EDAP TMS S.A. announced that it has completed enrollment in its Phase 3 study (Endo-HIFU-R2) evaluating Focal One High-Intensity Focused Ultrasound therapy for the treatment of deep infiltrating rectal endometriosis. The ongoing Phase 3 study is a comparative, randomized, double blind trial, with the primary objective of evaluating acute pelvic pain levels in 60 patients. Select treated patients are followed three months post-HIFU treatment in comparison to a sham group.

The last patient was treated in January. Study results are expected in the second half of 2024.