ALACHUA, Fla., Aug. 3 /PRNewswire-FirstCall/ -- Regeneration Technologies, Inc. (RTI) , the Florida-based processor of orthopedic, cardiovascular and other biologic implants, announced today that the company has successfully implanted the first Sterling(R) Impacted Cortical Spacer as part of a clinical evaluation.
The surgery represents the first human implantation of RTI’s Sterling interbody device which combines RTI’s patented BioCleanse(R) Tissue Sterilization Process with xenograft tissue. The implant was used in a one- level anterior cervical fusion in July 2006 at the Department of Orthopedic Surgery, University Hospital of Bordeaux, France. This is the first implantation in a series of clinical evaluations with additional patient enrollment underway. RTI’s goal is to enroll an additional 24 patients with results available after a one-year post operative follow-up.
Sterling Biological Matrix provides surgeons an expanded supply of safe, sterile tissue that is a natural alternative to autograft, allograft, titanium and synthetic cages. RTI’s patented BioCleanse Tissue Sterilization Process enables delivery of xenograft implants that are sterile with improved biocompatibility and preserved structural integrity.
“This study is the first for a Sterling bone construct in the spine and it is our intent to publish data from this and other studies which are underway, to document the effectiveness of our Sterling product implants,” said Brian Hutchison, RTI’s Chairman, President and CEO. “The Sterling line, which was introduced in late 2005, continues to reinforce RTI’s commitment to enhancing the lives of patients by pioneering health solutions through regenerative medicine.”
In previous animal studies, the effects of BioCleanse on xenograft tissue were tested. Results of the RTI sponsored study showed that the BioCleanse treatment process renders bovine xenograft essentially equivalent to allograft in both biocompatibility and incorporation.
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 700,000 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 .
For more information, contact: Jenny Lynne Wills Corporate Communications Phone (386) 418-8888
Regeneration Technologies, Inc.
CONTACT: Jenny Lynne Wills, Corporate Communications, RegenerationTechnologies, +1-386-418-8888
Web site: http://www.rtix.com/