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Located in Franklin, Tennessee, BioMimetic (NASDAQ: BMTI) is a biotechnology company developing orthopedic surgical devices that deliver purified recombinant human platelet-derived growth factor (rhPDGF-BB) to promote tissue healing and regeneration. rhPDGF-BB is a synthetic form of PDGF, one of the body's principal agents to stimulate and direct healing and regeneration. The mechanism of action of PDGF suggests it may be effective in a broad array of musculoskeletal applications, including the repair of bone, ligament, tendon and cartilage. Through the commercialization of this technology, BioMimetic seeks to become the leading company in the field of orthopedic regenerative medicine.
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 deveoped into a successful drug product." — Harvard Focus (2005)
The Company's initial focus in orthopedics is the development of Augment™ Bone Graft (rhPDGF/Beta-TCP) as a substitute for autograft in foot and ankle fusions. Results of a 436 patient randomized controlled trial in the U.S. 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). The Company submitted its Pre-Marketing Approval (PMA) application to the FDA for the marketing of Augment in the U.S. in February of 2010. The Company previously received approval from Health Canada to begin marketing Augment as an alternative to the use of autograft in foot and ankle fusion indications in Canada.
The Company has also initiated a pivotal study in North America to assess the safety and efficacy of Augment Injectable™ Bone Graft as a substitute for autograft in foot and ankle fusion procedures. This randomized, controlled study is intended to support Augment Injectable product registration in the United States and Canada. The injectable formulation will allow delivery of the product to the fusion site through a syringe ensuring controlled and consistent delivery. Additionally, the Company plans to initiate a pilot trial in sports medicine applications by the end of 2010.
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 reinvested the proceeds in the development of products for the orthopedics and sports medicine markets.
Corporate Timeline
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