EDAP TMS S.A. has reiterated its 2026 core HIFU revenue guidance of $50 million to $54 million [1].
This financial outlook follows a record-breaking start to the year, signaling strong market adoption of the company's robotic surgical technology in the U.S. and international markets.
The company reported total revenue of $17.8 million [3] for the first quarter of fiscal 2026. Within that total, revenue from the Focal One Robotic HIFU system reached $11 million [4]. Management said the growth was due to the continued adoption of the Focal One system and broader international expansion [5].
Activity in the U.S. market showed significant gains, with HIFU procedures increasing 53% year-over-year [2]. Other growth metrics indicate a broader surge in demand, including an 83% year-over-year increase in Focal One shipments [7]. Overall HIFU revenue grew by 78% compared to the previous year [6].
"As announced this morning, we delivered a strong first quarter," EDAP management said [8].
The company expects the 2026 core HIFU revenue to represent a growth of 34% to 45% over 2025 figures [5]. This projection remains consistent with previous guidance as the company scales its operations globally.
"We expect core HIFU revenue to be in the range of USD 50 million to USD 54 million, representing 34% to 45% growth over 2025," EDAP management said [9].
“U.S. HIFU procedures grew 53% year-over-year.”
The alignment of record first-quarter revenue with a reaffirmed full-year guidance suggests that EDAP is successfully transitioning from a product-launch phase to a scaling phase. The disparity between procedure growth (53%) and shipment growth (83%) indicates that while more machines are being installed, the utilization rate of existing systems is also climbing, creating two distinct revenue streams from both hardware sales and recurring procedure-based income.
