BMTI BioMimetic Therapeutics, Inc. Receives Approval to Commercialize Augment(R) Bone Graft in Australia
FRANKLIN, Tenn., Oct 19, 2011 (BUSINESS WIRE) -- BioMimetic Therapeutics, Inc. BMTI +18.00% today announced that the Therapeutic Goods Administration (TGA) has approved the Company's medical device application for Augment(R) Bone Graft clearing the way for commercialization of the product in Australia and its listing on the Australian Register of Therapeutic Goods (ARTG). Based on the clinical data from the North American pivotal trial and Canadian registration trial evaluating Augment Bone Graft, the product has been approved in Australia for use as an alternative to autograft, the current gold standard in bone grafting, in hindfoot and ankle fusion procedures.
"Approval of Augment Bone Graft by another major regulatory agency, such as the TGA, marks a significant achievement in BioMimetic's global product development program and further validates our technology, clinical data and ability to gain regulatory approvals," said Dr. Samuel Lynch, president and CEO of BioMimetic Therapeutics. "Given that obtaining autograft often requires a second surgical procedure, increasing the pain and potential for complications for the patient, and that Augment will be the first alternative approved in foot and ankle fusion surgery with large, randomized controlled clinical data, we are optimistic that Augment will find broad support from Australian hospitals, surgeons and patients alike. We are completing the final steps for pricing and reimbursement and expect a full launch of the product in the first quarter of 2012."
