EDAP TMS (NASDAQ:EDAP), a global leader in robotic energy-based therapies, announced record financial results for the fourth quarter and full year ended December 31, 2025.
The company’s performance was highlighted by a significant expansion of its High-Intensity Focused Ultrasound (HIFU) segment, which has become the primary engine of its global growth strategy.
Total HIFU revenue for the full year 2025 rose 39% year-over-year, a milestone driven largely by the continued commercial success of the Focal One robotic platform.
Management cited a combination of robust system sales and a steady increase in U.S. procedure volumes as the key catalysts for the record-breaking figures.
The Focal One system, which allows for the precise, non-invasive ablation of prostate tissue, continues to gain traction among major U.S. academic centers and community hospitals.
In addition to the 2025 performance, EDAP reiterated its financial outlook for the coming year.
The company expects total revenue for 2026 to fall within the range of $72 million to $80 million.
Within this guidance, the core HIFU business is projected to maintain its momentum, with anticipated year-over-year growth of 34% to 45%.