Surgeons Report Clear Evidence for Strongly Recommending Sterile Tissue Implants Treated With the Clearant Process
Posted on: Tuesday, 4 April 2006, 09:00 CDT
Clearant, Inc. (OTCBB:CLRI) announced findings from a study by nine orthopedic surgeons in which the results led the surgeons to conclude that there is now clear evidence for strongly recommending sterile implants treated with the CLEARANT PROCESS. The results demonstrate the comparability, at six-month post-operative examinations, of a knee reconstructed using CLEARANT PROCESS-treated allograft with the patients' non-operated knee.
"This study and the surgeons' conclusions represent a significant milestone in our strategy to build market demand for sterilized tissue over non-sterilized tissue," said Alain Delongchamp, chief executive officer of Clearant. "Orthopedic surgeons can now provide their patients the safety of a sterile allograft, while knowing they are not compromising important post-operative factors such as strength and range of motion of the knee. Therefore, there is no reason to use anything but a CLEARANT PROCESS-treated allograft."
The multi-center study was performed by a diverse cross-section of orthopedic surgeons affiliated with professional sports organizations, leading research universities and sport injury clinics. During the recent American Academy of Orthopaedic Surgeons convention, the surgeons participating in the study discussed their findings, which showed that in patients who had undergone knee reconstruction using CLEARANT PROCESS-treated tissue, the strength and stability of the knee with the implanted tissue was comparable to the patients' non-operated knee at six-month post-operative examinations.
Dr. Philip Davidson of Tampa Bay Orthopedic Specialists stated: "I would prefer to use a CLEARANT PROCESS-treated graft in a family member, and would not typically recommend a non-sterile soft tissue allograft. Based on my positive experience and clinical follow-up over the last 16 months, I am confident that this sterilization technology is currently the best option for my patients." Dr. Davidson is a recognized innovator and educator in the field of Orthopedic Surgery, with an expertise in cartilage restoration and the use of allografts.
The surgeons participating in the multi-center study include:
-- Fred D. Cushner, M.D., Insall Scott Kelly Institute; New York, N.Y.
-- Philip A. Davidson, M.D., Tampa Bay Orthopedic Specialists; Pinellas Park, Fla.
-- Ty Endean, DO, Sports Institute of Tucson; Tucson, Ariz.
-- Peter Kurzweil, M.D., Southern California Center for Sports Medicine; Long Beach, Calif.
-- Chris Larson, M.D., Minnesota Sports Medicine; Eden Prairie, Minn.
-- Raffy Mirzayan, M.D., Kaiser Permanente-Baldwin Park; Baldwin Park, Calif.
-- Ronald Navarro, M.D., Kaiser Permanente-South Bay Medical Center; Harbor City, Calif.
-- Chris Proctor, M.D., Alta Orthopedics; Santa Barbara, Calif.
-- Steve Traina, M.D., Orthopedic Associates; Denver, Colo.
About Clearant, Inc.
Clearant, Inc. is a leader in pathogen inactivation for biological products. Clearant has developed the patent-protected CLEARANT PROCESS, which substantially reduces all types of pathogens in biological products while maintaining a high degree of the underlying protein. Whereas various competing sterilization methods only kill specific types of pathogens (such as bacteria or lipid-enveloped viruses) for specific products, the CLEARANT PROCESS reduces all types of pathogens for products across many market segments, including tissue implants, plasma proteins, recombinant products, medical devices and blood products. Also, the CLEARANT PROCESS can be applied at various stages of product processing and/or manufacturing, including in the final packaging. For more information, please visit www.clearant.com.
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 of 1995, in particular statements regarding surgeons strongly recommending the use of implants with tissue treated by the CLEARANT PROCESS, and the conclusions from a study by surgeons to build demand for sterilized tissue. 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, results of additional clinical studies, efficacy of the technology, intense competition and substantial regulation in the biotechnology industry, and additional risks discussed in the company's filings with the SEC, available on the SEC web site http://www.sec.gov.
Source: Business Wire
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