RTI Biologics ® Announces Milestone in Tissue Processing: More than 5 Million Implants Sterilized with Zero Incidence of Implant-Associated Infection
ALACHUA, Fla.--(BUSINESS WIRE)-- RTI Biologics Inc. (RTI) (NAS: RTIX) , a leading provider of orthopedic and other biologic implants, is pleased to announce that the company has passed the five million mark in distributing implants sterilized through its patented, validated tissue sterilization processes, BioCleanse®, Tutoplast® and Cancelle® SP, with zero incidence of implant-associated infection.
"Standard methods of preparing tissue for transplantation simply do not do enough to protect patients from the risk of disease transmission," said Brian K. Hutchison, RTI president and chief executive officer. "Surgeons have many options when it comes to life-restoring biologics, and our redundant safeguards provide the highest level of confidence that patients will receive safe tissue."
RTI owns the intellectual property rights for the BioCleanse Tissue Sterilization Process, Tutoplast Tissue Sterilization Process and Cancelle SP DBM Sterilization Process which are each validated by tissue type to penetrate tissue, inactivate viruses and remove organisms using worst-case testing while retaining biocompatibility and tissue function.
The patented BioCleanse Tissue Sterilization Process is an automated, pharmaceutical grade process that sterilizes tissue using a complex, proprietary combination of mechanical and chemical processes. The BioCleanse process, in use since March 2000, does not use excessive heat or irradiation when sterilizing tissue. BioCleanse is used on implants that provide a natural biologic scaffold in orthopedic, spine and sports medicine.
The Tutoplast Tissue Sterilization process, with a more than 40 year history, is a chemical sterilization methodology originally developed by Tutogen Medical, GmbH in Neunkirchen, Germany, which merged with RTI in February 2008. The process sterilizes and preserves membrane and soft tissue augmentation grafts, as well as bone particulate tissue for use in dental, urological and other procedures.
The Cancelle SP DBM Sterilization Process is a proprietary process that sterilizes demineralized bone matrix (DBM) pastes and putties while preserving protein activity. In their final form, DBM implants serve as bone void fillers in many applications, including spinal, general orthopedic, joint reconstruction and dental surgeries.
"We have always held ourselves to a higher standard because of the importance of the work we do for the medical community and on behalf of the donation community," said Hutchison. "Surgeons and patients depend on their tissue processor to provide implants that are biomechanically equivalent and safe. The science behind our processes allows us to do just that."
About RTI Biologics Inc.
RTI Biologics Inc. is a leading provider of sterile biologic implants for surgeries around the world with a commitment to advancing science, safety and innovation. RTI prepares human donated tissue and animal tissue for transplantation through extensive testing and screening, precision shaping and using proprietary, validated processes. These allograft and xenograft implants are used in orthopedic, dental 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 validated sterilization processes that include viral inactivation steps. These processes — BioCleanse®, Tutoplast® and Cancelle® SP DBM — have a combined record of more than four million implants distributed with zero incidence of implant-associated infection. These processes have been validated by tissue type to inactivate or remove viruses, bacteria, fungi and spores from the tissue while maintaining biocompatibility and functionality.
RTI's worldwide corporate headquarters are located in Alachua, Fla., with international locations in Germany and France. The company is accredited by the American Association of Tissue Banks in the United States and is a member of AdvaMed.
RTI Biologics Inc.
Jenny Highlander, APR, 386-418-8888
Manager, Corporate Communications
KEYWORDS: United States Europe North America Florida Germany
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