EDAP Posts 34% Q4 HIFU Growth, Guides 34–45% Core Sales Rise in 2026
EDAP delivered record Q4 HIFU revenue of €11.7M (+34% YoY) and full-year HIFU revenue of €33.1M (+39%), driven by a 69% rise in Focal One system placements and 28% U.S. procedure growth. The company reiterated 2026 revenue guidance of $72M–$80M, expecting core HIFU sales of $50M–$54M (34–45% growth).
1. Q4 and Full-Year HIFU Performance
EDAP’s HIFU business generated €11.7M ($13.5M) in Q4 2025, up 34% year-over-year, and €33.1M ($37.4M) for the full year, a 39% increase. System placements jumped 69% for the year, including 14 cash sales in Q4, while U.S. procedures rose 28%, boosting disposables revenue by 43%.
2. Financial Results and Margin Trends
Total Q4 revenue was €18.9M ($21.9M), down 7%, with gross margin at 42.6% versus 44.8% a year earlier (46.9% ex-tariffs and reserves). Q4 net loss widened to €8.2M ($9.5M) or €0.22 per share, and full-year net loss reached €25.9M ($29.2M) or €0.69 per share, as non-core ESWL and distribution revenue fell 27%.
3. 2026 Guidance and Market Outlook
The company reiterated 2026 revenue guidance of $72M–$80M, targeting core HIFU revenue of $50M–$54M (34–45% growth). Management cites expanding adoption of focal therapy across academic centers, community hospitals and large healthcare networks as drivers for continued platform penetration and procedure volume growth.