• EDAP TMS has initiated a Phase I/II clinical trial evaluating Focal One robotic HIFU for benign prostatic hyperplasia (BPH) treatment.
• The study aims to determine optimal treatment parameters using Focal One HIFU to improve BPH symptoms with minimal side effects.
• The trial is a prospective, multicenter study conducted in two parts, starting in France and potentially expanding to the United States.
• Focal One's precision in delivering HIFU energy is expected to offer a less invasive BPH treatment option, preserving urethral integrity.