As of March 1, 2013, BioMimetic Therapeutics, Inc. is now part of Wright Medical Group, Inc.
Please click here
for Wright Medical investor information.
Located in Franklin, Tennessee, BioMimetic Therapeutics, LLC. specializes in the development and commercialization of products to promote the healing of musculoskeletal injuries and diseases, including therapies for orthopedic and sports medicine applications. All Augment branded products are based upon recombinant human platelet-derived growth factor (rhPDGF-BB), which is a bioengineered form of PDGF, one of the body's principal agents to stimulate and direct healing and regeneration. Through the commercialization of this patented technology, BioMimetic seeks to become the leading company in the field of regenerative medicine by providing new treatment options for the repair of bone, cartilage, tendons and ligaments.
Dr. Samuel Lynch, BioMimetic's founder, conducted research on the role of PDGF in tissue repair and regeneration while on staff at Harvard beginning in the mid 1980s. 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)
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. In May 2011, the FDA’s Orthopedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee voted favorably on Augment® Bone Graft’s safety, efficacy and benefit to risk profile for its use as an alternative to autograft in hindfoot and ankle fusions, and the product is pending a final FDA regulatory decision. Augment® Bone Graft is available for sale as an alternative to autograft in foot and ankle fusion indications in Canada, Australia and New Zealand.
The Company closed enrollment in a pivotal study in Canada to assess the safety and efficacy of Augment® Injectable Bone Graft as a substitute for autograft in foot and ankle fusion procedures and has enrolled 105 patients in a North American pivotal study with the same product in hindfoot fusion indications.
In early 2013, BioMimetic initiated enrollment in a Phase II clinical trial to assess the safety and efficacy of Augment® Chronic Tendinopathy as a treatment for lateral epicondylitis, commonly known as tennis elbow. The randomized, controlled trial is expected to enroll up to 100 patients at seven clinical sites in the U.S. and will evaluate the safety and therapeutic potential of escalating doses of a one-time injection of rhPDGF-BB solution into the extensor carpi radialis brevis (ECRB), the tendon in the elbow that is generally the source of pain in tennis elbow. The product candidate is aimed at the tendinopathy market for which there is significant unmet clinical need with few effective long-term treatments currently available.
Further, BioMimetic completed a pilot clinical trial In Canada to assess the safety and clinical utility of Augment® Rotator Cuff Graft for the repair of large rotator cuff tears and released data from the study in early 2012. The Company continues to evaluate rhPDGF-BB as a therapeutic for additional sports medicine and spine surgery applications and has released positive pre-clinical data in these areas.
The Company also markets a bone graft substitute line of products for orthopedic indications called Augmatrix™ Biocomposite Bone Graft. The products are available in multiple forms to suit an array of bone grafting challenges, including fracture repair and general bone void filling procedures. The products are available for sale in the U.S.
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 is approved for marketing in the United States and Canada based on the results of a successful, randomized, controlled clinical trial to establish product safety and efficacy. BioMimetic became one of the first companies to successfully develop and commercialize a recombinant (synthetic) protein therapeutic for bone and tissue regeneration in the U.S. 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 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, and the make-up of GEM 21S® is nearly identical to the Company's lead orthopedic product candidate, Augment Bone Graft. 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.
[ click to enlarge ]
*GEM 21S is a trademark of Luitpold Pharmaceuticals, Inc., who markets this product through its Osteohealth division in the United States and Canada.