FDA has accepted for review BioMimetic Therapeutics' premarket approval (PMA) application of Augment Bone Graft for use in foot and ankle fusions. The FDA has filed the application and begun the comprehensive review of the clinical module.
BioMimetic said that, following the submission of its PMA in February, the FDA has requested 12 month safety data for at least 85% of the Augment North American pivotal study patients in addition to the requirements previously set forth and agreed upon in the investigational device exemption (IDE).
In response to the request, the company had submitted 12 month data on 100% of the patient safety population to the FDA, which demonstrate no new product related serious adverse events or any other safety concern.
According to BioMimetic, the FDA has officially accepted the application and the company anticipates receiving additional feedback from the Agency in the third quarter, with an advisory panel review late this year or early 2011.
Samuel Lynch, president and CEO of BioMimetic Therapeutics, said: “Receipt of the PMA filing letter from the FDA is an important step in the process for approval of Augment Bone Graft in the US.
“We expect to have the 100-day meeting with the FDA in the third quarter, at which time we will get more detailed feedback and questions from the Agency related to the PMA application. We hope at that time to be able to agree with the Agency on a date for an advisory panel meeting for review of Augment.”