EDAP Submits FDA Pre-Market Approval App for Ablatherm-HIFU for Prostate Cancer

EDAP TMS SA (Nasdaq: EDAP), theglobal leader in therapeutic ultrasound, announced today the submission of itsPre-Market Approval (PMA) application to the U.S. Food and Drug Administration(FDA) on January 31, 2013 for the Company's Ablatherm-HIFU (High IntensityFocused Ultrasound) for treatment of low risk, localized prostate cancer.EDAP's PMA submission includes data from the ENLIGHT study, a multi-centerU.S. Phase II/III clinical trial that completed the two year follow-up neededto evaluate its primary endpoint in August 2012, as well as data from theCompany's extensive worldwide database of treatment information and follow-updata from patients who have undergone HIFU therapy for prostate cancer.Prostate cancer is currently the most common form of cancer among men in theUnited States with approximately 238,000 new cases for 2013. In addition, menare being diagnosed at an earlier age and at earlier stages of the disease.