Australia’s Therapeutic Goods Administration has approved BioMimetic Therapeutics’ Augment bone graft for marketing and listing on the Australian Register of Therapeutic Goods.
Augment is a completely synthetic two-component grafting system for bone regeneration.
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It is composed of a purified bone and tissue growth factor, recombinant human platelet-derived growth factor and beta-tricalcium phosphate, a synthetic calcium-phosphate matrix.
Recombinant human platelet-derived growth factor 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 beta-tricalcium phosphate provides the scaffold for new bone growth to occur.
The approval is backed by the clinical data from a North American pivotal trial and Canadian registration trial.
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BioMimetic Therapeutics president and CEO Samuel Lynch said that the company is finalising pricing and reimbursement, and expects to fully launch the product in the first quarter of 2012.
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By GlobalDataThe company also plans to seek European approval during the first half of 2012.
