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 is currently recruiting patients in a pivotal study in North America to assess 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 the United States and Canada.  The Company has already begun enrolling patients in centers throughout Canada.

Further, the Company has submitted an Investigational Device Exemption (IDE) to the Food & Drug Administration (FDA) for this study and is currently finalizing the statistical plan.    Based on the most recent discussions with the FDA regarding the Augment Injectable study, the Company expects to begin enrolling patients at its U.S. study sites in the first half of 2010.

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