EDAP Announces Completion of Enrollment in Phase 3 Study Evaluating Focal One HIFU Therapy for the Treatment of Deep Infiltrating Rectal Endometriosis

• 60 Patients Completed Enrollment in Under 9 Months
• Study Results Expected in the Second Half of 2024

LYON, France, February 1, 2024 - EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, announced today 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 (NCT05755958) 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.”   

Rectal endometriosis induces lesions associated with painful symptoms that can seriously alter quality of life for many women. Focal One HIFU is a non-invasive ablative procedure using a high-intensity ultrasound probe to deliver tissue devitalization through use of acoustic cavitation and thermal ablation.

In January 2022, EDAP reported positive results from the Phase 2 Endo-HIFU-1R study (N=60) evaluating Focal One HIFU for the treatment of deep infiltrating rectal endometriosis. Results from the study 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 showed a significant decrease of the evaluated symptoms (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, noting a significant reduction of the volume of lesions observed at six months.