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CORRECTING and REPLACING Human Experience Demonstrates That CLEARANT PROCESS(R) Treated Tissue Allograft Implants Improve ACL Reconstructive Surgery Results; Results in 70 Patients Shows 0% Rate of Infection

Posted on: Tuesday, 26 July 2005, 12:01 CDT

Please replace the release due to multiple revisions with the following corrected version.

The corrected release reads:

HUMAN EXPERIENCE DEMONSTRATES THAT CLEARANT PROCESS(R) TREATED TISSUE ALLOGRAFT IMPLANTS IMPROVE ACL RECONSTRUCTIVE SURGERY RESULTS; RESULTS IN 70 PATIENTS SHOWS 0% RATE OF INFECTION

Clearant, Inc., (OTCBB: CLRI) the developer of the patent protected CLEARANT PROCESS(R) for pathogen inactivation, announced today results from a one-year clinical evaluation of 70 patients undergoing anterior cruciate ligament (ACL) reconstructive surgery using tissue allograft implants treated by the CLEARANT PROCESS(R), a terminal sterilization technology that virtually eliminates the pathogens that can cause post-operative surgical site infections. The results in 70 patients showed that there was a 0% infection rate; these results demonstrate a far superior degree of safety for patients compared to the infection rate observed for patients implanted with currently available, non-sterile tissue allograft implants treated with low dose gamma irradiation or aseptically processed. The results announced today are consistent with the data from more than 4,000 patients implanted with soft tissue allograft implants using the CLEARANT PROCESS sterilization technology and were reported at the Annual Meeting of the American Orthopaedic Society for Sports Medicine.

Of the 70 recipients whose average age was 32 years, 63 patients had excellent outcomes and only 6 had failures (8.6%); these 6 patients were considered to be unusually very active, which could explain the reason for the failures. The results were comparable to the historical average allograft failure rate of 7.3% for non-irradiated, non sterile achilles implants (Siebold, et al, Arch Orthrop Trauma Surg, 2003).

In addition, today's reported human outcome evaluation, Clearant previously conducted extensive static and cyclic mechanical integrity testing on over 1,000 tissue allograft implants treated with the CLEARANT PROCESS(R). Also, a number of independent animal studies were conducted. Each independent animal study demonstrated that the biological activity of the CLEARANT PROCESS(R) treated implant allograft implants was maintained.

Studies by Clearant have also shown that the dose used by several tissue allograft implant providers in the USA (low-dose gamma irradiation at 18 Kgys) is not adequate to achieve a validated 10-6 sterility claim (the industry standard for medical devices) in tissue allograft implants for all types of bacteria including resistant bacteria such as clostridium species.

According to the Clinical Infectious Diseases study on allograft infections (July 15, 2005), "patient safety is not assured when allograft tissues have not undergone a sterilization process." In fact, the study states that "the infection rate for aseptically-processed allografts was 4.4%, compared with 0% for patients who received autografts or sterile allografts." Dr King's patients did not experience any infection related to the use of sterile CLEARANT PROCESS treated implants.

Currently, seven tissue processors have licensed the CLEARANT PROCESS(R) for allograft tissue sterilization.

Dr. King's study, published in a paper titled "Microbial Sterilization and Viral Inactivation in Soft Tissue Allografts Using High-Dose Gamma Irradiation: Report of a New Graft Preparation Technique and One-Year Clinical Follow-Up.

About The American Orthopaedic Society for Sports Medicine

The American Orthopaedic Society for Sports Medicine, a world leader in sports medicine education, research, communication, and fellowship, is a national organization of orthopaedic sports medicine specialists, including national and international sports medicine leaders. The Society works closely with many other sports medicine specialists and clinicians, including family physicians, emergency physicians, pediatricians, athletic trainers, and physical therapists to improve the identification, prevention, treatment, and rehabilitation of sports-related injuries.

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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