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Journal of Orthopaedic Research Reports Clearant Process Sterilization Reduces Infectious Risks in Soft Tissue Allografts, Maintains Biomechanical Performance

Posted on: Thursday, 15 June 2006, 09:01 CDT

Results Anticipated to Assist Clearant Ramp Up of Direct Distribution of Soft Tissue Implants to Sports Medicine Surgeons

Clearant, Inc. (OTCBB:CLRI) today announced that positive results from a study examining the safety and biomechanical integrity of tissue sterilized with the Clearant Process were published recently in the Journal of Orthopaedic Research (Volume 24, Issue 5). The study concluded that the Clearant Process method of terminal sterilization -- gamma irradiation (50kGy dose) under controlled conditions and following a treatment with radio-protective solution -- can virtually eliminate infections risks associated with soft tissue allografts while maintaining the pre-implantation biomechanical performance of the tissue. The Clearant Process is the first method capable of substantially reducing all types of pathogens in tissue implant sterilized in its final packaging, while maintaining the integrity of the essential underlying protein in the tissue.

"Any pathogen inactivation method for allografts should provide the broadest and greatest reduction in infectivity while preserving the biomechanical and biological properties of the tissue. The benefits of sterilization using irradiation are well-known. However, past attempts to sterilize allograft tissues with gamma irradiation have had an adverse effect on tissues' biomechanical properties or the dose of gamma irradiation was not sufficient to sterilize the tissue," commented one of the study's authors, Dr. Jack Lin, and prior staff scientist for Clearant. "In this study, we've demonstrated that tendon allografts irradiated under the specific conditions of the Clearant Process actually do deliver sterile implants that exhibit favorable biomechanics. The development of such a sterilization method that does not adversely affect tissue function provides added safety to tissues for transplantation."

The investigation examined 28 semitendinosus tendons from donors, ages 15-55 years. The tendons were assigned to a non-irradiated non-sterile control group and the Clearant Process sterile group, and then compared for biomechanical integrity. Pathogen inactivation was also quantified. Additionally, the groups were compared to tendons that had been irradiated to 18 kGy, standard practice at some commercial tissue banks. Key findings include:

-- No difference was generally detected in the preimplantation biomechanical properties of sterile tendons treated by the Clearant Process when compared to non-sterile, non-irradiated tendons.

-- The inactivation of model viruses for HIV, Hepatitis C and West Nile Virus demonstrates that the Clearant Process substantially reduces the risk of viral transmission

-- The bacterial inactivation achieved with the Clearant Process clearly exceeds the FDA minimum requirement for sterility of medical devices; these results demonstrate the power of the Clearant Process.

"This important study provides additional compelling evidence showing that allografts treated with the Clearant Process demonstrate comparable strength and functionality to conventional allografts while significantly reducing the risk of infection. We anticipate that these results will spark a corresponding increase in the adoption of Clearant Process soft tissue implants among surgeons and their patients," said Alain Delongchamp, chief executive officer for Clearant. "The Clearant Process has the potential to bridge the growing divide between supply and patient demand for sterile tissues for transplantation by combining the safety of autograft implants with the convenience of allograft implants."

Clearant previously reported findings from a multi-center investigation to evaluate the post implantation mechanical and biological performance of grafts. The results of that study demonstrated comparable strength and stability, at six-month post-operative examinations, of a knee reconstructed using Clearant Process-treated allograft with the patients' non-operated knee.

About the Journal of Orthopaedic Research

The official publication of the Orthopaedic Research Society, the Journal of Orthopaedic Research provides a forum for rapid publication of high quality manuscripts reporting new information on basic science, bioengineering and clinical aspects of orthopaedic research. Manuscripts reporting new information on the composition, structure, and material properties of tissues important to orthopaedics are appropriate, as are prospective clinical studies in which multidisciplinary approaches are used to provide methods and standards for diagnosis, treatment, and evaluation of clinical results.

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 pathogens in biological products while maintaining the functionality of the underlying protein. The Company plans to distribute directly to surgeons, hospitals and clinics Clearant Process sterile implants starting mid 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 a 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.

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, 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.

Source: Business Wire

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