Therapeutic ultrasound company EDAP TMS said that the Phase 3 trial of robotic high-intensity focused ultrasound (HIFU) therapy for the treatment of deep infiltrating endometriosis (DIE) had shown safety but did not meet the primary endpoint (PE).
The late-stage study involves a comparative, randomised, double-blind trial with 60 patients.
Its primary aim is to assess acute pelvic pain levels. All patients were monitored for an initial three-month period following either HIFU therapy or sham treatment.
According to the interim results of the trial, the primary endpoint of reduced acute pelvic pain in the HIFU treatment arm was not achieved compared to the sham treatment arm.
However, the robotic HIFU therapy remained safe and effective for patients with deep infiltrating endometriosis.
Both study groups also showed significant reductions in pelvic pain scores three months after treatment as measured by the Visual Analog Scale (VAS).
The findings were consistent with findings from earlier Phase 1 and Phase 2 trials.
EDAP TMS, which is listed on Nasdaq, said that the three-month follow-up period was insufficient to detect clinically significant differences in pain scores between the two groups.
MRI assessments revealed that patients treated with robotic HIFU therapy experienced greater reductions in the volume of endometriosis nodules compared to those in the Sham treatment group.
The Phase 3 study is ongoing as per the protocol. Some patients initially assigned to the sham treatment arm have opted to receive HIFU therapy after their pelvic pain returned to baseline levels.
EDAP TMS CEO 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 stabilisation of pain scores at six and twelve months observed in the Phase 2 study.”
EDAP TMS globally develops, manufactures, and distributes minimally invasive medical devices.
Its robotic HIFU devices, including the Focal One, provide advanced imaging and treatment capabilities for optimal prostate tissue ablation in Europe and the US.
The company also offers ExactVu Micro-Ultrasound devices for prostate cancer management and Sonolith i-move lithotripter and lasers for treating urinary tract stones.
In March 2024, EDAP TMS received breakthrough device designation from the US Food and Drug Administration (FDA) for its Focal One platform to treat deep infiltrating rectal endometriosis.
