LYON, France, April 26, 2010 (GLOBE NEWSWIRE) -- EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic ultrasound, today announced its strategy for the ongoing U.S. ENLIGHT Ablatherm-HIFU clinical trial. Following the FDA Gastroenterology and Urology Devices Panel in December 2009 and the Company’s January 2010 meeting with the FDA concerning its recommendations for the trial protocol, the Company has thoroughly evaluated all options aiming at an IDE submission in a feasible timeframe and with acceptable economics. Based on input from its clinical and regulatory advisors and with concurrence of the Board of Directors, EDAP said it will discontinue enrollment in the Ablatherm-HIFU study in the coming weeks and complete the required 2-year follow-up of all patients treated to that date. The resulting data set, which will include outcomes from more than 100 patients, will form the foundation of a submission to the FDA, which the Company expects to occur in 2012. The Company believes that the submission of data from the patients treated in the U.S. ENLIGHT trial, combined with the strong long-term data in Europe where more than 22,000 Ablatherm-HIFU treatments have been performed to date, and compared with the retrospective clinical data on other therapies from existing registries, will provide a strong clinical profile for FDA evaluation.
