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  • BioMimetic's pre-market approval application for Augment Bone Graft product on track 0 comments
    Sep 8, 2010 4:11 PM | about stocks: BMTI

    Biotech company BioMimetic Therapeutics (NASDAQ: BMTI) has completed its 100 day pre-market approval application (NYSEARCA:PMA) meeting with the FDA regarding the review of its Augment Bone Graft product for the treatment of foot and ankle fusions in the U.S., rendering the process on track.

    During its recent discussion with the company, the FDA raised no unexpected issues that would impact the timing for an upcoming Orthopedic Advisory Panel Meeting or potential approval of Augment, said the company.

    BioMimetic continues to anticipate that the panel meeting will be held by early 2011. If the panel determines the product to be safe, the company expects approval of Augment by the FDA in mid-2011.

    Separately, the drug company also announced that the FDA has completed the review of the its request for designation for Augment Injectable Bone Graft, the company's second generation bone grafting product.

    The Augment Injectable review will follow a medical device pathway and accordingly, has been assigned to the FDA's Center for Devices and Radiologic Health (CDRH) Division of Surgical, Orthopedic and Restorative Devices for lead review.

    Augment Injectable is being designed for easy, controlled delivery to open surgical sites, to complement minimally invasive surgery or to be used as a means to treat fractures and bone defects percutaneously.

    "We feel even more confident in the PMA we submitted for Augment earlier this year. Further, the Augment Injectable device designation provides a clear regulatory path for us to follow in the approval of this product candidate in the U.S. and keeps us on track with our clinical timeline," said president and CEO Dr. Samuel Lynch.

    Moreover, the company has expanded its patent portfolio in both the United States and Europe with the addition of two new patents, extending the company's protection for its products until 2026 and 2025, respectively.

    Both the U.S. and the European patents will cover the company's recombinant protein-device combination product candidates, including Augment Bone Graft and Augment Injectable Bone Graft, as well as GEMESIS, which the company previously sold to Luitpold Pharmaceuticals.

    BioMimetic Therapeutics uses purified recombinant human platelet-derived growth factor (rhPDGF-BB), a synthetic form of one of the body's agents that stimulates and directs healing and regeneration, in combination with tissue specific matrices, as its primary technology platform.

    The technology is effective in a broad array of musculoskeletal applications, including the repair of bone, ligament, tendon and cartilage.

    In November 2009, BioMimetic 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 was up nearly 8% since the release of the news to $9.87 as of 1:25pm ET on the Nasdaq on Wednesday.

    Disclosure: no position
    Stocks: BMTI
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