EDAP Reports Record HIFU Revenue in Q4 2025, FDA-Cleared Next-Gen Focal One Platform Drives 34% Growth
核心洞察
EDAP TMS achieved record quarterly HIFU revenue of EUR 11.7 million in Q4 2025, a 34% year-over-year increase driven by 14 Focal One capital sales and 22% growth in treatment-driven revenue.
The company received FDA clearance on November 20 for its next-generation Focal One Robotic HIFU (搜索) platform featuring advanced ultrasound imaging and AI-driven treatment planning capabilities.
U.S. Focal One procedure volumes reached their highest quarterly level, growing 28% year-over-year, while the installed base expanded to 165 systems globally.
EDAP TMS S.A. (搜索) delivered its strongest quarter in company history for High Intensity Focused Ultrasound (HIFU) revenue during the fourth quarter of 2025, reporting EUR 11.7 million in core HIFU revenue — a 34% increase over the same period in 2024. The results, disclosed during the company's earnings call on May 7, 2026, underscore accelerating commercial momentum for the Focal One Robotic HIFU (搜索) platform, particularly in the U.S. market.
The quarter was marked by a record 15 global Focal One placements, including 14 cash sales, with the U.S. contributing 10 cash sales — its highest quarterly total on record. "The fourth quarter was the strongest quarter in the company's history for HIFU revenue," said CEO Ryan Rhodes. "This growth was led by capital sales and treatment-driven revenues, which continue to be the driving force of our ongoing commercial success."
FDA Clearance for Next-Generation Platform
On November 20, 2025, EDAP received FDA clearance for the latest evolution of the Focal One Robotic HIFU (搜索) system, which introduces advanced ultrasound imaging and streamlined treatment planning. The next-generation ultrasound imaging engine provides real-time visualization and supports the future development of AI-driven algorithms designed to assist surgeons with tissue ablation visualization and treatment evaluation. This regulatory milestone, combined with the earlier 2025 launch of Focal One i, strengthens the company's leadership position in focal therapy for prostate cancer (搜索).
Expanding Academic and Community Adoption
The profile of Focal One customers continues to be led by leading academic centers and major community hospitals. During Q4, the University of Pennsylvania — an NCCN member institution and NCI-designated Comprehensive Cancer Center — converted its existing HIFU program to Focal One, bringing Focal One adoption to 55% of NCCN member institutions. The University of Pittsburgh Medical Center (UPMC), a Society of Urologic Oncology Approved Fellowship program, was also added to the installed base, increasing penetration to 63% of SUO teaching hospitals in the U.S.
Notably, three major focal therapy programs converted from legacy HIFU technology to Focal One during the quarter, including the University of Pennsylvania, Penn State Health, and Lakewood Ranch Medical Center in Florida. At Lakewood Ranch, Dr. Stephen Scionti — who has treated 2,000 prostate cancer (搜索) patients over more than 20 years using a legacy HIFU platform — transitioned to the Focal One i platform. "His decision to adopt our latest technology further validates our strategy of ongoing innovation," Rhodes stated.
International Expansion and Procedure Growth
International momentum continued with four cash sales outside the U.S., including the first Focal One systems placed in India (Ruby Hall Clinic, Pune) and Argentina (Argentinian Institute of Diagnostics and Treatment, Buenos Aires), alongside additional sales in Italy and Spain. The global installed base reached 165 Focal One units by year-end, establishing a significant recurring revenue opportunity from disposables and service contracts.
U.S. Focal One procedure volumes grew 28% year-over-year, reaching the highest quarterly level to date. This growth was driven by a combination of newly launched programs and increased patient demand across existing programs, consistent across both large metropolitan statistical areas and smaller communities.
Reimbursement Tailwinds
The reimbursement landscape continues to move favorably for Focal One. The 2026 outpatient prospective payment system rule set the national facility payment average at $9,671, representing a 4.6% increase versus 2025. On the physician payment side, the total facility RVUs were set at 26.33 for the HIFU procedure — 28% to 67% higher than alternative ablative treatments for prostate cancer (搜索) under the same setting and patient conditions.
Financial Performance and 2026 Outlook
Full-year 2025 HIFU revenue reached EUR 33.1 million, up 39% from EUR 23.8 million in 2024, driven by a 59% increase in Focal One unit sales and 19% growth in treatment-driven revenue. Total company revenue was EUR 62.4 million, down 3%, as a 27% decline in noncore Distribution and ESWL segments offset HIFU gains — consistent with the company's strategy of focusing resources on the higher-margin HIFU business.
Q4 gross margin was 42.6%, down from 44.8% in the prior year period. CFO Ken Mobeck attributed the decline to "tariffs on imports of finished goods from France and an inventory reserve related to legacy parts," noting that excluding these items, underlying gross margin performance was in line with the prior year. The company has budgeted approximately $2.5 million for U.S. tariffs in 2026, with offsets expected through cost savings from the next-generation ultrasound engine.
Net loss for Q4 was EUR 8.2 million (EUR 0.22 per share), compared to EUR 1.9 million (EUR 0.05 per share) in Q4 2024, driven by a EUR 2.5 million non-cash charge related to warrants and interest expense on the European Investment Bank Tranche A drawdown, and a EUR 2 million negative currency impact.
For 2026, management guided core HIFU revenue to USD 50–54 million, representing 34%–45% growth, with combined noncore revenue expected at USD 22–26 million. The company anticipates Q4 to be the highest growth and largest dollar quarter, consistent with historical capital budget spending patterns, with Q3 representing the seasonal low point.
Clinical Indication Expansion
Beyond prostate cancer (搜索), EDAP is advancing clinical programs in endometriosis (搜索) and benign prostatic hyperplasia (搜索) (BPH). Claude University Hospital in Lyon, France, is treating endometriosis patients and hosting training programs for European specialists. For BPH, a combined Phase I/II study continues in Europe, while a new clinical trial in South America was initiated in collaboration with the Mount Sinai Health System in New York, with several patients already treated as of early March 2026.
"We are confident in our ability to deliver sustainable growth and create long-term shareholder value," Rhodes concluded, pointing to three strategic priorities for 2026: commercial execution, clinical indication expansion, and continued technology and innovation leadership.