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Augment bone graft PMA

This article was originally published in The Gray Sheet

Executive Summary

Tissue healing and regeneration firm BioMimetic said it expects FDA to schedule an advisory panel later this year for Augment bone graft, following the firm's Feb. 17 submission of the third and final module of its PMA application for the synthetic graft. The module contains a comprehensive review of clinical data related to Augment, the firm states. The firm reported in October that Augment demonstrated noninferiority to autograft in hindfoot and ankle fusion surgery in the pivotal trial, but at least one investment analyst called the data "ambiguous" (1"The Gray Sheet" Oct. 19, 2009)

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