- In June 2012, the Company submitted to the Food and Drug Administration (FDA) an amendment to its Pre-Market Approval (PMA) application for Augment ® Bone Graft for its use as an alternative to autograft in hindfoot and ankle fusion procedures. The amendment provided supplemental information requested by the FDA in a post-panel response letter announced by the Company earlier this year. The Company believes the amendment is fully responsive to the FDA’s requests and that the additional data provided in the amendment offer sound scientific evidence, in many cases even stronger than that from the previously available data, demonstrating reasonable assurance of Augment’s safety and effectiveness while sparing patients the pain and morbidity associated with harvesting autograft. The FDA has 180 days from the date of the filing to review and respond to the PMA amendment, although there can be no assurance that this timeline will not be extended. The Company reiterates guidance for a final approvability decision between April 2013 and January 2014.
- In June 2012, investigators announced top-line data from the Company’s Canadian registration study comparing Augment ® Injectable Bone Graft to autograft in foot and ankle fusion surgery. Patients treated with Augment Injectable were shown to have equivalent CT, clinical and functional outcomes with less pain than patients treated with autograft. No safety concerns were identified, and all Augment Injectable treated patients were spared the additional risk and morbidity of bone graft harvest. The Company intends to file the study and other supporting information for approval of Augment Injectable in countries outside the U.S. in the coming months.
- Leading foot and ankle surgeons made numerous presentations at the American Orthopaedic Foot and Ankle Society (AOFAS) annual meeting in June, supporting the safety, effectiveness, clinical need, biologic rationale and cost effectiveness of Augment Bone Graft.
- The Company held its 2012 Annual Meeting of Stockholders in June. The Company’s shareholders voted in favor of all proposals identified in the Proxy Statement. Re-elected to the board of directors for three year terms expiring at the 2015 Annual Meeting of Stockholders were Thorkil K. Christensen, Christopher B. Ehrlich and Charles W. Federico, who are all Class I directors. Stockholders ratified the appointment of Ernst & Young LLP as BioMimetic’s independent registered public accounting firm for the fiscal year ending December 31, 2012. Stockholders also approved the Company’s 2012 Equity Incentive Plan, as well as an amendment to the Company’s 2005 Employee Stock Purchase Plan. Additionally, stockholders approved the compensation of the Company’s named executive officers on a non-binding, advisory basis.
BioMimetic Therapeutics, Inc. Reports Second Quarter 2012 Earnings Results
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