Bacterin Releases New Findings for OsteoSponge

Bacterin International Holdings Inc. recently presented the results of a study comparing its OsteoSponge product compared with recombinant human bone morphogenetic protein 2 or (rhBMP-2) used in spinal fusion. The study was conducted in collaboration with researchers at the Salt Lake Orthopaedic Clinic, Spine Surgery of Salt Lake City, Utah. The use of rhBMP-2 is for stiulating bone production.

Producting using rhBMP-2 recently have come under scrutiny.

“This risk of adverse events associated with rhBMP-2 is 10 to 50 times the original estimates reported in the industry-sponsored peer-reviewed publications,” according to Eugene Carragee, M.D., of Stanford University’s outpatient clinic in Redwood City, Calif., Carragee and colleagues wrote online in The Spine Journal, for which Carragee serves as editor in chief. Carragee references the Infuse bone growth product, which uses rhBMP-2 and is manufactured by Medtronic Inc.

Bacterin’s study findings were presented during the recent annual meeting of the American Academy of Orthopaedic Surgeons (AAOS) held Feb. 7-11 in San Francisco, Calif.

Initial study results were first presented at EuroSpine 2011 in Milan, Italy, in October of last year. The AAOS event was the first time the company had presented the data to a broad gathering of U.S. surgeons.

“AAOS is a great stage to get in front of orthopedic surgeons, who are the users of OsteoSponge,” said Guy Cook, Bacterin’s chairman and CEO. “Data from this study further validates OsteoSponge’s effectiveness in spinal fusion surgery, and we were pleased to present to and meet with a highly targeted audience.”

According to the firm’s leadership, since OsteoSponge was released during last year’s AAOS meeting in San Diego, Calif., surgeons have used Bacterin’s bone graft implants more than 100,000 times. The company claims that surgeon’s have noted the product’s “unique handling properties, ability to irrigate the site, and quick insertion” into a bony defect or a spinal interbody cage. Used in conjunction with the patients’ own bone marrow aspirate, OsteoSponge is an osteoconductive bone scaffold that aids in spinal fusion.

The two-year prospective, randomized, and blinded clinical data showed OsteoSponge to be equivalent to rhBMP-2 in achieving an interbody fusion based upon radiographic assessment, CT scans, and quality of life outcomes. Additionally, patients receiving the OsteoSponge graft reported statistically significant less leg pain at one year relative to the rhBMP-2 group.

The abstract of this presentation, which evaluated the effectiveness of Bacterin’s OsteoSponge allograft for use in lumbar spinal fusion and entitled, “Lumbar Interbody Fusion with OsteoSponge Demineralized Allograft in a PEEK Cage Compared to Fusion with rhBMP-2: Long Term Post-Operative Assessment,” was published in European Spine Journal (Volume 20, Supplement 4, 421-464).

Belgrade, Mont.-based Bacterin is a developer of anti-infective coatings for medical applications and bone graft material and biologic allografts for transplantation. The company’s biologic scaffolds, OsteoSponge, OsteoSponge SC and OsteoWrap, are made from demineralized bone that is malleable and flexible, to enable more efficient and precise handling, according to the company.