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Located in Franklin, Tennessee, is a biotech company utilizing recombinant human platelet-derived growth factor (rhPDGF-BB) as its primary technolog platform. This molecule is a synthetic copy of one of the body's principal agents to stimulate and direct healing and regeneration. PDGF stimulates cells of musculoskeletal origin, therefore, protein therapeutics with rhPDGF-BB have significant potential to treat injuries and conditions affecting bone, tendon, ligament and cartilage. Through the commercialization of this technology, BioMimetic seeks to become the premier orthobiologics company in orthopedics.
While on staff at Harvard beginning in the mid 1980s, Dr. Samuel Lynch, BioMimetic's president, CEO and founder, conducted research on the role of PDGF in tissue repair and regeneration. These efforts generated a foundation of scientific knowledge and intellectual property from which BioMimetic Therapeutics is now based.
"This appears to be the first discovery in a Harvard medical or dental lab to be commercialized by one of its inventors and developed into a successful drug product." — Harvard Focus (2005)
From inception to 2005, BioMimetic was primarily focused on the development of therapeutics to treat bone loss as the result of severe periodontal disease. During this period, the Company developed GEM 21S® (rhPDGF-BB/β-TCP) for this clinical indication. The product was approved for marketing in the United States and Canada in 2005 and 2006, respectively, on the basis of a successful, randomized, controlled clinical trial to establish product safety and efficacy. As a result of the PMA approval, BioMimetic became one of the first companies to successfully develop and commercialize a recombinant (synthetic) protein therapeutic for bone and tissue regeneration. The development of this product demonstrated BioMimetic’s capability to conduct large-scale clinical trials, create a manufacturing supply chain and navigate the regulatory environment (FDA and Health Canada) required to obtain product approvals. Further, the clinical results and market approval of GEM 21S® validated rhPDGF-BB as a potent stimulus for the regeneration of bone.
In 2008, BioMimetic sold the rights to GEM 21S® and remaining interest in the orofacial business and reinvest the proceeds in the development of products for the orthopedics and sports medicine markets. The Company's initial focus in orthopedics is the development of Augment (rhPDGF/Beta-TCP) as a substitute for autograft in foot and ankle fusions. Results of a 436 patient randomized controlled trial comparing Augment to autograft were released in October 2009. For the pre-specified primary endpoint, patients treated with Augment experienced a similar fusion rate (61.2%) compared with those receiving autograft (62.0%). These data met statistical non-inferiority (p=0.037; n=397 patients).
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