EDAP TMS reports interim results from Phase 3 study of Robotic HIFU

EDAP TMS announced interim results from its Phase 3 study evaluating robotic High-Intensity Focused Ultrasound therapy for the treatment of deep infiltrating endometriosis. The Phase 3 study is a 60-patient comparative, randomized, double blind trial, with the primary objective of evaluating acute pelvic pain levels. All patients were initially followed for three months after either the HIFU treatment or the Sham treatment. Interim results: Robotic HIFU therapy continues to maintain an excellent safety profile in patients with deep infiltrating endometriosis, confirming results from earlier Phase 1 and Phase 2 studies. While both arms of the study showed significant reduction in pelvic pain scores at three months from baseline as measured by Visual Analog Scale (VAS), the primary endpoint of reduced acute pelvic pain in the HIFU treatment arm compared to the Sham treatment arm was not met; the Company and the Principal Investigator of the study believe the three-month post-procedure follow-up period was likely too short of a time period to show clinically meaningful differences in pain scores between the two arms of the study. As measured by MRI, patients receiving robotic HIFU therapy experienced higher volume reductions in the endometriosis nodule as compared to patients in the Sham treatment arm. The Phase 3 study continues per protocol, with several patients initially in the Sham treatment arm having elected and already received HIFU therapy after their pelvic pain returned to baseline levels. “The interim results from the ongoing Phase 3 study demonstrate that robotic HIFU therapy continues to maintain an excellent safety profile in patients with deep infiltrating endometriosis. Additionally, the reduction in the volume of the nodules observed in the HIFU arm confirms the therapeutic effect of the HIFU treatment,” said Professor Gil Dubernard, Head of Gynecology Department at Croix-Rousse Academic Hospital, Lyon, France, and Principal Investigator of the Study. “This data is consistent with the prior results from the Phase 2 study that was recently published in the Journal of Human Reproduction1 on the safety and the potential benefit of HIFU treatment for well-selected patients with deep infiltrating endometriosis.” “Although this initial data shows similar levels of improvement in pelvic pain scores between the two arms, we believe that a therapeutic benefit favoring robotic HIFU is more likely to be confirmed over a longer period of time post-procedure, as suggested by the stabilization of pain scores at six and twelve months observed in the Phase 2 study,” said Ryan Rhodes, Chief Executive Officer of EDAP TMS. “Moreover, the cumulative safety and efficacy data from the Phase 1, 2 and 3 studies, suggests that robotic HIFU is a safe, non-invasive treatment and has significant potential to reduce pain for women suffering from this debilitating condition. We are encouraged to see additional patients from the Sham treatment arm elect to be treated with HIFU therapy in accordance with the study protocol, and we look forward to providing another update on the program later this year.”