ALACHUA, Fla., Oct. 30 /PRNewswire-FirstCall/ -- Regeneration Technologies, Inc. (RTI) , the Florida-based processor of orthopedic, cardiovascular and other biologic implants, announces the first domestic implantations of the Sterling(R) Wedge, a member of the Sterling line of xenograft products.
Regeneration Technologies’ Sterling Biological Matrix wedge brings surgeons an expanded supply of safe, sterile tissue for filling bone voids and repairing fractures and skeletal defects in non-load-bearing indications. The wedge can be used in many of the 150,000 osteotomy procedures that are performed annually on the foot, ankle, leg, shoulder, hand and wrist.
“The Sterling Wedge offers structural and supply advantages,” said Dr. Jim Wang, implanting physician at the Santa Monica-University of California Los Angeles. “Where many human bone grafts can be brittle, the wedge is composed of dense cancellous bone with a cortical edge, which makes it easy to work with and allows surgeons to shape it precisely for each individual patient.”
RTI’s Sterling implants also offer the benefits of RTI’s patented BioCleanse(R) Tissue Sterilization Process, which enables delivery of sterile xenograft implants with improved biocompatibility and preserved structural integrity. In 2002, RTI sponsored an animal study which demonstrated that the BioCleanse process renders bovine xenograft essentially equivalent to allograft in both biocompatibility and incorporation.
Through the benefits of the BioCleanse process, the Sterling Wedge functions as a natural biologic scaffold, facilitating bone ingrowth into the implant and complete incorporation over time. The incorporation rate of BioCleanse-treated xenograft demonstrates the clinical benefit of using a sterilized biologic over a synthetic material, satisfying the clinical imperative requirement for the Sterling implants.
“The Sterling Biological Matrix uses bovine bone from a closed, organic herd and is subject to extremely strict quality controls - yet is a cost- effective alternative to cadaveric bone,” said Dr. Wang.
In order to accommodate various-sized defects, the wedge can be easily modified to shape and size using commonly available instruments. The wedge is offered in five different heights, ranging from 7.5 mm to 17.5 mm. The variety of sizes and the ability to customize the Sterling Wedge minimizes surgical procedure time, simplifies preoperative planning and reduces the labor intensive demands of traditional correction procedures. The Sterling line of implants is currently available through direct distribution force in the United States and through distribution partners internationally.
About Regeneration Technologies, Inc.
RTI processes allograft and xenograft tissue into shaped implants for use in orthopedic, cardiovascular and other surgeries with a commitment to science, safety and innovation.
RTI also 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 tissue. The company has distributed more than half a million allograft implants sterilized with the BioCleanse process with zero incidence of infection. 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, regulatory approvals or changes to the company’s agreements with its distributors 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 www.rtix.com or the SEC’s web site at www.sec.gov.
Regeneration Technologies, Inc.
CONTACT: Wendy Crites-Wacker, Corporate Communications, +1-386-418-8888,or Nancy Walsh, Marketing Communications, +1-386-418-8888, both ofRegeneration Technologies, Inc.
Web site: http://www.rtix.com//