Today, worldwide therapeutic ultrasound leader EDAP TMS SA announced that its pre-market approval (PMA) application for Ablatherm-HIFU (high intensity focused ultrasound) was submitted to the FDA on Jan. 31 for the treatment of low-risk, localized prostate cancer. The company’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 to evaluate its primary endpoint – as well as data from EDAP’s expansive global database of treatment information and follow-up data from patients who have undergone HIFU therapy for prostate cancer.
Currently the most common form of cancer among men in the U.S., prostate cancer will manifest in approximately 238,000 new cases in 2013. Men are additionally being diagnosed at earlier ages and earlier stages of the disease. There has been a clear paradigm shift in prostate cancer as patient diagnosis is occurring earlier than ever before, and low-risk patients are resultantly in need of a middle ground between radical treatment – often over-aggressive – and the anxiety of watching and waiting. Well-positioned to address this unmet medical need, Ablatherm-HIFU provides a unique, non-invasive, fully robotic treatment option.
EDAP’s PMA submission to the FDA is an important milestone in Ablatherm-HIFU’s U.S. regulatory process. The company’s EDAP team, as well as its clinical, regulatory, and legal advisors, has dedicated six years to conducting the U.S. clinical trial that explored Ablatherm-HIFU’s treatment potential for localized prostate cancer.
“I am very proud of the team,” said EDAP TMS CEO Marc Oczachowski, “and we will continue to work closely with the agency during the final stages of the process.”
For more information about EDAP TMS SA, visit www.edap-tms.com
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