Bone-grafting product Augment receives positive recommendation from FDA
Narrow vote follows committee's concerns over use of human platelet-derived growth factor.
Fri, May 13 2011 at 10:34 AM
Photo: Christopher Bailey/Flickr
A Food and Drug Administration (FDA) advisory committee has given a positive recommendation for Augment Bone Graft, a product from BioMimetic Therapeutics, Inc. developed to be used during foot and ankle surgeries, Dow Jones Newswires reports.
BioMimetic will now seek full FDA approval for its device.
Augment is intended to be an alternative to the traditional autograft procedures which harvests bone tissue from a patient's hip for use in the foot or ankle to reduce joint pain. The Augment process uses a combination of human platelet-derived growth factor to create bone-tissue regeneration and beta-tricalcium phosphate to form a porous scaffold for the new bone growth to occur.
The vote by the FDA's Orthopedic and Rehabilitation Devices Panel passed on a narrow margin. According to Dow Jones, "the panel voted 12-to-6 in the affirmative to the question of whether there was 'reasonable assurance' the product was safe, and voted 10-to-8 in the affirmative to another question about whether the product was effective."
Earlier this week, the panel indicated it had clinical concerns about Augment, posting a document which stated that it "still has concerns with the safety and overall risk/benefit of the device at this time, primarily due to the unanswered question of safety in regards to the potential for cancer formation versus and unproven benefit in the current standard for care." That document, and the impression it created that the FDA would vote against approving Augment, caused BioMimetic's stock price to drop by 34 percent on Tuesday, according to the Associated Press.
Previous studies link the use of a larger amount of the same growth factor to an increased rate of death in patients who had pre-existing cancers. The FDA reports BioMimetic is conducting further tests to see if the human growth factor has an impact on cancer growth.
In a prepared statement, Dr. Samuel Lynch, president and CEO of BioMimetic Therapeutics, said it was "gratifying to see the overwhelming support for the distribution of Augment in the market place and we expect to be ready to commercialize immediately upon approval from the FDA, which we expect within the coming six months."
Augment Bone Graft was approved for use in Canada in November 2009.