RTI Biologics, Inc. (RTI) (Nasdaq:RTIX), the Florida-based processor of orthopedic, dental, hernia and other biologic implants, today announced the company is seeing expansion of its user base of RTI’s fresh-stored osteochondral (OC) allografts since its first implant in May. To date, more than 70 patients have received these biologic implants to repair cartilage damage, reducing their pain and returning them to more active lifestyles.
ALACHUA, Fla. (Business Wire EON) October 30, 2008 -- Ronald A. Navarro, M.D., chief of orthopaedic surgery for Kaiser Permanente South Bay Medical Center, performed surgery recently on a 22-year-old male patient using a fresh-stored right medial femoral hemi-condyle from RTI.
"These fresh grafts insure chondrocyte viability for the patient so that he can live with reconstituted anatomy for many years," said Navarro. "The patient was suffering for a couple of years before he underwent the operation and was encouraged by his dad, who had successfully undergone fresh osteochondral grafting by me several years before. As he is young and wants to continue an active lifestyle, fresh grafts with living chondrocytes provided the best opportunity for longevity of his knee."
Fresh-stored OC allografts provide mature hyaline cartilage with attached bone under the cartilage for repairing a joint surface, such as the knee. Hyaline cartilage is the specific type of cartilage that has poor healing and repair properties once damaged. When an injury occurs, a fresh-stored allograft with viable cartilage cells is needed for proper healing. The graft is cleansed, processed and preserved to provide a safe, high-quality allograft with a high level of chondrocyte viability, or live cartilage cells to enhance efficacy of the allograft implant.
RTI uses expedited release criteria to maintain fresh-stored graft utility. Like all RTI tissue, extensive donor screening in accordance with Food and Drug Administration (FDA) and American Association of Tissue Banks (AATB) requirements is conducted. In addition to serological testing, state of the art microbiological testing – which includes testing for bacterial spores and fungi – is used throughout the process to screen for potential contamination. Additionally, all fresh-stored OC allografts are placed in a proprietary antibiotic soak developed by RTI to eliminate potential contaminants.
Articles published in respected journals such as The American Journal of Sports Medicine and The Journal of Bone and Joint Surgery, have shown the efficacy of fresh osteochondral allografts in cartilage repair surgeries for many patients.
"We are happy to see the rapid adoption of RTI's fresh-stored OC allografts by sports medicine surgeons," said Rod Allen, RTI's vice president of sports medicine. "Fresh OC allografts and RTI's BioCleanse meniscus expand the clinical options that surgeons have to treat complex cartilage injuries."
In addition to fresh-stored grafts, RTI offers instrument sets. The instrument set facilitates harvesting of a large diameter osteochondral cylinder from the allograft as well as donor site preparation in order to achieve a press-fit on the patient repair site. The instruments are available for loan at no charge when combined with a fresh-stored grafted ordered from RTI.
Fresh-stored OC allografts are available through RTI's direct representatives and distributors. Anterior-posterior and lateral radiographs are used to size-match grafts to awaiting patients and are currently being accepted by RTI. For further information, contact an RTI allograft specialist at (800) 624-7238.
About RTI Biologics Inc.
RTI Biologics, Inc. is the leading provider of sterile biological implants for surgeries around the world with a commitment to advancing science, safety and innovation. RTI prepares human donated tissue and bovine tissue for transplantation through extensive testing and screening, precision shaping and proprietary, validated sterilization processes. These allograft and xenograft implants are used in orthopedic, dental, hernia and other specialty surgeries.
RTI's innovations continuously raise the bar of science and safety for biologics — from being the first company to offer precision-tooled bone implants and assembled technology to maximize each gift of donation, to inventing fully validated sterilization processes that include viral inactivation steps. Two such processes, the BioCleanse Tissue Sterilization Process and the Tutoplast process, sterilize tissue, are clinically successful and are scientifically proven to eliminate donor-to-recipient disease transmission risk while preserving tissue strength and biocompatibility. These processes have a proven record of more than two million implants distributed with zero incidence of infection. In addition, RTI pastes are sterilized through the demineralization process, a validated viral inactivation step.
The company is leading the evolution of biologics once again by offering a bovine based biological matrix, providing surgeons an expanded supply of safe, sterile tissue for their patients.
RTI's worldwide corporate headquarters are located in Alachua, Fla., with international facilities in Neunkirchen, Germany, and Aix-en-Provence, France. The company is accredited by the American Association of Tissue Banks.
Forward Looking Statement
This communication contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include but are not limited to statements about the expected benefits of the business combination involving RTI and Tutogen, including potential synergies and cost savings, future financial and operating results, and the combined company's plans and objectives. In addition, except for historical information, any statements made in this communication about anticipated financial results, growth rates, new product introductions, future operational improvements and results, regulatory approvals or changes to agreements with distributors also are forward-looking statements. Forward-looking statements are subject to risks and uncertainties, including the ability of RTI to integrate its business successfully and to realize the expected synergies and cost savings from the merger and the risks described in public filings on file with the Securities and Exchange Commission (SEC). 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.
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