EDAP TMS SA, a global leader in robotic energy-based therapies has granted the FDA Breakthrough Device designation for the treatment of infiltrating endometriosis (DIE). The Focal One Robotic Focal HIFU received its FDA clearance for the ablation of prostatic tissue in 2018.
 
“Receiving Breakthrough Device designation from the FDA represents a major milestone and reinforces our commitment to expand the use of Focal One Robotic HIFU technology to treat other patient conditions beyond prostate disease,” said Ryan Rhodes, Chief Executive Officer of EDAP TMS. “This designation reflects the FDA’s recognition that deep infiltrating endometriosis remains a significant unmet medical need in women’s health with few treatment alternatives. By expanding our proprietary robotic HIFU technology, we aim to provide women with a safe and effective treatment option that is significantly less invasive and less morbid than conventional surgical approaches.”
 
The Breakthrough Device designation for the Focal One system marks a significant development for DIE patients. Rectal endometriosis lesions are associated with painful symptoms that can alter quality of life for many women. 
 
Focal One is a non-invasive robotic ablative procedure that uses a high-intensity ultrasound probe to deliver tissue devitalization through the use of acoustic cavitation and thermal ablation. 
 
EDAP reported positive results from the Phase 2 Endo-HIFU-1R study in January of 2022. This data led to the FDA’s designation.
 
The study evaluated the effect of HIFU treatment of endometriosis symptoms and quality of life. Results showed a significant decrease of the evaluated symptoms including acute pelvic pain, dyspareunia, diarrhea, constipation, rectal bleeding, false urges, tenesmus, rectal spams, posterior pelvic pain, and asthenia. Symptoms were reduced from the first post-treatment evaluation (at one month) and were maintained for three and six months following HIFU treatment.
 
Enrollment for the Phase 3 study evaluating Focal One HIFU therapy for treating deep infiltrating rectal endometriosis was completed in February 2024. The ongoing study is a comparative, randomized, double-blind trial, primarily evaluating acute pelvic pain levels in 60 patients. Study results are expected in the second half of 2024.