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EDAP Announces Approval for Phase II Study

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EDAP Announces Approval for Phase II Study Evaluating High Intensity Focused Ultrasound (HIFU) for Deep Invasive Endometriosis

 


LYON, France, August 25, 2020 -- EDAP TMS SA (Nasdaq: EDAP) (“the Company”), the global leader in robotic energy-based therapies, today announced that the company has received approval from French health authorities to initiate a Phase II multicenter clinical trial evaluating its Focal One® HIFU to treat deep rectal endometriosis.

In this Phase II multicenter study, a single patient group of 38 women with a confirmed diagnosis of deep rectal endometriosis will be treated in a total of five major hospitals in France, and both safety and efficacy will be assessed. This study is planned to commence in September at the Croix-Rousse University Hospital and expand to four additional sites. Pr. Gil Dubernard will serve as lead investigator. Based on the results from this Phase II study, if positive, the company plans to initiate a Phase III, randomized, placebo-controlled study to confirm these outcomes.

 

 

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