Advanced Biologics Validates OsteoAMP® Process Demonstrating No Clinically Relevant 'Donor to Donor' Variation
LADERA RANCH, Calif., Oct. 25, 2012 /PRNewswire/ -- Advanced Biologics announced today that is has validated the OsteoAMP process showing no clinically relevant 'donor to donor' variation. The OsteoAMP® validation used >100 consecutive allograft donors that were processed into products which resulted in 100% clinical success in >300 lumbar and cervical spine fusions. Clinical success was determined by fusion rates radiologically assessed via x-ray and CT by a blinded, independent radiologist.
The vast majority of allograft derived products utilize small animal or in vitro model(s) to validate their process and claim potential osteoinductivity. Even with these tests in place, a vast number of surgeons still call into question the potential variance across allograft donors. Through Advanced Biologics' proprietary process, allograft and its native bone marrow are processed and the BMPs and growth factors found within the bone marrow cells are extracted and bound to the allograft. This process results in an end product that has shown to contain 500-1000 times the BMP and growth factor amounts of any autograft or allograft derived biologic on the market.
"Advanced Biologics as a company aims to base its value on sound clinical analysis, rather than irrelevant testing models" stated President, Amit Govil. "We strive to rise above the 'smoke and mirrors' that has unfortunately become the norm in the osteobiologics industry. For this reason, we will not try to substantiate our technologies on animal studies or clinical data with undersized patient populations. We will continue to expand our data set for OsteoAMP® further validating its efficacy."
OsteoAMP® is an award-winning allogeneic growth factor that is a lower-cost alternative to recombinant growth factors, such as rhBMP-2 (Infuse®, Medtronic). Additionally, 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 was awarded the Best New Regenerative Technology award in 2009, Best New Biomaterial Technology Award in 2010, and 2011 Best New Technology in Biomaterials and Biologics by the Orthopedics This Week Spine Technology Awards. Future development includes a shape-memory, anti-bacterial synthetic product portfolio and ventures into other fields of regenerative medicine.
SOURCE Advanced Biologics, LLC
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