Enrollment Completion! Ultrasonic surgical robot for deep infiltrating rectal endometriosis completes important clinical enrollment

February 1st, 2024 - EDAP TMS SA, a global leader in robotic ultrasound therapy, announced that it has completed patient enrollment in a Phase III study. The study was designed to evaluate the Focal One High Intensity Focused Ultrasound (HIFU) platform for the treatment of deep infiltrating endometriosis of the rectum.

Endometriosis is a chronic, progressive disease that affects nearly 10-12% of women of childbearing age. The disease is characterized by the growth of endometrial tissue outside the uterus. Normally, the endometrium is a tissue that exists only in the uterine cavity, where it thickens, sheds, and passes out of the body during each monthly menstrual cycle. However, in endometriosis, this tissue grows outside the uterus in places such as the pelvis, ovaries, fallopian tubes, bladder, and bowel. The space between the uterus and the rectum is known as the Douglas' Trap and is one of the most common and symptomatic areas leading to endometriosis of the rectum.

Latest Clinical Developments in Focal One Robotics

Rectal endometriosis causes lesions associated with painful symptoms that can severely impact a woman's quality of life.Focal One HIFU is a non-invasive ablation procedure that uses a high-intensity ultrasound probe to achieve tissue inactivation through acoustic cavitation and thermal ablation.

The ongoing Phase III study (NCT05755958) is a controlled, randomized, double-blind trial with the primary objective of assessing acute pelvic pain levels in 60 patients. Patients selected for treatment will be followed up three months after HIFU treatment for comparison with the sham-operated group. The last patient was treated in January. The results of the study are expected to be published in the second half of 2024.

Ryan Rhodes, Chief Executive Officer of EDAP TMS, said, "Patient enrollment has been completed for the Phase III study, which will be a significant clinical milestone. The Phase III study includes a sham-operated control group, and the fact that enrollment was completed so quickly demonstrates the strong interest of patients and physicians in exploring alternative treatment modalities to surgery. Rectal endometriosis is a painful and debilitating condition that affects thousands of women each year, and surgical intervention is the primary option in addition to medication. Developing a safe and effective treatment option using robotic HIFU to address this significant unmet need in women's health is significantly less invasive than traditional surgical approaches."

In January 2022, EDAP reported positive results from the Phase II Endo-HIFU-1R study (N=60), which evaluated the efficacy of Focal One HIFU for the treatment of deep infiltrating endometriosis of the rectum. The study results showed a favorable safety profile, with 96.7% of patients experiencing no or no significant adverse events (Clavien 1), 3.3% of patients experiencing Clavien 2 complications, and no patients experiencing Clavien 3 complications.

The study also assessed the effect of HIFU treatment on endometriosis symptoms and quality of life (QoL). The results showed a significant reduction in the symptoms assessed (acute pelvic pain, dyspareunia, diarrhea, constipation, rectal bleeding, pseudo impulsivity, lochia, rectal junk, posterior pelvic pain and weakness) compared to the first post-treatment assessment (at one month), with a sustained reduction in the symptoms observed at the three- and six-month nodes after HIFU treatment. In terms of quality of life measures, improvement in patients' quality of life was also observed from the first month after HIFU treatment. The study also assessed changes in nodal volume by MRI, and a significant reduction in lesion volume was observed at six months.

Focal One Robotic High Intensity Focused Ultrasound (HIFU) Platform

The Focal One Robotic HIFU platform is designed for urologists for the focal ablation of prostate tissue. It combines the innovative technologies of imaging, robotics and HIFU to precisely identify and ablate target diseased tissue while avoiding critical structures. Its robotic positioning system provides enhanced precision through five degrees of freedom and automatic safety features, and a dynamic focusing probe combines high-resolution real-time ultrasound imaging with precise HIFU energy delivery to extend coverage and speed treatment. Meanwhile, Fusion HIFUsion software allows urologists to import, visualize and perform MRI or 3D biopsies at the time of treatment. The integrated workstation flexible cart system provides similar service to a standard hospital surgical bed.

HIFU removes lesions by converging ultrasound waves to create a compliant ultrasound focal point; similar to the way a solar cooker focuses sunlight to create a large amount of energy at the focal point, the focused ultrasound waves instantly raise the temperature of the tissue in the lesion to 65-85 degrees Fahrenheit, causing irreversible coagulative necrosis at the local level that kills the cells.The Focal One has received regulatory approval and is available for sale in the U.S., Europe, Korea, Brazil, and other countries, Focal One has received regulatory approval and is available in the United States, Europe, Canada, South Korea, Russia, Brazil and other countries. Focal One is indicated for the ablation of prostate tissue in the U.S. Focal One is a registered trademark of EDAP TMS. The Company operates through two segments, HIFU and UDS (including lithotripsy). The HIFU technology (High Intensity Focused Ultrasound), combined with the robotic HIFU device, Ablatherm Fusion and Focal One, is used for the minimally invasive treatment of prostate diseases.