Tennessee-based BioMimetic Therapeutics, a biotechnology company specialising in the development and commercialisation of innovative regenerative drug-device combination products for musculoskeletal injuries and diseases, has announced that the US FDA has tentatively scheduled an Orthopedic and Rehabilitation Devices Panel meeting on 12 May 2011 to review its Premarket Approval (PMA) application for Augment Bone Graft.
BioMimetic Therapeutics president and CEO Samuel Lynch said that with the date set for the FDA advisory panel meeting, it would give the company to present its findings from the Augment clinical programme. About 650 patients have been treated with its graft in the clinical trials in the last four years.
"Moreover, GEM 21S, a nearly identical product, has proven safe and effective for treatment of periodontal bone and soft tissue defects during its five years of commercial use," Lynch said.
"If approved, Augment will be the first new recombinant bone and tissue growth factor technology to be introduced for orthopedic uses in nearly a decade."
Augment may also become a therapeutic option to treat foot and ankle fusions without the pain and morbidity associated with the current gold standard that requires taking autogenous bone from elsewhere in the patient’s body, once approved, Lynch added.