12:00 AM
Jul 16, 2012
 |  BC Week In Review  |  Clinical News  |  Regulatory

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 for additional information despite an advisory panel's positive vote last year on the product (see BioCentury, Jan. 9). Additional data in the amendment show that the primary endpoint in the company's Phase III trial - non-inferiority to autograft based on fusion rates as measured by CT scan at 24 weeks - is reproducible based on new blinded inter-observer assessments of the scans (95% correlation and 87% concordance). In the response letter, FDA also requested that BioMimetic analyze a new composite endpoint that includes radiological, clinical, functional and safety parameters. An analysis of the...

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