, Inc. (NASDAQ: BMTI) today announced that the Therapeutic Goods Administration (TGA) has approved the Company’s medical device application for Augment
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.
, president and CEO of
. “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.”
Augment Bone Graft
Augment was approved in Canada in November 2009 as an alternative to the use of autograft in midfoot, hindfoot and ankle fusion indications and approvability decisions are currently pending in the United States and European Union. Augment is a completely synthetic two-component grafting system for bone regeneration and is composed of a purified bone and tissue growth factor, recombinant human platelet derived growth factor (rhPDGF-BB), and a synthetic calcium phosphate matrix, beta-tricalcium phosphate (β-TCP). When combined the rhPDGF-BB provides the biological stimulus for tissue repair by stimulating the recruitment and proliferation of new bone forming and wound healing cells and blood vessels, while the β-TCP provides the framework or scaffold for new bone growth to occur. Clinicians are referred to the Augment package insert for additional information on the use of this product.