BioMimetic Therapeutics Ships Augment™ Bone Graft to Canadian Distributor; Product Now Available for Sale to Canadian Customers
Franklin, Tenn. – December 11, 2009 – BioMimetic Therapeutics, Inc. (NASDAQ: BMTI) announced today that the Company has shipped its first order of Augment Bone Graft to its Canadian distributor, Joint Solutions Alliance Corporation, a sales and distribution company for orthopedic products headquartered in Burlington, Ontario, Canada. Joint Solutions is the exclusive distributor of BioMimetic’s Augment Bone Graft product in Canada. BioMimetic will also utilize product specialists in the Canadian market to work collaboratively with the Joint Solutions Team. The product was recently approved by Health Canada for use as an alternative to autograft in foot and ankle fusion surgery. “Canada represents the first commercial opportunity within orthopedics for BioMimetic, so we are naturally very excited to have the product shipped and available for sale,” said Steven Hirsch, COO of BioMimetic Therapeutics. “Our distribution partner, Joint Solutions, has already begun the process of familiarizing orthopedic surgeons with Augment Bone Graft and the patient benefits of using Augment as an alternative to performing a second surgery to collect autograft. We are confident that once surgeons have evaluated the product, they will welcome the addition of this new regenerative technology to their surgical toolkit.”
Augment is a completely synthetic grafting system for bone regeneration and is composed of a purified recombinant growth factor, recombinant human platelet derived growth factor (rhPDGF-BB), and a synthetic calcium phosphate matrix, beta-tricalcium phosphate (β-TCP). The combination of the two components of Augment is the key to the overall effectiveness of the product. The rhPDGF-BB provides the biological stimulus for tissue repair by stimulating the recruitment and proliferation of new bone forming cells and blood vessels, while the β-TCP provides the framework or scaffold for new bone growth to occur. Autograft is the historical standard of care for these procedures but has the limitation that it must be obtained and transplanted from another bone in the patient’s body, often requiring a second surgical procedure. Previously released data shows, with the use of Augment, patients can expect a comparable treatment outcome while being spared the pain and potential morbidity associated with traditional autograft bone harvesting and transplantation.
BioMimetic Therapeutics is a biotechnology company utilizing purified recombinant human platelet-derived growth factor (rhPDGF-BB) in combination with tissue specific matrices as its primary technology platform for promotion of tissue healing and regeneration. rhPDGF-BB is a synthetic form of one of the body's principal agents to stimulate and direct healing and regeneration. The mechanism of action of this platform technology 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. BioMimetic received marketing approval from the FDA for its first product, GEM 21S®, as a grafting material for bone and periodontal indications. Additionally, BioMimetic Therapeutics has completed and ongoing clinical trials with its product candidates Augment and Augment Injectable in multiple orthopedic bone healing indications including the treatment of foot and ankle fusions and the stimulation of healing of fractures of the wrist. In November 2009, BioMimetic received approval from Health Canada to begin the marketing of Augment as an alternative to the use of autograft in foot and ankle fusion indications in Canada. GEM 21S is a trademark of Luitpold Pharmaceuticals, Inc., who now owns this dentally related product and markets it through its Osteohealth Company in the United States and Canada. For further information, visit www.biomimetics.com or contact Kearstin Patterson, corporate communications, at 615-236-4419. Forward-looking Statements This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on the current intent and expectations of the management of BioMimetic. These statements are not guarantees of future performance and involve risks and uncertainties that are difficult to predict. There are many important factors that could cause actual results to differ materially from those indicated in the forward-looking statements. BioMimetic’s actual results and the timing and outcome of events may differ materially from those expressed in or implied by the forward-looking statements because of risks associated with the marketing of BioMimetic’s product and product candidates, unproven preclinical and clinical development activities, regulatory oversight, and other risks detailed in BioMimetic’s filings with the Securities and Exchange Commission. Except as required by law, BioMimetic undertakes no responsibility for updating the information contained in this press release beyond the published date, whether as a result of new information, future events or otherwise, or for changes made to this document by wire services or Internet services. |
