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BioMimetic Therapeutics' Augment

This article was originally published in The Gray Sheet

Executive Summary

Synthetic bone graft PMA is on track for review by FDA's Orthopedic and Rehabilitation Devices Panel by early 2011, and approval in mid-2011, according to the company. BioMimetic announced Sept. 8 that a recent meeting with FDA on its PMA, which was filed by the agency in May, raised no "unexpected issues that would impact the timing" for the panel review (1"The Gray Sheet" July 19, 2010). The firm simultaneously announced that its Augment Injectable Bone Graft will also be regulated as a device following a recent Request for Designation submission. BioMimetic says it aims to start a U.S. trial for the injectable formulation of Augment in the fourth quarter, pending investigational device exemption clearance

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