Healthcare Industry News: ACL reconstruction
News Release - September 12, 2006
Clearant Presents Patient Data at One Year Post Surgery Showing Complete Recovery of Range of Motion for Patients Implanted with Sterile Clearant Process(R) TissueClearant presents new patient data following ACL reconstructive surgery at American Association of Tissue Banks Annual Meeting
LOS ANGELES--(HSMN NewsFeed)--Sept. 12, 2006--Clearant, Inc. (OTC BB: CLRI ) today announced that Phil Davidson, M.D., orthopedic surgeon at Tampa Bay Specialty Surgery Center presented clinical performance data on Clearant ProcessŪ implants at the American Association of Tissue Banks (AATB) Annual Meeting this week in San Diego.
The new study concluded that allograft implants sterilized by the Clearant Process achieved full recovery of range of motion at one year; the study evaluated two groups of patients who underwent ACL reconstruction surgery and the results were statistically equivalent despite the fact that the study examined the non-sterile implant group at 24 months post-op, offering further recovery time, as opposed to 12 months post-op for the sterile Clearant Process group. The Clearant Process implants protected the recipients from the risk of bacterial and viral transmission including HIV, Hepatitis B, Hepatitis C and West Nile Virus transmission.
"Our data indicates that the Clearant Process implants allow patients to achieve a complete range of motion recovery from surgery as early as 12 months post surgery without the risk of infections," commented Dr. Davidson.
The study evaluated 49 patients at 12 months post operatively following ACL surgery with tissue treated with the Clearant Process. The control group for this comparison was data from the two year mark following surgery from patients who received conventional, non-sterilized tissue. All tests were performed according to International Knee Documentation Committee standards, the stability and strength of the Clearant Process treated allograft group were comparable to the control group.
"The recent events in the tissue industry continue to underscore the need for pathogen inactivation technologies that will protect patients against the risk of bacterial or viral infection associated with allograft tissue implants. Patients undergoing ACL reconstructive surgery deserve the assurance that their allograft implant is free of all bacteria and viruses," commented Alain Delongchamp, CEO of Clearant. "By offering a Clearant Process sterile implant with favorable patient outcomes, surgeons can offer peace of mind to their patients."
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 bacteria and viruses in biological products while maintaining the functionality of the underlying tissue implant or protein. The Company began to distribute directly to surgeons, hospitals and clinics Clearant Process sterile implants in June 2006; in addition, Clearant continues to license the Clearant Process and provides its patented sterilization services to tissue banks and other biological products manufacturers. As of the end of 1Q 2006, Clearant had 10 license and service agreements with tissue banks. To date more than 8,000 patients have been successfully implanted with Clearant Process sterile implants supplied by one of the Company's licensed partners. 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.
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.
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