EDAP TMS SA announced record fourth quarter and full-year 2025 revenue for its HIFU business, driven by strong system placements and procedure growth.
The company reported significant growth in Focal One system placements and an increase in the number of U.S. Focal One procedures.
Preliminary unaudited financial results for Q4 2025 show the highest quarterly HIFU revenue in company history.
Record Revenue
Expected fourth quarter HIFU revenue to range between $12.9 million and $13.3 million, representing the highest quarterly revenue ever.
System Placements
Record 15 Focal One system placements in Q4, reflecting strong global demand from hospitals and urology centers.
Procedure Growth
Approximately 28% YoY growth in U.S. Focal One procedures in Q4, demonstrating increasing utilization across systems.
2026 Guidance
Issued initial financial guidance for 2026, expecting core HIFU business revenue to be $50.0 million to $54.0 million.
- The strong performance in 2025 and the positive growth outlook for 2026 showcase EDAP's leadership in robotic energy-based therapies.
- Increasing demand and utilization of the Focal One system point towards a growing market acceptance and adoption of focal therapy for prostate cancer.
EDAP TMS SA's record revenue and growth in 2025, along with the issuance of guidance for 2026, reflect the company's commitment to innovation and market leadership in the field of energy-based therapies.