Regeneration Technologies Announces That Sterilized Soft Tissue Allografts Through Biocleanse are Now Available

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(CDC: unpublished data).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associated with reports of allograft-associated infections (CDC: unpublished

data).

"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

surgeries."

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.

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