Focal One®

2025 Industry Award for Innovations in Endourological Instrumentation

Focal One® is the most advanced robotic non-invasive focal HIFU platform designed for the precise ablation of localized prostate cancer using High-Intensity Focused Ultrasound (HIFU). By integrating the latest diagnostic tools such as MRI, PSMA-PET, AI-driven tumor maps and 3D biopsy locations combined with high resolution real-time ultrasound imaging, Focal One allows clinicians to target cancerous tissue with sub-millimeter accuracy, sparing surrounding structures and preserving prostate function. The system’s robotic arm and fusion imaging software enable optimized planning and execution of treatments, minimizing patient morbidity and recovery time.

Developed in collaboration with world leaders in urology, Focal One offers a valuable tool in the growing field of focal therapy, aligning with the trend toward organ-sparing and personalized treatment strategies. Its publication-proven efficacy in treating low- to intermediate-risk prostate cancer positions it as a compelling alternative to radical interventions, particularly for patients seeking to avoid the side effects associated with surgery or radiation. With increasing adoption worldwide, Focal One represents a significant advancement in endourologic oncology care.

Focal One is a product of EDAP TMS, a recognized leader in robotic energy-based therapies. EDAP TMS develops, manufactures, promotes and distributes worldwide minimally invasive medical devices for various conditions using ultrasound technology. By combining the latest technologies in imaging, robotics and precise non-invasive energy delivery, EDAP TMS introduced the Focal One® in Europe and in the U.S. as the leading prostate focal therapy controlled by urologists with the potential to expand to multiple indications beyond prostate cancer. For more information on the Company, please visit https://focalone.com.

Ryan Rhodes
Chief Executive Officer

Hugo EMBERT
VP, Marketing & Reimbursement