RTI Biologics Inc. (RTI) (Nasdaq: RTIX), the Florida-based processor of orthopedic, dental, surgical specialties and other biologic implants, is launching a new biologic implant for use in sports medicine, orthopedic and spine surgeries. BioReady™ DBM Putty and Putty with Chips is a ready-to-use, 100 percent allograft DBM solution. BioReady DBM Putty is an extension of RTI Biologics’ DBM portfolio which includes BioSet™ DBM Paste and BioAdapt™ Foam. BioReady DBM Putty is a ready-to-use demineralized bone matrix (DBM) implant that provides convenience, robust handling, verified osteoinductive* potential and sterility. It was introduced at the RTI Biologics exhibit at the North American Spine Society (NASS) annual meeting in Dallas this week. BioReady DBM Putty and Putty with Chips are 100 percent allograft, and each donor lot is tested for osteoinductive potential. Data shows that BioReady DBM Putty retains its osteoinductive potential throughout its entire shelf life. This ready-to-use implant does not require any preparation, such as thawing or mixing, and it is available in various sizes for use as a bone void filler in many types of surgical procedures. “BioReady is an exciting allograft solution that complements our portfolio of DBM implants including BioSet and BioAdapt,” said Roger Rose, executive vice president and chief commercial officer for RTI Biologics. “This ready-to-use implant addresses a significant clinical need and ensures that we maximize every gift of donation received.” RTI’s implants are sterilized through processes validated by tissue type. BioReady DBM Putty is sterilized through the Cancelle™ SP Demineralization Process. Through a combination of oxidative treatments and acid or alcohol washes, cellular debris is removed and pathogens are inactivated. Cleansing rinses remove residual chemicals, maintaining biocompatibility, and terminal low temperature, low dose gamma irradiation achieves device-level sterility, preserving the utility of the graft. BioReady DBM Putty is currently available for distribution. For further information, contact an RTI representative at (800) 624-7238.
*DBM or representative finished implant is either assayed in vivo in the modified athymic nude rat for bone formation or in vitro for endogenous BMP-2 as a surrogate test marker for osteoinductive potential. Because the combination of various proteins is responsible for osteoinductive potential, DBM when assayed in vitro, is also screened for the presence of BMP-7. Findings from an in vitro assay or animal model are not necessarily predictive of human clinical results.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 and using proprietary 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. The BioCleanse® Tissue Sterilization Process, the Tutoplast® Tissue Sterilization Process and the Cancelle™ SP Demineralization Process 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.