EDAP Completes Follow-Up Phase and Data Collection for FDA ENLIGHT Trial
EDAP TMS SA, today provided an update regarding its Ablatherm-HIFU (High Intensity Focused Ultrasound) ENLIGHT U.S. clinical trial for the indication of low risk, localized prostate cancer. The trial is a multi-center U.S. Phase II/III clinical trial conducted under an Investigational Device Exemption (IDE) granted by the FDA. As previously announced, the last Ablatherm-HIFU patient was treated in June 2010. The two year anniversary of the last patient treated occurred on June 30, 2012, which marked the conclusion of the two year follow-up phase, and the Company confirms the completion of all two year follow-up visits.
John Rewcastle, Medical Director of EDAP-TMS, remarked, "After the second anniversary of the last patient treated, and according to the approved protocol, patients have two months to present at the trial sites for their last follow-up visit. Now that every patient has completed their follow-up visit, we will be in a position to commence the clinical analysis of the collected data. In parallel with this analysis, EDAP's team in the U.S. and France has already started to compile the comprehensive Premarket Approval (PMA) submission that includes a detailed review of the Company's technical and manufacturing capabilities, along with the clinical analysis of the collected U.S. patient data."
Marc Oczachowski, Chief Executive Officer of EDAP-TMS, stated, "Our integrated team in the U.S. and France is committed to assembling the technical, non-clinical laboratory studies and clinical investigations sections of the submission, which is hundreds of pages long. We are on track to submit the filing to the U.S. FDA in the fourth quarter of 2012."