Timothy Daniels, MD Presents Results From Augment™ Injectable Bone Graft Clinical Trial
Slides from the presentation will be filed by the Company as an exhibit to a Form 8-K following the AOFAS meeting.
About Augment Injectable
Augment Injectable Bone Graft (AIBG) is being developed as an alternative to autograft in orthopedic surgery. In clinical studies, AIBG has been evaluated as a healing adjunct to fusion in hindfoot and ankle surgeries and distal radius fractures. The product is comprised of recombinant human platelet-derived growth factor and a tri-calcium phosphate and collagen carrier (rhPDGF-BB/β-TCP/collagen). At the point of use, the components are mixed and subsequently applied to the surgical site. The final consistency is a flowable paste, which can be extruded through a narrow gauge needle. AIBG is designed for controlled delivery to open surgical sites, to complement minimally invasive surgery or percutaneous delivery. It should be noted that the U.S. FDA has not approved the protocol used in the study reported here by Dr. Daniels, specifically the combining of the autograft patients from the previous Augment Bone Graft pivotal clinical trial. An additional study is currently ongoing in the U.S. and Canada which employs a 2:1 (AIBG:autograft) randomization schedule. The Company plans to utilize the historical autograft dataset as supporting documentation for future Augment Injectable regulatory filings.
About BioMimetic TherapeuticsBioMimetic Therapeutics (NASDAQ: 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 hindfoot 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 Augmatrix™ Biocomposite Bone Graft. For further information, contact Kearstin Patterson, senior director of corporate communications, at 615-236-4419.
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