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BioMimetic Therapeutics' Augment

This article was originally published in The Gray Sheet

Executive Summary

Synthetic bone graft PMA review is under way at FDA now that the agency has officially filed the submission, the company reports June 28. After BioMimetic submitted the PMA in February, FDA requested 12-month safety data for at least 85% of the North American pivotal study patients. In response, the firm submitted 12-month safety data on 100% of the patients in early May (1"The Gray Sheet" May 17, 2010). The data "demonstrate no new product-related serious adverse events or any other safety concern," according to the company. Augment, which is composed of recombinant human platelet-derived growth factor BB and beta-tricalcium phosphate granules, is intended as an alternative to autograft in foot and ankle fusion procedures. BioMimetic says it expects the PMA to receive an FDA advisory panel review in late 2010 or early 2011
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