CARLSBAD, Calif., Aug. 13, 2014 /PRNewswire/ -- Advanced Biologics announced today the acceptance for publication of a new OsteoAMP study to be published in the Journal of Spine. In the study titled, Clinical Validation of Allogeneic Morphogenetic Protein: Donor Intervariability, Terminal Irradiation and Age of Product is not Clinically Relevant, an analysis was completed looking at the effects of different variables between allograft donors that were used to process OsteoAMP which was subsequently implanted in patients undergoing spinal fusion procedures.
This retrospective analysis of radiographic results compared fusion outcomes of 285 consecutive cervical and lumbar spinal fusion patients utilizing OsteoAMP growth factor bone grafts processed from 114 donors of varying ages. Fusion rates, evaluated via a blinded radiological fusion assessment, of the 285 patients were greater than 98% at 12 months.
“Donor intervariability has always been a concern among surgeons when using allograft-derived products,” said Amit Govil, president of Advanced Biologics. “Whether it is stem cell products or commodity DBMs, surgeons consistently mention to us their lack of confidence when rodent or in vitro testing is used for osteoinductivity yet it doesn’t transfer to clinical efficacy. Our study confirms that time to fusion in OsteoAMP patients has no correlation to the age of the allograft donor, the age of the product, or if the product has been terminally sterilized via low dose gamma irradiation.”
OsteoAMP® is an award winning allograft-derived growth factor that is a lower-cost alternative to recombinant growth factors, such as rhBMP-2 (Infuse®, Medtronic) and allograft-derived stem cells, such as Osteocel® Plus (Nuvasive) or Trinity® Elite (Orthofix). OsteoAMP®'s four distinctive formats (granules, compressible sponges, putty, and structural grafts) provide a distinct advantage by allowing surgeons to tailor deliver the technology according to their needs in surgery.
About Advanced Biologics
Founded in 2009, Advanced Biologics (ABC) is a privately-held company focused on developing innovative and clinically relevant biologic solutions across a wide degree of medical specialties. The OsteoAMP® family of osteoinductive/conductive products is the first line of orthobiologic offerings produced by ABC. ABC has been recognized three times as ‘Best New Technology’ during the Orthopedics This Week Spine Technology Awards.
SOURCE Advanced Biologics
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