BioMimetic Pharmaceuticals, Inc. Initiates Enrollment in E.U. Registration Trial for GEM OS(R)1Bone Graft
6/7/2007 12:27:59 PM
FRANKLIN, Tenn.--(BUSINESS WIRE)--BioMimetic Therapeutics, Inc. (NASDAQ: BMTI) today announced that it has initiated enrollment in a registration (pivotal) study in the European Union (E.U.) to assess the safety and efficacy of GEM OS1 Bone Graft as a substitute for autograft in foot and ankle fusion procedures. The study, which is intended to support GEM OS1 product registration in the E.U., will enroll up to 125 patients at up to 10 clinical centers. The primary endpoint for the study will be fusion rates as measured by CT scan at nine months post surgery. The Company previously reported interim data from U.S. and Canadian clinical trials which demonstrated that fusion rates for GEM OS1 treated patients appeared to be at least comparable to patients treated with autograft taken from elsewhere in the patient’s own body, but without the donor site pain and potential complications of harvesting autograft.
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