BioMimetic Therapeutics, Inc. (BMTI) announced that it has submitted to the Food and Drug Administration or FDA an amendment to its Pre-Market Approval or PMA application for Augment Bone Graft for its use as an alternative to autograft in hindfoot and ankle fusion procedures.
The company said the amendment provided supplemental information requested by the FDA in a post-panel response letter announced by the Company earlier this year.
The additional data provided in the amendment demonstrate that the primary endpoint, fusion (defined as at least 50% osseous bridging) on 24 week CT scans, is highly reproducible based on new blinded inter-observer assessments. The Company contracted with an independent radiology contract research organization, which provided an independent board certified radiologist to read all 24-week CT scans for the primary endpoint to determine inter-observer reliability. These assessments demonstrate strong inter-observer correlation (95%), kappa (0.72) and concordance (87%).
There is also high intra-observer reliability when assessing the primary endpoint. Per the FDA's request, the Company also contracted with the original board certified musculoskeletal radiologist to re-read all 24-week CT scans to determine intra-observer reliability. These assessments demonstrate strong intra-observer correlation (99%), kappa (0.87) and concordance (95%).
No differences exist between treatment groups across detailed subgroup analyses specifically requested by the FDA or additional subgroups identified by the Company.
In accordance with the Company's belief, based on discussions with the FDA's Center for Devices and Radiological Health or CDRH senior management, no black box warning should be required for Augment, BioMimetic said.
The company said that the view is in agreement with both oncologists on the Orthopaedic and Rehabilitation Devices Panel of the FDA's Medical Devices Advisory Committee (Advisory Panel) that Augment poses no demonstrable safety risk, and is further supported by new data presented in the amendment.
The FDA has 180 days from the date of the filing to review and respond to the PMA amendment. Assuming that the FDA takes the specified six months post submission to respond and that they have a second round of questions, the company continues to anticipate a final approvability decision between April 2013 and January 2014.
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