Clearant Expands Leading Clinical Follow-Up Position -- Zero Failure Rate Results in Recent Study
Posted on: Thursday, 6 April 2006, 12:00 CDT
Clearant, Inc. (OTCBB:CLRI) announced findings from a study by Dr. Ty Endean of the Sports Institute of Tucson which had a zero failure rate for knees reconstructed using sterilized CLEARANT PROCESS-treated allografts during extensive 9-month post-operative examinations.
"The study's conclusion strongly supports my recommendation to use allografts sterilized with the CLEARANT PROCESS," said Dr. Ty Endean, Founding Physician and Director of the Sports Institute of Tucson. Dr. Endean is a member of the medical staff for the United States Rugby Team and was an orthopedic physician in the USA 2003 Rugby World Cup. He is the team physician for the Arizona Heat, a women's professional softball team. Dr. Endean was a fellow at the Palo Alto Medical Center, led by Dr. Warren King, where he was part of the medical staff for the Oakland Raiders.
"Patients were assessed on a wide range of parameters, including range of motion, laxity, alignment, functional exam, and instance of failure. No failure was exhibited at the post-op follow-up examinations for both the CLEARANT PROCESS and control groups, providing strong evidence that the CLEARANT PROCESS does not impact the functional properties of the tissue. Also, the CLEARANT PROCESS provided microbial sterility and viral reduction, greatly reducing the risk of disease transmission. This is the allograft of choice," said Dr. Endean.
In this single-center study of 82 knee reconstruction patients, 28 had received conventional allograft tissue (the control group) and 54 had received implants treated with the CLEARANT PROCESS. In their nine-month post-operative examinations, patients with the Clearant-treated tissue demonstrated stability and functionality comparable to the control group at their 15-month post-operative exam. In addition, there was no statistically significant post-op difference in effusion between the control and study groups.
"This report mirrors the positive findings we recently announced from an earlier multi-center study," said Alain Delongchamp, chief executive officer of Clearant. "These studies continue to make the case that when all aspects of patient well-being are considered, there is simply no reason to use anything but CLEARANT PROCESS-treated sterilized tissue when a knee reconstruction procedure requires an allograft."
The research by the Sports Institute of Tucson represents the second study this year demonstrating the effectiveness of sterile allografts treated with the CLEARANT PROCESS for knee reconstruction procedures. Previously, Clearant announced findings from a nine surgeon multi-center study 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. Clearant is committed to supporting research that promotes the Food and Drug Administration's Good Tissue Practices.
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. 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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