization facility and then back to the processors for distribution to hospitals and clients.
“Developing a system capable of terminal sterilization of critical tissue allografts to FDA-approved levels has been our mission at NovaSterilis,” said David C. Burns, CEO of NovaSterilis. “The tissue bank industry is very interested in technology that can be developed and employed to reduce the risk of infection. The industry cares deeply about making transplant surgery an increasingly safer procedure, and our technology can certainly help in that endeavor.”
“CTS is excited to be working with NovaSterilis to apply this new technology to allograft musculoskeletal tissues”, said David M. Smith, M.D., Medical Director of CBC/CTS. “We feel that the NovaSterilis process will allow us to provide safe tissue without the use of gamma irradiation.”
Current methods of sterilization include ethylene oxide, gamma radiation, electron-beam, steam, and hydrogen peroxide plasma, all of which alter the structure and integrity of biological tissues. The allograft tissue market in the United States has been estimated at approximately $1 billion in 2005, and is forecast to grow 15-20% annually.
About NovaSterilis: NovaSterilis, Inc., which developed the NOVA 2200™ System, is a privately held biotechnology company located in Ithaca, NY near Cornell University. NovaSterilis develops and commercializes proprietary supercritical carbon dioxide-based products and technologies for the sterilization of biomedical materials, thereby addressing challenging issues facing the pharmaceutical and biomedical industries. The Company’s proprietary technologies grew out of the internationally acclaimed research conducted by Professor Robert S. Langer and his team at MIT. For more information about NovaSterilis or the NOVA 2200™ System, please visit the Company’s website at www.novasterilis.com or call 607.330.2772.
About Community Blood Center/Community Tissue Services: Community Blood Center/Community Tissue Services (CBC/CTS), an independent, not-for-profit organization, is ISO 9001:2000 Registered. Community Tissue Services serves the public through recovery, processing and distribution of human tissue donations used for transplantation. Community Tissue Services is comprised of eight regional offices: Dayton, Ohio (Corporate Headquarters); Fort Worth, Texas; Fresno, California; Indianapolis, Indiana; Portland, Oregon; Philadelphia, Pennsylvania; Toledo, Ohio and Memphis, Tennessee with satellite offices in Boise, Idaho, Medford, Oregon and Connersville, Indiana. For more information about Community Blood Center/Community Tissue Services, visit www.cbccts.org.
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