Regeneration Technologies' Patented Process Named in Medical Journal as Solution to Tissue Sterilization


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.


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