ALACHUA, Fla. -- Regeneration Technologies Inc. (RTI), the Florida-based processor of orthopedic, cardiovascular and other
allograft implants, announced today that musculoskeletal soft tissue sterilized
through the BioCleanse Tissue Sterilization Process is now available through
its exclusive sports medicine distributor, Stryker Endoscopy.
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.
The process was implemented in March 2000 for specialty shaped structural
allografts, and to date the company has distributed about 500,000 implants
sterilized with the BioCleanse process with zero incidence of infection.
An article in the June 17, 2004 issue of The New England Journal of Medicine
outlines a study done by the Centers of Disease Control and Prevention, which
concludes, "Sterilization methods that do not adversely affect the functioning
of transplanted tissue are needed to prevent allograft infections." The article
goes on to mention:
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(CDC: unpublished data).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associated with reports of allograft-associated infections (CDC: unpublished
"The recent infections have certainly raised my heightened concern over disease
transmission," said Dr. Peter Indelicato, professor of orthopaedics, director
of sports medicine and head team physician for University of Florida. "I think
BioCleanse will affect the future of orthopedic surgery, particularly in the
area of sports medicine, due to the fact that the concern over disease
transmission will be eliminated."
RTI's sports medicine implants are distributed domestically by Stryker
Endoscopy. The sports medicine line primarily includes tendon and ligament
allografts, offering the ultimate convenience in ACL and other joint repair.
Each year, there are about 4.3 million sports-related injuries in the United
States. More than 360,000 ACL procedures are done each year in the U.S., about
25 percent of which use allografts.
"We developed BioCleanse with the mind set that allograft implants should be a
zero-risk proposition," said Brian K. Hutchison, chairman, president and CEO of
RTI. "The introduction of BioCleanse for musculoskeletal soft tissue implants
raises the bar for safety standards in the use of biologics in orthopedic
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. The company is accredited by the American Association of
Tissue Banks and was named a 2004 Technology Pioneer by the World Economic
Forum for its leading innovations.