Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

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

You may also be interested in...



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

Related Content

Topics

UsernamePublicRestriction

Register

MT028871

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel