French device company EDAP TMS has released interim data from the Phase III trial of its robotic high-intensity focused ultrasound (HIFU) therapy for treating deep infiltrating endometriosis.
The trial did not meet the primary endpoint of reduced acute pelvic pain in the HIFU treatment arm compared to the Sham treatment arm. The company attributed the failure to meet the primary endpoint in the interim to the three-month follow-up duration being “too short” to demonstrate a significantly meaningful difference in the pain scores.
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EDAP’s chief executive officer, Ryan Rhodes, said: “Although this initial data shows similar levels of improvement in pelvic pain scores between the two arms, we believe that a therapeutic benefit favouring robotic HIFU is more likely to be confirmed over a longer period of time post-procedure, as suggested by the stabilization of pain scores at six and twelve months observed in the Phase II study.”
The HIFU treatment showed a significant reduction in pelvic pain scores three months from baseline, as measured by the Visual Analog Scale (VAS). Furthermore, the patients in the HIFU treatment arm experienced higher volume reductions in the endometriosis nodule as compared to patients in the Sham treatment arm, measuring using MRI. The company plans to provide an additional trial update later this year.
Deep infiltrating endometriosis is a severe form of endometriosis and occurs when uterine tissue grows deep within your pelvic organs. This can cause severe pelvic pain, as well as pain during urination, sex, and menstrual periods. As per the World Health Organization (WHO), endometriosis affects about 10% of reproductive-aged women and girls globally.
EDAP’s robotic HIFU therapy is a non-invasive ablation procedure that uses a high-intensity ultrasound probe for delivering tissue devitalisation by using acoustic cavitation and thermal ablation. In March 2024, the device received a breakthrough device designation from the US Food and Drug Administration (FDA).
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