BioMimetic Augment PMA Delayed Slightly As FDA Seeks Additional Data
This article was originally published in The Gray Sheet
Executive Summary
FDA approval of BioMimetic Therapeutics' Augment synthetic bone graft will likely be delayed by several months after the agency recently requested 12-month follow-up data, the firm said
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BioMimetic's Augment Bone Graft Goes To Panel In May
FDA's Orthopedic and Rehabilitation Devices panel will meet May 12 to discuss a pre-market approval application for BioMimetic Therapeutics’ Augment fully synthetic bone graft, the firm announced Jan. 31.
BioMimetic's Augment Bone Graft Goes To Panel In May
FDA's Orthopedic and Rehabilitation Devices panel will meet May 12 to discuss a pre-market approval application for BioMimetic Therapeutics’ Augment fully synthetic bone graft, the firm announced Jan. 31.
BioMimetic Therapeutics' Augment
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