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EDAP TMS SA (Nasdaq: EDAP) (“the Company”), the global leader in robotic therapeutic ultrasound, today announced that the Company has received approval from French authorities to initiate a Phase 3 randomized, controlled clinical trial evaluating Focal One high intensity focused ultrasound (HIFU) as a potential treatment for rectal deep infiltrating endometriosis.


Marc Oczachowski, Chairman and Chief Executive Officer of EDAP TMS, stated, “This is great news and a notable milestone for our Focal One HIFU endometriosis program. This level 1 study – the most rigorous trial design – is a multi-center, double blind, randomized, controlled clinical trial. This study will allow us to continue to build strong clinical evidence demonstrating the efficacy and added value of HIFU for patients suffering from this painful and debilitating condition.


“The study will enroll 60 subjects across eight centers in France, with 30 subjects randomized to each group. The primary efficacy endpoint is acute pelvic pain three months post procedure. At the conclusion of the study, subjects in the other group will be offered HIFU treatment.  We look forward to initiating enrollment in this important study in the second quarter of next year.”


This will be EDAP’s third study evaluating Focal One HIFU for endometriosis. The Company recently completed a Phase 2 study evaluating HIFU as a potential treatment for deep infiltrating endometriosis. The Phase 2 study enrolled 60 subjects across four centers in France. Data from this study is currently being analyzed with the anticipation of the final results on safety and efficacy l being presented at a medical meeting in early 2023.




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