EDAP Reports Interim Results From Phase 3 Study Evaluating Robotic HIFU For Deep Infiltrating Endometriosis
$EDAP
Biotechnology: Electromedical & Electrotherapeutic Apparatus
Health Care
- Robotic HIFU therapy continues to maintain an excellent safety profile, confirming positive safety data from prior Phase 1 and 2 studies in patients with deep infiltrating endometriosis
- At three months post procedure, the study's primary endpoint of reduced acute pelvic pain in the HIFU treatment arm compared to the Sham treatment arm was not met
- Significant improvements were observed across primary and secondary outcome measures (endometriosis and digestive symptoms) across the entire study population at three months
- The Phase 3 study continues as planned per protocol, with patients from the Sham treatment arm electing HIFU therapy