Clearant, Inc. Presents Additional Data on CLEARANT PROCESS(R) at Annual Meeting of the American Association of Tissue Banks
Posted on: Wednesday, 21 September 2005, 09:00 CDT
Clearant, Inc. (OTCBB: CLRI), the developer of the patent-protected CLEARANT PROCESS(R) for pathogen inactivation, announced today that it presented additional data demonstrating the effectiveness of the CLEARANT PROCESS(R) at this week's Annual Meeting of the American Association of Tissue Banks. Greg Bertenshaw, PhD, Clearant's Senior Director of Tissue Implant Development, discussed the results of a study in a presentation titled, "Sterilization of Allografts Employed in ACL Reconstructions: The Mechanical Strength, Biological Activity and Clinical Efficacy of Allografts Can Be Maintained Using Controlled High-Dose Gamma Radiation While Providing Robust Pathogen Inactivation."
The study's results demonstrated that the CLEARANT PROCESS(R), which employs controlled high-level irradiation doses on human tissue allografts while in the presence of radioprotectants and under low temperatures, significantly reduced pathogens without compromising the integrity and, most importantly, the clinical performance, of the soft tissue allografts used in ACL reconstructions. Uncontrolled and low doses of gamma radiation are ineffective in achieving a level of sterility equal to the standard of sterility required for medical devices due to the presence of radio-resistant bacteria (e.g. C. sordellii) in tissues.
In addition, there was no significant difference in the collagen integrity, mechanical strength, and biological activity of grafts irradiated to 50 kGy under the optimized, controlled conditions of the CLEARANT PROCESS(R) when compared to standard fresh frozen allografts - a key comparison when evaluating human tissue performance.
"We believe that our announcement yesterday, supporting the conclusion that controlled dose gamma irradiation utilized within the CLEARANT PROCESS(R) is the only technology that achieves final-packaging sterility levels equal to those of medical devices while maintaining tissue integrity, combined with today's results and our new Clearant Sterilization Service will increasingly drive tissue banks to employ our technology," said Alain Delongchamp, Chief Executive Officer of Clearant, Inc. "The very favorable response we received from tissue banks attending the conference suggests that recognition continues to increase on the role that the CLEARANT PROCESS(R) plays in the tissue industry."
The CLEARANT PROCESS(R) is the only final-packaging pathogen inactivation technology that offers tissue allograft sterility equal to medical device levels with no tissue damage or degradation. Clearant recently launched the new Clearant Sterilization Service, a new service based in Chicago, Illinois which processes pre-treated allograft tissue for tissue banks using the CLEARANT PROCESS(R).
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.
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. 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.
Source: Business Wire
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