EDAP TMS announces completion of enrollment in Phase 3 study of HIFU therapy

EDAP TMS announced that it has completed enrollment in its Phase 3 study, Endo-HIFU-R2, evaluating Focal One High-Intensity Focused Ultrasound, HIFU, 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. “We are pleased to announce the completion of enrollment in our Phase 3 study, which represents a significant clinical milestone for our company,” said Ryan Rhodes, Chief Executive Officer of EDAP TMS. “Considering the fact that the Phase 3 study included a sham-controlled arm, we are highly encouraged by the robust pace of enrollment which we believe speaks to the strong interest from patients and physicians in exploring alternative treatment modalities beyond surgery. Rectal endometriosis is a painful and debilitating condition that impacts thousands of women each year with surgical intervention being the primary option beside medical treatment. By utilizing robotic HIFU, we hope to address this significant unmet need in women’s health by developing a safe and effective treatment option that is significantly less invasive than conventional surgical approaches. We would like to thank the patients and clinical investigators who participated in this study, and we look forward to reporting results from the study later this year.”