08:00 , Nov 24, 2014 |  BC Week In Review  |  Clinical News

Augment Bone Graft regulatory update

FDA issued an approvable letter to Wright Medical for a PMA for Augment Bone Graft for use as an alternative to autograft in hindfoot and ankle fusion procedures. Wright said it needs to address inspection...
07:00 , Jul 16, 2012 |  BC Week In Review  |  Clinical News

Augment Bone Graft regulatory update

BioMimetic submitted to FDA an amendment to the PMA for Augment Bone Graft, which is under review for use as an alternative to autograft in hindfoot and ankle fusion procedures. In January, the agency asked...
08:00 , Jan 9, 2012 |  BC Week In Review  |  Clinical News

Augment Bone Graft regulatory update

BioMimetic said it received a response letter from FDA for a PMA for the company's Augment Bone Graft requesting additional information from a pivotal trial. The agency also requested further information related to postapproval studies...
07:00 , Oct 24, 2011 |  BC Week In Review  |  Clinical News

Augment Bone Graft regulatory update

BioMimetic said Australia's Therapeutic Goods Administration (TGA) approved its Augment Bone Graft for use as an alternative to autograft in hindfoot and ankle fusion. Augment is approved in Canada and under review in the U.S....
07:00 , May 16, 2011 |  BC Week In Review  |  Clinical News

Augment Bone Graft regulatory update

FDA's Orthopedic and Rehabilitation Devices Panel voted 10-8 that the benefits of BioMimetic's Augment Bone Graft to treat foot and ankle fractures outweighed its risks as an alternative to autograft. The panel also voted 12-6...
07:00 , Apr 4, 2011 |  BC Week In Review  |  Clinical News

Augment Bone Graft regulatory update

BioMimetic said FDA confirmed a meeting of the Orthopedic and Rehabilitation Devices Panel on May 12 to discuss its PMA for Augment Bone Graft to treat foot and ankle fractures. BioMimetic expects a decision on...
08:00 , Feb 7, 2011 |  BC Week In Review  |  Clinical News

Augment Bone Graft regulatory update

BioMimetic said the FDA tentatively scheduled a meeting of the Orthopedic and Rehabilitation Devices Panel on May 12 to discuss its PMA for Augment Bone Graft to treat foot and ankle fractures. BioMimetic expects a...
08:00 , Jan 10, 2011 |  BioCentury  |  Finance

Buyside View XIX: Commercial Risk

Michael Flanagan Senior Writer  BioCentury's 19th Annual Buyside View finds money managers entering 2011 cautiously optimistic about biotech's prospects, particularly as some of the high-profile compounds have already reported some data, lowering risk. Amidst the...
07:00 , Jul 26, 2010 |  BC Week In Review  |  Clinical News

Augment Bone Graft: Final Phase III data

Final data from the modified intent-to-treat (mITT) population (n=397) of a U.S. and Canadian Phase III trial showed that Augment Bone Graft was non-inferior to autograft on 15 of 16 radiographic, clinical, functional and pain-related...
07:00 , Jul 5, 2010 |  BC Week In Review  |  Clinical News

Augment Bone Graft regulatory update

FDA accepted for filing a PMA from BioMimetic Therapeutics for Augment Bone Graft to treat foot and ankle fractures that require fusion. The company expects an advisory committee meeting to be scheduled for late this...