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Product also reduces supply costs compared with Medtronic's Infuse, study concludes.
February 27, 2014
By: Michael Barbella
Managing Editor
In the first head to head, peer reviewed, published study, patients undergoing lateral/transforaminal lumbar interbody fusion procedures with Advanced Biologics’ OsteoAMP showed higher fusion rates and reduced supply costs compared with patients undergoing the same procedures with rhBMP-2 (Infuse, Medtronic Inc). The study of 321 patients at three centers was published in The Journal of Orthopaedic Surgery and Research. Radiologic review and evaluation, assessed at various time points, was conducted by an independent radiologist blinded to intervention, product and surgeon information. The analysis indicated fusion rates for the OsteoAMP patients displayed statistically significant superiority over rhBMP-2 patients at 6, 12, and 18 months (p<0.01). In addition, OsteoAMP provided cost savings as it was approximately 74 percent less expensive per level and per patient than rhBMP-2. “OsteoAMP has been a part of my practice since 2009 and has become my primary osteobiologic,” said Jeffery Roh, M.D., lead author of the study. “My patients complain less of radiculitis and feel better faster. Using OsteoAMP has reduced my worry of long-term consequences when using rhBMP-2.” Amit Govil, President of Advanced Biologics, said, “As a company, our aim is to provide a product that’s value to surgeon, hospital and patient is based on sound clinical analysis, rather than irrelevant testing models that are the norm in the industry. Rather than attempt to substantiate our technologies via basic animal studies or clinical data with undersized patient populations, we have continued to expand our data set for OsteoAMP, further validating its efficacy.” Advanced Biologics LLC currently is finalizing clinical sites for a new study titled, “A Prospective, Randomized Study of Instrumented, Posterolateral Spinal Fusions with OsteoAMP versus Autograft.” The study has established Rush University Medical Center and West Virginia University as multiple principal investigators. Founded in 2009, Advanced Biologics (ABC) is a privately-held developer of biologic solutions. Its OsteoAMP family of osteoinductive/conductive products is the first line of orthobiologic offerings. The company is headquartered in Carlsbad, Calif.
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