FDAnews
www.fdanews.com/articles/161396-postmarket-data-shows-advanced-biologics-osteoamp-superior-to-rhbmp-2

Postmarket Data Shows Advanced Biologics’ OsteoAMP Superior to rhBMP-2

January 1, 2014

A postmarket study published in the Dec. 28 Journal of Orthopaedic Surgery and Research finds Advanced Biologics’ OsteoAMP provides statistically significant improvement in bone fusion rates and lowers costs by about 74 percent compared with rhBMP-2, a recombinant human protein used to promote new bone grown.

The study was based on an independent review of 321 patients at three centers at one three, six, 12 and 18 months post lateral lumbar interbody fusion or transforaminal lumbar interbody fusion surgery. OsteoAMP yielded higher rates of fusion at six, 12 and 18 months than rhBMP-2 and achieved fusion in 40 percent less time. Patients who used OsteoAMP also had 70 percent fewer complications, the study says.

Derived from cadavers, OsteoAMP binds angiogenic, mitogenic and osteoinductive growth factors in bone marrow cells to allograft. The product comes in four different forms — granules, putty, structural forms and a compressible sponge — each of which provides slightly different advantages, according to Advanced Biologics. The sponge, for example, is useful in fusing irregularly shaped anatomical areas.

Company spokesman Scott Cadotte said OsteoAMP acts as a scaffold for bone growth, while providing growth factors that form a chemical signal that induces bone formation. Advanced Biologics has marketed OsteoAMP in the U.S. since 2009 and plans to launch it internationally this year. — Lena Freund

Subscribe to Devices & Diagnostics Letter for complete coverage of the medical devices industry. Click here for more information.