EDAP TMS S.A. (FocalTherics)

EDAP TMS S.A. is a global leader in therapeutic ultrasound, specializing in the development, manufacturing, promotion, and distribution of minimally invasive medical devices for urology. Founded in 1979 and headquartered in Lyon, France, the company's mission is to advance the clinical adoption of its patented focused ultrasound-based robotic therapy platforms through continuous innovation, robust clinical evidence generation, physician education, and global market development initiatives.

The company's core business is centered on High-Intensity Focused Ultrasound (HIFU) technology, primarily for localized prostate tissue ablation. Its flagship product, the Focal One® Robotic HIFU system, integrates advanced imaging, real-time treatment planning, robotic precision, and HIFU technology. While historically involved in extracorporeal shock wave lithotripsy (ESWL) systems, EDAP TMS S.A. is transitioning to an exclusive focus on robotic focal therapy, with plans to classify its ESWL and distribution segments as discontinued operations. The Focal One system is approved for prostate tissue ablation in the United States and has regulatory clearances in numerous other countries, including Europe, Canada, Korea, Russia, and Brazil. The company is also exploring expanding its HIFU technology to treat other conditions, such as endometriosis and pancreatic cancer.

EDAP TMS S.A. recently announced a corporate brand transition to "FocalTherics" to better reflect its strategic focus on high-growth robotic focal therapy, though its legal name remains EDAP TMS S.A. Ryan Rhodes serves as the Chief Executive Officer. In May 2026, the company entered into a collaboration with Telix Pharmaceuticals Limited to investigate combining Focal One Robotic HIFU with PSMA PET imaging for prostate cancer management. The French Ministry of Health approved reimbursement for the Focal One Robotic HIFU procedure, effective September 1, 2025. The company reported strong financial performance in Q1 2026, with record HIFU revenue, demonstrating 78% year-over-year growth in this segment. In April 2025, EDAP launched the new Focal One® i Robotic HIFU system, enhancing imaging compatibility and introducing capabilities for remote collaborative procedures.