- The Company continues to focus on advancing its Augment ® Bone Graft Pre-Market Approval (PMA) application through the FDA review process. In September 2012, the Company amended its PMA to include the results of a study conducted on becaplermin (Regranex ®) to evaluate cancer mortality. The results of the study, presented at the Second Annual Meeting of The American College of Wound & Tissue Repair, indicated no difference in either cancer incidence or cancer mortality in 12,858 matched patients (Regranex vs. no Regranex) who were recorded in the Veterans Affairs and Medicare patient records and followed for up to 11 years to identify new malignancies and cancer-related deaths. Regranex contains the same synthetic protein that is found in Augment, but is topically administered onto open skin sores daily for weeks to months compared to the one-time implantation of Augment during foot and ankle fusion surgery. Given that the same protein therapeutic is used in both Regranex and Augment, the Company believes these data strengthen the case for approval of Augment.
- In June 2012, the Company submitted to the FDA an amendment to its 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 FDA is actively reviewing the amendment and has 180 days from the date of the filing to respond, although there can be no assurance that this timeline will not be extended. The Company reiterates guidance for a complete response letter from FDA around year-end and a final approvability decision between April 2013 and January 2014.
- Augment Bone Graft was recently listed on the Australian Private Health Insurance Prostheses List, enabling a full launch into this market in September.
- Following the June release of top-line data from the Canadian registration study comparing Augment ® Injectable Bone Graft to autograft in foot and ankle fusion surgery, the Company recently filed a Device License Application (DLA) with Health Canada for approval to market the product candidate in Canada. The Company also intends to file for approval of Augment Injectable in other countries in the coming months. Additionally, all 105 patients enrolled in the North American randomized controlled clinical trial have completed six months follow-up, the time of the primary endpoint for the study. The patients will continue to be followed to assess safety. If the Company determines it won’t re-initiate enrollment, it expects results of the trial will be unblinded and available in the first half of next year.
- The Company has elected to proceed with its Augment ® Chronic Tendinopathy 100 patient dose ranging Phase II clinical trial. A contract research organization has been retained to assist in managing the trial. Patient enrollment is expected to begin in the first half of next year.
BioMimetic Therapeutics, Inc. Reports Third Quarter 2012 Financial Results
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