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Clearant, Inc. Comments on Single-Site Center for Disease Control Investigation

Posted on: Tuesday, 2 August 2005, 09:00 CDT

Clearant, Inc. (OTCBB: CLRI), the developer of the patent protected CLEARANT PROCESS(R) for pathogen inactivation, commented today on the results of a Center for Disease Control (CDC) study published in this month's Clinical Infectious Diseases (Crawford, et., al., July 2005).

Despite repeated and mounting evidence, a call-to-action first issued several years ago by the CDC remains, largely, stagnant. In an era of unprecedented demands for improvements and accountability in patient quality of care, the risk of poor outcomes, including death, is a reality for approximately 5% of patients who receive aseptically processed - or unsterilized - allograft implants. The threat of postoperative allograft - associated infections - which experts indicate is underreported given the historic absence of surveillance activities - was reaffirmed, once again, by this study.

The analysis, "Investigation of Postoperative Allograft-Associated Infections in Patients Who Underwent Musculoskeletal Allograft Implantation," found that the infection rate for patients who received aseptically processed allografts was 4.4% (11 of 250 patients), compared with 0% for patients who received autografts or sterile implants. Noting that the infection rate after ACL reconstructive surgery was less than or equal to 7 times the rate for other orthopedic procedures, the study authors repeatedly emphasized the urgency for tissue processors to adopt commercially available and validated sterilization technologies proven to eliminate the risk of contamination.

CLEARANT PROCESS(R) Treated Implants: Clinically Proven, Terminally Sterile... Every Time

As recently presented at the annual meeting of the American Orthopaedic Society for Sports Medicine, and as documented in more than 4,000 patient implants to date, the CLEARANT PROCESS(R) sterilization method virtually eliminated the pathogens that can cause post-operative surgical site infections. It is the only commercially available technology demonstrated to achieve the level of sterility required and provided by surgical and medical device suppliers and, importantly, it does so while maintaining the structural integrity and mechanical performance of the implant.

"When performing an allograft procedure, having a sterile implant gives me peace of mind in the operating room, knowing that my patient is receiving an allograft that has been treated with a superior technology and, consequently, is infection free. It allows me to give the patient what they want - the benefits of an allograft, including the smaller incision and quicker recovery, without the infectious risks seen with other allograft materials," said Fred Cushner, M.D., Beth Israel Medical Center and team physician for the New York Knicks.

From Donor to Recipient

Allografts, just like organs, are recovered from human cadavers, i.e., individuals who authorize donation of body parts and/or tissue upon their death. Following allograft recovery from the cadaver, one of several methods are then used to ensure risk of bacterial or viral contamination - from donor to recipient - is minimized. A few years ago, the safest way to do process tissues for implantation was through use of aseptic methods, in essence limiting the introduction of new organisms during the recovery and subsequent processing of donor tissue in a carefully controlled environment. However, even when treated with chemicals or antimicrobial agents meant to destroy bacteria, aseptic processing methods too often fail to kill lingering microorganisms, which can be buried deep in the tissue of the cadaver and, unknowingly, later transplanted into a recipient.

As concluded by the authors of the most recent CDC investigation, the results of which precisely mirror findings over several years, "patient safety is not assured when allograft tissues have not undergone a sterilization process."

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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