Clinical Trial Recruitment

BioMimetic Therapeutics product candidates are regulated by the U.S. FDA and other worldwide regulatory agencies.  As a result, all of the BioMimetic's product candidates are subject to evaluation in human clinical trials before they can be marketed.

The Company recently closed enrollment of 75 patients in Canada for a pivotal trial assessing the safety and efficacy of Augment Injectable Bone Graft as a substitute for autograft in foot and ankle fusion procedures.  This randomized, controlled study is intended to support Augment Injectable product registration in Canada.  The Company expects to release data around the end of 2011 or early 2012.

The Company recently initiated patient enrollment in a North American pivotal trial with Augment Injectable for hindfoot and ankle fusion indications.   Based on the most recent discussions with the FDA regarding the study, the Company will enroll 201 patients at approximately 25 institutions in NA.  The Company expects to complete enrollment around mid 2012.

Further, BioMimetic recently completed enrollment in a pilot study in Canada to assess the safety and clinical utility of Augment Rotator Cuff Graft for the repair of large rotator cuff tears. The randomized, controlled pilot trial enrolled up to 30 patients at multiple centers throughout Canada. The study’s objective is to determine the safety and performance of Augment Rotator Cuff for primary surgical treatment of full thickness rotator cuff tears. The Company expects to release data from this trial in the first half of 2012.

For additional information regarding ongoing or future clinical studies, please visit ClinicalTrials.gov.