Global therapeutic ultrasound leader EDAP has released an update relating to its Ablatherm-HIFU (High Intensity Focused Ultrasound) ENLIGHT U.S. clinical trial for the indication of low-risk, localized prostate cancer. The multi-center U.S. Phase II/III clinical trial is being conducted under an Investigational Device Exemption (NYSE:IDE) granted by the FDA. The last Ablatherm-HIFU patient was treated in June of 2010, and the two-year anniversary of that treatment took place on June 30, 2012, marking the conclusion of the two-year follow-up phase. The company confirms the completion of all two-year follow-up visits.
According to the approved protocol, following the second anniversary of the last patient treated, patients have two months to present at the trial sites for their last follow-up visit. Now that each patient has completed that follow-up visit, EDAP will be in a position to commence clinical analysis of the collected data. The company's team in the United States and France has already begun compiling the comprehensive Premarket Approval (NYSEARCA:PMA) submission, which includes an in-depth review of EDAP's technical and manufacturing capabilities, as well as the clinical analysis of the collected data of patients in the U.S.
EDAP's integrated team in the United States and France is dedicated to assembling the technical, non-clinical laboratory studies and clinical investigations sections of the PMA submission, which is hundreds of pages long. The company is on track to submit the filing to the FDA in the fourth quarter of 2012.
EDAP is engaged in the development and marketing of Ablatherm, which is the world's most advanced and clinically proven choice for high-intensity focused ultrasound (HIFU) treatment of localized prostate cancer. HIFU treatment is shown to be an effective treatment option that is minimally invasive and has a low occurrence of side-effects. Generally, Ablatherm-HIFU is recommended for patients with localized prostate cancer (stages T1-T2) who are not candidates for surgery or who prefer alternative options, or for patients who have failed radiotherapy treatment. Ablatherm-HIFU has been approved in Europe as a treatment for prostate cancer and is currently undergoing evaluation in a multicenter U.S. Phase II/III clinical trial under an Investigational Device Exemption (IDE) granted by the U.S. FDA, the ENLIGHT U.S. clinical study. EDAP is also developing this technology for the potential treatment of certain other types of tumors. The company additionally produces and commercializes medical equipment (the Sonolith range) for treating urinary tract stones using extra-corporeal shockwave lithotripsy (ESWL).
Please see disclaimer on the MissionIR website http://www.missionir.com/disclaimer.html