EDAP TMS S.A. (Nasdaq: EDAP), a leader in robotic energy-based therapies, announced its financial results for the fourth quarter and full-year 2025, showcasing significant growth in its High-Intensity Focused Ultrasound (HIFU) business. The company reported a remarkable 39% year-over-year increase in full-year HIFU revenue, driven by a surge in sales of its Focal One® systems and an increase in the number of procedures performed in the U.S. The fourth quarter alone saw a 34% increase in HIFU revenue, amounting to €11.7 million ($13.5 million), compared to €8.8 million ($9.4 million) in the same period last year. The company sold 15 Focal One systems in Q4, with 14 being cash sales, marking a significant achievement in system placements. Additionally, the number of U.S. procedures grew by 28% year-over-year, indicating a strong demand for non-invasive treatment options for early-stage prostate cancer. CEO Ryan Rhodes expressed optimism about the company's future, stating that the demand for Focal One remains robust across various healthcare settings, including academic cancer centers and large integrated healthcare networks. Looking ahead, EDAP TMS has reiterated its revenue guidance for 2026, expecting HIFU revenue to grow between 34% and 45% year-over-year. The company is well-positioned to capitalize on the increasing adoption of focal therapy globally, supported by growing clinical data and patient demand for effective treatment options.

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