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EDAP Announces Positive Results from Phase 2 Study Evaluating Focal One® for the Treatment of Rectal Endometriosis

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EDAP TMS SA has announced positive clinical results from the Endo-HIFU-R1 Phase 2 study evaluating the safety of therapeutic high-Intensity focused ultrasound (HIFU) 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 Paris Santé Femmes French Congress(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.

“These encouraging results validate the safety of Focal One HIFU treatment in this difficult and challenging endometriosis population,” said Marc Oczachowski, Chairman and Chief Executive Officer of EDAP TMS. “Positive data from the Endo-HIFU-R1 study represent an important milestone for EDAP and also underscore the potential of Focal One Robotic HIFU as a promising new treatment modality for patients suffering from this debilitating pathology. We would like to thank all of the patients and clinical investigators who participated in this important study. Based on these results, EDAP TMS intends to confirm the efficacy of Focal One HIFU treatment in rectal endometriosis by initiating a randomized, double-blind controlled study in the second quarter of 2023.”

“Surgery is typically done to excise or ablate the lesions and surrounding fibrotic tissue in patients with significant rectal endometriosis, which is often associated with post-surgical morbidities, including up to 15% of such patients who will present Clavien 3 complications requiring a second surgical or radiological procedure under anesthesia,” said Pr. Gil Dubernard, Study Coordinator of the Endo-HIFU-R1. “Based on the positive safety results from the Endo-HIFU-R1 study, the hyper-accurate mapping of targeted lesions made possible through use of this HIFU-based therapy may represent a viable treatment approach that could lead to decreased post-operative morbidity rates compared to traditional surgical intervention. In addition, according to these encouraging results, we believe that the use of HIFU for the treatment of rectal endometriosis could be considered as an alternative to rectal surgery. In a few months, this mini-invasive approach should be offered in case of failure of hormonal treatment instead of surgery. I look forward to seeing this technology advance further into clinical testing.”

Endo-HIFU-1R Study Results
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.

1 Paris Santé Femmes is a National Event gathering experts and obstetric surgeons community in France (https://paris-sante-femmes.fr/).

Source: EDAP TMS

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