FDA to Review Premarket Approval Application for BioMimetic Therapeutics' Augment Bone GraftWritten by Lindsey Dunn | June 29, 2010
BioMimetic Therapeutics has announced the Food & Drug Administration has accepted for review its Premarket Approval application for Augment Bone Graft for use in foot and ankle fusions in the United States, according to BioMimetic news release.
BioMimetic submitted the PMA in February, and the FDA requested 12 month safety data for at least 85 percent of the Augment North American pivotal study patients in addition to the requirements previously set forth and agreed upon in the Investigational Device Exemption. In May, BioMimetic submitted 12 month data for 100 percent of the study's patients. The data demonstrates no serious adverse events or any other safety concerns related to the new product, according to the release.
Now that the FDA has officially accepted the application, BioMimetic anticipates receiving additional feedback from the FDA in the third quarter, with an advisory panel review late this year or early 2011.
Read the BioMimetic release on the Augment Bone Graft.
Read other Becker's coverage on BioMimetic.
BioMimetic Updates Clinical Trial of Augment Bone Graft
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