ALACHUA, Fla., July 19 /PRNewswire-FirstCall/ -- Regeneration Technologies, Inc. (RTI), the Florida-based processor of orthopedic, cardiovascular and other allograft implants, announced today that it has passed the half-million mark in distributing implants sterilized through its patented BioCleanse(R) tissue sterilization process. Since its implementation in March 2000, more than 540,000 allograft implants sterilized through BioCleanse have been distributed for implantation nationwide with zero incidence of graft-related infection.
Disease transmission and bacterial infection through transplantation of human donor tissue, or allograft, is a very real risk. Standard methods to prepare tissue for transplant include screening for diseases, bacterial testing and aseptic processing, all of which help to significantly reduce the risk to patients. According to a recent study published in The New England Journal of Medicine (NEJM), however, these methods are not sufficient to eliminate risk of allograft-associated infections in recipients.
The published study was initiated by the Centers for Disease Control and Prevention (CDC) in 2001, after the death of a 23-year-old man who had received an allograft implant contaminated with Clostridium sordellii, a common spore that resides in the intestinal tract and can be transmitted to tissue recipients, causing life-threatening infection. The study concludes, “Sterilization methods that do not adversely affect the functioning of transplanted tissue are needed to prevent allograft infections.”
Lennox K. Archibald, M.D., FRCP, supervised the CDC investigation and was the senior author of the NEJM article, which had been cleared by CDC before it was submitted for publication. Archibald left CDC for the United Kingdom after submitting the manuscript to NEJM. In 2003, Archibald returned to the United States and became the medical director of RTI.
“The message of the CDC study is that while bacterial infection is a relatively uncommon complication in tissue transplantation, the increasing use of musculoskeletal tissue allografts in various surgical procedures represents a real health risk to recipients of tissue that has not undergone a sterilization process.” Archibald said. “This study proves that aseptic processing of tissue alone is not adequate to enhance patient safety -- tissue banks must find a way to include a sterilization step, like the BioCleanse process, in their tissue processing methods.”
RTI holds the patents on BioCleanse, the only proven tissue sterilization process validated to eliminate viruses, bacteria, fungi and spores from tissue without impacting the structural or biomechanical integrity of the allograft.
“We invented BioCleanse with the idea that through science we can provide surgeons and their patients with sterilized implants they know are safe,” said Brian K. Hutchison, RTI chairman, president and chief executive officer. “Donor families entrust us with their gift of donation because they know through our innovations, we will serve as responsible stewards of each gift by safely helping as many people as possible. We take these responsibilities to our patients, surgeons and donor families very seriously, and therefore we are committed to raising the bar in science, safety and innovation.”
About Regeneration Technologies, Inc.
RTI processes allograft tissue into shaped implants for use in orthopedic, cardiovascular and other surgeries with a commitment to science, safety and innovation. By processing allograft tissue into forms that can be used in many types of surgical procedures, RTI enables patients to benefit from the gift of donated tissues.
RTI is accredited by the American Association of Tissue Banks and was named a 2004 Technology Pioneer by the World Economic Forum.
Except for historical information, any statements made in this press release about the company’s anticipated financial results, future operational results or regulatory approvals are forward-looking statements subject to risks and uncertainties such as those described in the company’s public filings on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results reflected in these forward- looking statements. Copies of the company’s SEC filings may be obtained by contacting the company or the SEC or by visiting RTI’s web site at http://www.rtix.com/ or the SEC’s web site at http://www.sec.gov/.
Background Information
* The BioCleanse difference is that it is a low-temperature chemical sterilization process, proven to eliminate risk of donor-to-recipient infection or disease transmission. Before the advent of BioCleanse, effective tissue sterilization was not thought to be possible, as typical sterilization methods such as irradiation, heat or ethylene oxide can degrade the structural integrity of tissue. Additionally, BioCleanse effectively removes blood and other cellular material from the tissue, allowing for a safer, higher quality implant.
* The study published in the June 17, 2004 issue of The New England Journal of Medicine article underscores the importance of the BioCleanse(R) process in enhancing patient safety:
One tissue bank has developed and implemented a low-temperature chemical- sterilization approach (BioCleanse) that kills spores but preserves the biomechanical integrity and function of some allografts.35-37 The efficacy of this sterilization method is supported by the absence of reports of bacterial or viral allograft-associated infections in tissue processed by this method (CDC: unpublished data). In contrast, tissues processed with all other disinfection and sterilization methods, including gamma irradiation, have been associated with reports of allograft-associated infections (CDC: unpublished data).
* In June, RTI announced the availability of musculoskeletal soft tissue sterilized with the BioCleanse process through its exclusive distributor in the U.S., Stryker Endoscopy.
* C. Thomas Vangsness, Jr., M.D., a professor of orthopedic surgery at the University of Southern California’s Keck School of Medicine, is participating in a study evaluating the efficacy of soft tissue allografts sterilized through the BioCleanse process.
“Allograft tissue is many times the only option for sports medicine procedures, but there has always been that nagging fear of disease transmission,” Vangsness said. “Allograft ligament use continues to expand in knee surgery. The BioCleanse process eliminates the risk of allograft- associated disease transmission. It is the only method that is validated to sterilize bone and soft tissue allografts without damaging them. No other method can compare to the safety or proven science of the BioCleanse process.”
Regeneration Technologies, Inc.
CONTACT: Wendy Crites Wacker, APR, Corporate Communications,Regeneration Technologies, +1-386-418-8888
Web site: http://www.rtix.com/