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ALACHUA, Fla. -- Regeneration Technologies, Inc., 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 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, MD, 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."
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.
Source: Regeneration Technologies, Inc.