Urodynamic Systems in Texas

EDAP TMS manufactures and markets the Focal One® robotic HIFU (high-intensity focused ultrasound) platform for non-invasive prostate tissue ablation and focal prostate cancer treatment. The Focal One system is a cart-based, urologist-controlled robotic platform designed for precision ablation of prostate lesions while preserving surrounding healthy tissue. Key system components include: (1) a robotic positioning system with submillimetric precision and five degrees of freedom; (2) HIFUsion® open-platform fusion software enabling import and elastic fusion of MRI and 3D biopsy maps for real-time treatment guidance; (3) an integrated workstation compatible with standard hospital OR beds; and (4) a Dynamic Focusing Probe combining high-resolution ultrasound imaging with HIFU energy delivery. The technology is radiation-free and minimally invasive, allowing patients to maintain quality of life with minimal side effects compared to traditional surgical approaches. Focal One is supported by over 154 peer-reviewed publications and clinical evidence including the landmark HIFI study demonstrating positive outcomes versus surgery in prostate cancer management. The system is positioned to fill a treatment gap in prostate cancer management programs for urology departments and specialized cancer centers. EDAP TMS operates globally with US operations based in Austin, TX.