French regulators approve EDAP HIFU, study for rectal endometriosis

EDAP 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. "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.