February 8, 2013 — EDAP TMS SA announced the submission of its Pre-Market Approval (PMA) application to the U.S. Food and Drug Administration (FDA) on Jan. 31, 2013 for the company's Ablatherm-HIFU (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.
Prostate cancer is currently the most common form of cancer among men in the United States with approximately 238,000 new cases for 2013. In addition, men are being diagnosed at an earlier age and at earlier stages of the disease.
Marc Oczachowski, chief executive officer of EDAP TMS, remarked, "We have clearly seen a paradigm shift in prostate cancer, as patients are diagnosed earlier than ever before. Low risk patients need a middle ground between radical treatment, which is often overly-aggressive, and the anxiety of 'watchful waiting.' Ablatherm-HIFU is well-positioned to address this unmet medical need by providing a unique non-invasive and fully robotic treatment option."
Oczachowski concluded, "The PMA submission to the FDA represents a significant milestone in the U.S. regulatory process for Ablatherm-HIFU. The EDAP team, together with its clinical, regulatory and legal advisors, has devoted six years to conducting the United States clinical trial that studied Ablatherm-HIFU as a treatment for localized prostate cancer. I am very proud of the team, and we will continue to work closely with the agency during the final stages of the process."