EDAP TMS, a developer of invasive medical devices, has received the US Food and Drug Administration’s (FDA) breakthrough device designation for its Focal One platform to treat deep infiltrating endometriosis (DIE).
The FDA approved the Focal One high-intensity focused ultrasound (HIFU) system for prostatic tissue ablation in June 2018.
A non-invasive, robotic ablative procedure, Focal One HIFU uses a high-intensity ultrasound probe for delivering tissue devitalisation by using acoustic cavitation and thermal ablation.
Positive results from the Phase II Endo-HIFU-1R study, which included 60 participants, were pivotal in EDAP’s FDA submission for the breakthrough device designation.
The study demonstrated significant symptom reduction and quality of life improvements post-treatment, with a notable decrease in lesion volume confirmed by MRI at six months.
EDAP is undertaking a Phase III study (Endo-HIFU-R2) to further evaluate Focal One HIFU therapy in reducing acute pelvic pain associated with DIE.
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The company anticipates results from this randomised, double-blind trial in the latter half of 2024. The last patient was treated earlier this year, as part of the study.
EDAP TMS CEO Ryan Rhodes said: “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.
“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.”
