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February 1, 2013
08:35 EDTEDAPEDAP submits FDA PMA application for Ablatherm-HIFU
EDAP TMS announced the submission of its Pre-Market Approval, or PMA, application to the FDA on January 31 for the company's Ablatherm-HIFU. or High Intensity Focused Ultrasound, for treatment of low risk, localized prostate cancer. EDAP's PMA submission includes data from the ENLIGHT study, a multi-center U.S. Phase II/III clinical trial that completed the two-year follow-up needed to evaluate its primary endpoint in August 2012, as well as data from the company's extensive worldwide database of treatment information and follow-up data from patients who have undergone HIFU therapy for prostate cancer.
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