EDAP TMS shares surge 11.41% premarket after reporting record HIFU revenue, 69% Focal One placement growth, and 2026 guidance.

EDAP TMS surged 11.41% in premarket trading following the release of record preliminary HIFU revenue for Q4 2025 and full-year 2025, driven by a 69% year-over-year increase in Focal One system placements and 28% growth in U.S. procedures. The company projected Q4 2025 HIFU revenue of $12.9–$13.3 million and full-year revenue of $36.7–$37.2 million, marking historic highs. Strong demand for its Focal One system, coupled with 2026 revenue guidance of $50–$54 million, signaled robust market adoption and clinical validation. CEO Ryan Rhodes highlighted the role of clinical trials in accelerating hospital network adoption, reinforcing confidence in the company’s recurring revenue model. The premarket rally reflects investor optimism over sustained growth in its core HIFU business and expanding global utilization.