EDAP TMS SA announced positive clinical results from the Endo-HIFU-R1 Phase 2 study evaluating the safety of therapeutic high-Intensity focused ultrasound for the treatment of rectal endometriosis. Results from the study were presented by study coordinator, Pr. Gil Dubernard of Croix Rousse University Hospital (Lyon, France), on Friday, January 27, at the ParisSanté Femmes French Congress1 (Lille, France).

Endo-HIFU-R1 is a Phase 2 study designed to evaluate the safety of HIFU treatment of rectal endometriosis with EDAP's Focal One® Robotic HIFU device. The study enrolled 60 patients across four centers in France between August 2020 and March 2022. Results from the study are based upon a six-month follow-up evaluation post-HIFU treatment.

Treatment with Focal One HIFU showed a positive safety profile with 96.7% of patients with no or non-significant adverse events (Clavien 1), 3.3% of treated patients presenting Clavien 2 complications and zero patients presenting Clavien 3 complications. The study also evaluated the effect of HIFU treatment on endometriosis symptoms and Quality of Life (QoL). Results show a significant decrease of the symptoms level (acute pelvic pain, dyspareunia, diarrhea, constipation, rectal bleeding, false urges, tenesmus, rectal spams, posterior pelvic pain and asthenia) from the first post-treatment evaluation (at one month), and the reduction of symptoms was maintained at three and six months following HIFU treatment.

With respect to QoL measurement, a significant improvement was also observed from the first month after HIFU treatment and maintained at three and six months after treatment for almost all evaluated criteria: physical functioning, role limitation due to emotional problems, energy – fatigue, emotional well-being, social functioning, bodily pain, general health, and on physical and mental global score components. The study also blindly evaluated the evolution of nodule volume via MRI, and a significant reduction of the volume of lesions was observed at six months.