ALACHUA, Fla., June 1 /PRNewswire-FirstCall/ -- Regeneration Technologies, Inc. (RTI) (Nasdaq: RTIX - News), the Florida-based processor of orthopedic, cardiovascular and other biologic implants, announced today that the company has received its first CE marks for several Sterling® implants used in spinal, sports medicine and general orthopedic surgeries. These xenograft implants can now be distributed throughout Europe.
The implants receiving the CE mark are: Sterling Cancellous Chips, Sterling Cancellous Cubes, Sterling Suture Anchor, Sterling Interference Screw ST, Sterling Interference Screw HT, Sterling Impacted Cortical Wedge, Sterling Impacted Cortical Ring, Sterling SR, Sterling Machined Dowel and the Sterling HTO Wedge.
“Our plans to launch and grow our Sterling product line are advanced by these certifications,” said Brian K. Hutchison, RTI’s chairman, president and CEO. “We can now bring sterilized xenograft to surgeons internationally, supplementing the unmet demand for biological solutions in surgery. It is RTI’s goal to lead the biologics evolution in health care, and we remain committed to enhancing the lives of patients by pioneering health solutions through regenerative medicine.”
The Sterling Biological Matrix provides surgeons an expanded supply of safe, sterile tissue that is a natural alternative to autograft, allograft and synthetic resorbable materials. Studies show that Sterling grafts maintain structural integrity and biocompatibility.
Meeting International Regulatory Requirements
To receive these certifications, the Sterling implants were first assessed under the European Medical Device Directive 93/42/EEC Annex II Section 4. Additionally, the implants were required to satisfy TSE Directive 2003/32/EC, a more stringent standard that requires both proof of product safety and demonstration of a clinical need for the product.
RTI was able to prove safety of the Sterling bovine line through its longstanding, exclusive agreement with a USDA-certified, BSE-free closed and organic herd. The self-sustaining agricultural operation has been certified closed by the USDA since 1992 with no animal-derived protein used in the feed since the inception of the herd. The United States Department of Agriculture has issued a Health/Export Certificate that certifies the Sterling bovine implants used “have been produced under a system designed to ensure that they are free from (unlikely to transmit) disease agents, including transmissible spongiform encephalopathies (TSEs).”
RTI’s Sterling implants also offer the benefits of RTI’s patented BioCleanse® 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 implants function as a natural biologic scaffold, allowing for rapid 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.
International Market Impact of Sterling Line
The addition of Sterling implants to RTI’s international distribution allows the company to further tap into a $369.5 million international biologics market. The Sterling implants with the CE mark are available through RTI’s international distribution partners.
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 675,000 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 http://www.rtix.com or the SEC’s web site at http://www.sec.gov .
Source: Regeneration Technologies, Inc.
