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ALACHUA, Fla. -- Regeneration Technologies, Inc., the Florida-based processor of orthopedic, cardiovascular and other allograft implants, announces the launch of their patented BioCleanse Tissue Sterilization Process at the American Academy of Orthopedic Surgeons Annual Meeting in New Orleans. An innovation in tissue safety, RTI will deliver bone tissue labeled "Sterile" indicating that it meets or exceeds requirements for sterility assurance level (SAL) 10 -6 per AAMI and ISO Standards, providing the most complete measure of sterilization in the industry. RTI anticipates the first shipment of bone tissue labeled "Sterile" by March 1, 2003.
Current standard methods of sterilization and tissue processing, such as heat, irradiation, ethylene oxide, liquid chemical germicides and aseptic processing, may not provide complete removal of bacteria and viruses and/or have been recorded as compromising the biomechanical integrity or biocompatibility of allograft.
RTI, through their BioCleanse process, is redefining tissue sterility by exceeding FDA and current industry standards for sterile tissue processing. Since March of 2000, RTI has processed approximately 300,000 allograft implants with no incidence of recipient infection.
"BioCleanse has a proven track record of providing safe, high quality allograft implants," said C. Randal Mills, PhD, vice president of operations and R&D at RTI. "We are pursuing future innovations in BioCleanse to bring safe, high quality tissue to a broader patient base."
RTI processes allograft tissue into shaped implants for use in orthopedic, cardiovascular and other surgeries with a commitment to science, safety and innovation. By processing allograft tissue into forms that can be used in many types of surgical procedures, RTI enables patients to benefit from the gift of donated tissues. Allografts processed by RTI include the patented MD-Series threaded bone dowels, Cornerstone-SRTM blocks, OPTEFORM Moldable Allograft, OPTEFIL Allograft Paste, OSTEOFIL Allograft Paste Products, REGENAFIL and REGENAFORM Allograft Paste Products, FasLata fascia lata tissue, and cortical bone pins and interference screws.
RTI also holds the patent on the BioCleanse process, the only proven tissue sterilization process validated to eliminate viruses, bacteria, fungi and spores from tissue without impacting the structural or biomechanical integrity of the allograft.
Source: Regeneration Technologies, Inc.