The Company reported yesterday it has submitted to the Food and Drug Administration (FDA) an amendment to its Pre-Market Approval (PMA) application for Augment® Bone Graft for its use as an alternative to autograft in hindfoot and ankle fusion procedures.
About BioMimetic TherapeuticsBioMimetic Therapeutics (BMTI) is a biotechnology company specializing in the development and commercialization of clinically proven products to promote the healing of musculoskeletal injuries and diseases, including therapies for orthopedics, sports medicine and spine applications. All Augment® branded products are based upon recombinant human platelet-derived growth factor (rhPDGF-BB), which is an engineered 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.
BioMimetic has received regulatory approvals to market Augment® Bone Graft in Canada, Australia and New Zealand for use in foot and ankle fusion indications. Augment is pending regulatory decisions in the U.S. and European Union for similar indications. The Company also markets a bone graft substitute line of products for orthopedic indications called AugmatrixTM Biocomposite Bone Graft.
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