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Clearant Announces Presentation of Clinical Data on the CLEARANT PROCESS(R) By Dr. Fred Cushner at Annual Meeting of the European Association of Tissue Banks

Posted on: Monday, 12 December 2005, 09:00 CST

Findings Demonstrate High Doses of Gamma Irradiation Do Not Compromise the Structural or Biological Integrity of Human Soft Allograft Tissues when Sterilized under the conditions of the CLEARANT PROCESS(R)

Clearant, Inc. (OTCBB: CLRI), the developer of the patent-protected CLEARANT PROCESS(R) for pathogen inactivation, announced that Dr. Fred Cushner delivered a presentation entitled "The Clinical Efficacy of Allografts Sterilized by High Doses of Gamma Irradiation" at the Annual Meeting of the European Association of Tissue Banks in Florence, Italy on December 10, 2005. The presentation reviewed the six-month results of a multi-center study. Preliminary results of 55 patients receiving allografts treated with the CLEARANT PROCESS(R) in anterior cruciate ligament (ACL) surgeries showed a 94.5% success rate with a return of normal function, range of motion and minimal effusion.

The study, which currently has eight surgeons throughout the United States, tracks the post-operative results of patients who received human soft allograft tissue that had been treated with the CLEARANT PROCESS(R). Study evaluations include failure rate, range of motion, and joint effusion (swelling) among other metrics which had been previously established by the clinical study committee prior to the start of the study. The demonstrated failure rate at this point in the study is in line with the anticipated failure rate among other non-CLEARANT PROCESS(R)-treated soft tissue allografts that have been used for implantation and is significantly lower than a 26.7% failure rate among allografts that were treated with uncontrolled (22- 25 kGy) doses of gamma radiation (2005, Dr. Rappe, et. al.).

"The in vivo success of the CLEARANT PROCESS(R) to inactivate viral and bacterial pathogens makes this technology a critical element of the processing of human soft tissue allografts which, in turn, provides sterile allografts to the surgical field," said Dr. Fred Cushner, lead investigator of the multi-center study and presenter of the data at the Annual Meeting of the European Association of Tissue Banks. "It has been previously demonstrated, by laboratory and animal testing, that the tissue allografts are not mechanically or biologically compromised with this sterilization solution, and as a result, the benefits of tissue treated with the CLEARANT PROCESS(R) are clear. These results are encouraging and are another step in achieving the safety and efficacy that our patients demand."

The CLEARANT PROCESS(R) is the only current commercially available pathogen inactivation technology applied to allograft tissue in its final packaging which renders the allograft as sterile as a medical device while maintaining tissue integrity. In addition to the sterility achieved in human soft tissue using the CLEARANT PROCESS(R), laboratory and animal tests have shown an equal success rate when the CLEARANT PROCESS(R) is applied to human bone, providing sterility levels in line with medical device standards and with very little bone damage or degradation.

The presentation can be viewed at www.clearant.com.

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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