:LifeTek, Inc. and DCI Donor Services License New Technology to Terminally Sterilize Tissues Used in Thousands of Medical Procedures Annually
@head:LOS ANGELES -- Two additional major tissue recovery and processing organizations -- LifeTek, Inc. and DCI Donor Services -- have finalized agreements with Clearant, Inc. to license the company's patented pathogen inactivation process in order to begin providing hospitals and patients with safer, sterile tissue allografts. Prior to the introduction of the Clearant Process, tissues were aseptically processed because there was no technology available that allowed tissue banks to significantly eliminate the risk of pathogen transmissions and terminally sterilize tissues without damaging the function of the allograft.
"As a new organization, we wanted to make sure we entered the tissue processing marketplace employing the most advanced technology in order to provide physicians and patients with the safest products possible, and, for us, 'safest' equals 'sterile'," said Gene Elliot, chief operating officer of LifeTek, Inc. "The Clearant Process not only helps us more fully protect patients, the company also shares in our commitment to innovation, which makes us confident that the quality and safety standards we implement today will be the industry standards in the future."
The Clearant Process is the only current pathogen inactivation technology that substantially reduces all types of pathogens, including bacteria and viruses, which may be present in human tissue without compromising the quality of the tissue. In addition, the Clearant Process, based on gamma irradiation, is designed to be used for allograft tissue in the final container, thereby allowing the final product to be "terminally sterile" for use in the operating room. Currently allografts being delivered to hospitals for use in tissue transplants are aseptically processed -- washed and then packaged in a clean environment -- and, therefore, cannot claim sterility.
"As one of the oldest tissue banks, DCI Donor Services has a longstanding commitment to employing and adhering to the highest quality and safety standards," said John Lee, executive director of DCI Donor Services. "We also recognize the inherent risks, no matter how remote, that come with not being able to offer sterile tissues and do everything possible to prevent infection. Therefore, we are pleased to be able to work with Clearant to enhance our efforts to terminally sterilize tissues."
Tissue banks distribute approximately 750,000 tissue specimens each year with few reports of serious complications. However, processors of donated tissue continue to be under increased scrutiny by regulatory authorities, the medical community and the public following the reported death in late 2001 of a tissue transplant recipient, as well as a rash of infections and recalls of tissue by processors in 2002. In addition, the Centers for Disease Control and Prevention (CDC), following the death and subsequent infections, has suggested that the tissue industry adopt more stringent aseptic processing and to implement, "when possible," a method that terminally sterilizes tissue.
"Even before the infections and recalls, many tissues banks routinely evaluated their quality and safety systems to determine if there were ways to improve them and further reduce the risk of contamination and infections, and so most have been very receptive to discussions once they have seen our results," said Alain Delongchamp, chief operating officer of Clearant, Inc. "LifeTek, Inc. and DCI Donor Services are among the first to finalize agreements with Clearant, but given the acceleration in talks with many other tissue banks we believe this is just the tip of the iceberg."
Expected to be fully operational in summer 2003, LifeTek, Inc. is dedicated to the manufacturing and global distribution of tissues that are processed under conditions utilizing technologies and processes proven to be the most superior in the industry, thus ensuring that physicians and their patients will receive human tissue products that fulfill the highest quality and safety standards in the marketplace.
Source: Clearant, Inc.