Core Insights - Robotic High-Intensity Focused Ultrasound (HIFU) therapy shows significant advantages over traditional surgery for treating deep infiltrating endometriosis, including reduced post-operative complications and shorter hospital stays [1][2][3] Company Overview - EDAP TMS SA is a leader in the global therapeutic ultrasound market, developing and distributing minimally invasive medical devices for various pathologies using ultrasound technology [5] - The company introduced the Focal One® device in Europe and the U.S. for prostate tissue ablation and offers a complete solution from diagnostics to treatment of prostate cancer [5] Study Details - A retrospective multicenter study compared outcomes of 120 patients, with 60 receiving HIFU treatment and 60 undergoing surgical excision for endometriosis [2][3] - The study aimed to evaluate treatment-related improvements in symptoms and morbidity between the two approaches [2] Key Findings - HIFU therapy resulted in fewer moderate and severe post-operative complications compared to surgery, indicating its potential as a viable alternative for select patients [3] - Patients treated with HIFU experienced shorter operating times and reduced lengths of hospital stay [3] Future Developments - The ongoing Phase 3 trial for Focal One HIFU continues, with over 85% of patients from the Sham treatment arm opting for HIFU therapy as their symptoms returned [4] - The company plans to communicate with the FDA regarding the trial data and next steps for the HIFU program [4]
EDAP Announces Scientific Presentation at 2024 AAGL Global Congress Comparing Focal One HIFU Versus Surgery for the Treatment of Deep Infiltrating Endometriosis