EDAP TMS SA 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. 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.