EDAP TMS makes and sells the Focal One Robotic HIFU (High Intensity Focused Ultrasound) system, a medical device that treats localized prostate cancer by ablating targeted tissue non-invasively using focused ultrasound energy. The system integrates real-time ultrasound imaging, MRI fusion, robotic positioning, and treatment planning software to give physicians precision in targeting cancerous tissue while sparing surrounding structures. Focal One is positioned as a middle-ground option between active surveillance and radical treatments like surgery or radiation. EDAP sells directly to hospitals, academic medical centers, and urology clinics in the U.S. and key European and Asian markets, with distributors elsewhere. EDAP generates revenue from three streams: capital sales of Focal One systems, single-use disposables consumed per procedure, and service contracts on the installed base. Capital sales are lumpy and drive growth, while the expanding installed base compounds recurring disposable and service revenue over time. EDAP is winding down its legacy noncore businesses — ESWL systems and third-party urology product distribution — to focus exclusively on HIFU. Beyond prostate cancer, EDAP is pursuing indication expansion into BPH, with a U.S. clinical trial underway, and deep infiltrating rectal endometriosis, where EDAP received CE Mark in 2025 and FDA Breakthrough Device designation. EDAP manufactures in Lyon, France, and imports finished goods into the U.S., exposing the company to tariff costs on U.S. shipments.