EDAP Posts 78% HIFU Revenue Growth to $11.6M and 83% Shipment Rise
EDAP reported $11.6M HIFU revenue in Q1 2026, up 78% year-over-year, driven by record 53% growth in U.S. procedures and 83% increase in Focal One shipments. Total Q1 revenue rose to $17.8M with gross margin up to 45.7% on favorable product mix.
1. Record Q1 HIFU Revenue Growth
EDAP’s HIFU business generated $11.6 million in Q1 2026, a 78% increase year-over-year, driven by 53% growth in U.S. procedures and an 83% jump in Focal One system shipments. Eleven systems sold during the quarter highlight strong global adoption.
2. Company-Wide Financial Performance
Total Q1 revenue reached $17.8 million, up from $14.3 million, while gross margin expanded to 45.7% from 42.0% on favorable product mix. Non-core businesses declined to $6.2 million as the company shifts focus to high-growth HIFU therapy.
3. Guidance and Strategic Priorities
EDAP reiterated full-year core HIFU revenue guidance of $50–$54 million, targeting 34%–45% growth, and non-core revenue of $22–$26 million. The company is prioritizing capital sales in key markets and ramping utilization across its global installed base.