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.
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.
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.
The company also plans to seek European approval during the first half of 2012.