CryoLife Selects Clearant, Inc. to Sterilize Implant of its Cryopreserved Orthopaedic Tissues; Leading Tissue Bank Adopts The CLEARANT PROCESS-R- For The First Time.ATLANTA -- Clearant, Inc., (OTCBB OTCBB See OTC Bulletin Board (OTCBB). : CLRI) the developer of the CLEARANT PROCESS(R) for pathogen inactivation announced today that CryoLife, Inc. (NYSE NYSE See: New York Stock Exchange : CRY), a biomaterials and biosurgical device company, had completed their first human implant of its cryopreserved orthopaedic tissues utilizing the CLEARANT PROCESS(R). The CLEARANT PROCESS(R) is the most widely licensed method available to sterilize tissue allograft allograft: see transplantation, medical. implants in their final packaging. The process was applied by CryoLife to tissues for implant in a patient to reconstruct the anterior cruciate ligament anterior cruciate ligament n. Abbr. ACL The cruciate ligament of the knee that crosses from the anterior intercondylar area of the tibia to the posterior part of the lateral condyle of the femur. (ACL See access control list. 1. ACL - Access Control List. 2. ACL - Association for Computational Linguistics. 3. ACL - A Coroutine Language. A Pascal-based implementation of coroutines. ["Coroutines", C.D. ) and the posterior cruciate ligament posterior cruciate ligament n. Abbr. PCL The cruciate ligament of the knee that crosses from the posterior intercondylar area of the tibia to the anterior part of the medial condyle of the femur. (PCL (Printer Command Language) The page description language for HP LaserJet printers. It has become a de facto standard used in many printers and typesetters. PCL Level 5, introduced with the LaserJet III in 1990, also supports Compugraphic's Intellifont scalable fonts. ) in his knee. CryoLife plans to make available cryopreserved patellar patellar of or pertaining to the patella. patellar cartilage a cartilaginous process borne on the medial side of the patella of horses and cattle. , tibialis tibialis /tib·i·a·lis/ (tib?e-a´lis) [L.] tibial. tibialis [L.] tibial. , achilles, quadricep, and peroneus tendons treated with the Clearant Process to orthopaedic surgeons for knee reconstruction surgery. "The adoption by CryoLife of the CLEARANT PROCESS(R) represents an important validation of the technology and its role in pathogen activation," said Alain Delongchamp, Chief Executive Officer of Clearant, Inc. "With implementation of FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. guidelines anticipated for later this month which encourage terminal sterilization, we applaud CryoLife's decision to be pro-active in this process. We believe that its actions will pave the way for other tissue banks and processors to take the prudent and safe approach to terminal sterilization by employing our process." The CLEARANT PROCESS(R) is a patented technology based on gamma irradiation and a radioprotectant that is designed to inactivate pathogens, including microorganisms, while maintaining tissue integrity. To date, more than 2,500 patients in the U.S. have benefited from CLEARANT PROCESS(R) treated implants. Dr. David Caborn performed the surgery at Jewish Hospital in Louisville, Kentucky. Dr. Caborn said, "I have worked with CryoLife for several years transplanting their cryopreserved musculoskeletal tissues to reconstruct painful, unstable knees. The CLEARANT PROCESS(R) provides surgeons the opportunity to use irradiated orthopaedic tissue without compromising the tissue's strength and structural properties, while inactivating pathogens." "The implant of our first cryopreserved orthopaedic tissue treated with the CLEARANT PROCESS(R) and the recent implant of our cryopreserved osteoarticular (OA) allografts allografts (al´ n.pl the transplantation of tissue between genetically nonidentical individuals of the same species. are evidence of CryoLife's ongoing commitment directed toward the surgical repair and reconstruction of sports injuries," stated Steven G. Anderson, President and CEO of CryoLife, Inc. "Since CryoLife was founded in 1984, more than 100,000 patients have received our cryopreserved human tissue for reconstructive cardiac, vascular, and orthopaedic surgeries. CryoLife continues to develop innovative biotechnologies, which are designed to improve the safety and availability of human tissues for implant." About Clearant, Inc. Clearant, Inc., a biotechnology company headquartered in Los Angeles, California, is a leader in pathogen inactivation for biological products. Clearant, Inc. has developed the patent protected CLEARANT PROCESS(R) , designed to substantially reduce all types of pathogens in biological products while maintaining a high degree of the underlying protein. Various sterilization methods on the market today only kill specific types of pathogens, such as bacteria or lipid-enveloped viruses, for specific products. The CLEARANT PROCESS(R) can substantially reduce all types of pathogens for products across many market segments including plasma proteins, tissue implants, recombinant products and blood products, and can be applied at various stages of product processing/manufacturing, including in the final container. Clearant's revenue includes fees from licensing its patented technology and research and development fees generated on projects for commercial customers and government grants. The CLEARANT PROCESS(R) is marketed through a direct sales force primarily in the United States and in Europe. Forward-Looking Statements Except for statements of historical fact, the matters discussed in this press release are forward looking and made pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995. These forward-looking statements reflect numerous assumptions and involve a variety of risks and uncertainties, many of which are beyond the company's control, which may cause actual results to differ materially from stated expectations. These risk factors include, among others, limited operating history, difficulty in developing, exploiting and protecting proprietary technologies, intense competition and substantial regulation in the biotechnology industry, and additional risks discussed in the company's filings with the SEC. For more information about Clearant, Inc., please see www.clearant.com. |
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