Jun 29 2010
BioMimetic Therapeutics, Inc. (NASDAQ: BMTI) today announced the Food & Drug Administration (FDA) has accepted for review its Premarket Approval (PMA) application for Augment™ Bone Graft for use in foot and ankle fusions in the U.S. The FDA has now filed the application and begun the comprehensive review of the clinical module.
“Receipt of the PMA filing letter from the FDA is an important step in the process for approval of Augment Bone Graft in the U.S.”
Following the Company's submission of its PMA in February, the FDA 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 that request, in early May, the Company submitted to the FDA 12 month data on 100% of the patient safety population, which demonstrate no new product related serious adverse events or any other safety concern.
Now that the FDA has officially accepted the application, the Company anticipates receiving additional feedback from the Agency in the third quarter, with an advisory panel review late this year or early 2011.
"Receipt of the PMA filing letter from the FDA is an important step in the process for approval of Augment Bone Graft in the U.S.," said Dr. Samuel Lynch, president and CEO of BioMimetic Therapeutics. "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."
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