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Tissue Banks International First in U.S. to License Advanced Sterilization Technology to Improve the Quality and Safety of Tissue Transplantations

CLEARANT PROCESSTM Aims to Set New Safety Standard for Processing Donated Tissues Used in Thousands of Medical Procedures Each Year

Tissue Banks International (TBI), a non-profit provider of tissues for orthopedic, spinal, sports medicine, and urologic surgery has finalized an agreement with Clearant, Inc. to license the company’s patented pathogen inactivation process to prevent the transmission of all types of pathogens (viruses, bacteria, mold, spores, etc.) in donated tissue.

TBI will be the first U.S. tissue bank to license the CLEARANT PROCESSTM, which uses a novel set of conditions designed to apply higher levels of controlled ionizing irradiation to destroy all types of pathogens (both known and emerging, but as yet unidentified), while maintaining the integrity and functionality of the biological product. Unlike other techniques, the CLEARANT PROCESSTM completely penetrates tissues and can be applied at any stage of product processing, including the final container sterilization step. These unique advantages make it the only pathogen inactivation process that promises to allow tissue providers to substantiate a sterilization claim. Equally important, the process involves no toxic or carcinogenic chemicals.

“TBI’s mandate has always been to employ the highest safety standards in the processing of tissues for transplantation and our unblemished track record is a reflection of this,” said James Forsell, Ph.D., Executive Vice-President, TBI. “However, in light of reports over the past year of infections potentially caused by pathogens in tissues, we believe we have a duty to pursue new advanced sterilization technologies that more fully protect recipients of donated tissues from contaminants that we know exist and can be transmitted today, as well as those that may exist in the future.”

Building the Case for Improved Tissue Sterilization

Tissue banks distribute approximately 750,000 tissue specimens each year with few reports of serious complications. However, providers of donated tissue have been under increased scrutiny by regulatory authorities, the medical community, and the public following the reported death in November 2001 of a recipient of an allograft (tissue transplant) from a non-TBI tissue contaminated with Clostridium sordellii (an anaerobic spore and toxin-forming organism) and of 54 similar non-TBI related cases investigated by the Centers for Disease Control and Prevention (CDC). These cases prompted the CDC, following a 2002 Morbidity and Mortality Weekly Report (MMWR), to suggest that the tissue industry adopt more stringent aseptic processing and to implement, “when possible”, a method that terminally sterilizes tissue.

“Its agreement with Clearant reflects TBI’s desire to go beyond current processing safety standards when advanced technologies become available and can be validated in order to continually fulfill its mission of maximizing the use of the precious gift of donated tissues,” said Alain Delongchamp, Chief Operating Officer, Clearant, Inc., Los Angeles, CA. “We are honored to be part of this partnership with TBI, which is clearly setting a new standard that will elevate the quality and safety of tissue processing in the United States.

About TBI and Clearant

Tissue Banks International is a non-profit network of eye and tissue banks. The network provides corneas and other eye tissue for sight-restoring transplant surgery. TBI also recovers such tissues as bone, ligaments and tendons (musculoskeletal tissue) that restore mobility, as well as skin used in burn and reconstructive surgery, heart valves to correct cardiac conditions, and saphenous veins to remedy circulatory problems.

Clearant, Inc., a global biotechnology company headquartered in Los Angeles, California, aims to be the leader in single step inactivation of all types of pathogens for biological products. Clearant, Inc. has developed the first, true pathogen inactivation technology for biological products, the CLEARANT PROCESS™. Until now, no technology has been capable of destroying all types of pathogens in biological products, even emerging ones yet to be identified. Various sterilization methods on the market today kill specific types of pathogens, such as bacteria or lipid enveloped viruses, for specific products. The CLEARANT PROCESS ™ inactivates all types of pathogens for products across many market segments including plasma proteins, tissue implants, recombinant products and blood products.

For more information, visit www.clearant.com