Bacterin's Osteoselect DBM Putty Receives 510(k) Approval for Spinal Fusion

Bacterin International Holdings, Inc.

, a leader in the development of revolutionary bone graft material and coatings for medical applications, is pleased to announce it has obtained 510(k) approval to market OsteoSelect® DBM Putty for use in spinal fusion procedures. OsteoSelect® is a moldable bone graft substitute designed to withstand irrigation while exhibiting osteoinductive properties for improved bone regeneration. The cohesive nature of the product provides an advantage over other commercially available DBM putties which can readily wash away after placement in wet, surgical environments. As part of the regulatory approval process, Bacterin provided funding to Hospital for Special Surgery in New York to perform a study evaluating the efficacy of OsteoSelect® in a rabbit posterolateral lumbar spine fusion model. Biomechanical, radiographic, and histological analysis indicated that OsteoSelect® showed equivalence to a control of autologous iliac crest bone graft which is widely considered to be the gold standard for spinal fusion. "We are proud to obtain another indication for use that will provide Bacterin with additional marketing opportunities for the OsteoSelect® DBM Putty product line," said Gregory Juda, PhD, Bacterin's Chief Scientific Officer. Dr. Juda continued to say, "In the 3 plus years of OsteoSelect® being on the market, we have seen considerable adoption by the orthopedic community across a variety of surgical specialties. Our post market surveillance supports the efficacy of OsteoSelect® and the results of the preclinical work validate the clinical findings." OsteoSelect® DBM Putty is a malleable bone grafting material comprised of demineralized bone matrix allograft combined with a polymer carrier material. The product was engineered using feedback from key opinion leaders in several orthopedic specialties, with a focus on providing solutions to the shortcomings inherent to other commercially available DBM products. The osteoinductive potential of every lot of OsteoSelect® is confirmed after sterilization in an animal model thus providing surgeons with a bone grafting solution that is both safe and biologically active.