Strong Core HIFU Revenue Growth
Full-year HIFU revenue of EUR 33.1M in 2025, up 39% versus EUR 23.8M in 2024; Q4 HIFU revenue EUR 11.7M, up 34% year-over-year.
Record System Placements and Cash Sales
Company achieved a record quarter with 15 Focal One placements (14 cash sales) in Q4 2025 and 35 Focal One sales for full-year 2025; U.S. delivered 10 cash sales in the quarter.
Procedure Volume Acceleration
U.S. Focal One procedure volumes grew 28% in Q4 2025 versus Q4 2024; treatment-driven revenue rose 19% for the full year and 22% in Q4 year-over-year.
Installed Base Expansion and Academic Penetration
Installed base grew to 165 units; Focal One adopted by 55% of NCCN member institutions and 63% penetration among SUO teaching hospitals; 10 U.S. health systems now have 2+ Focal One programs; 5 systems within global Cleveland Clinic network.
Regulatory and Technology Milestones
Received FDA clearance (Nov 20, 2025) for the latest Focal One evolution with advanced ultrasound imaging and AI-enabling capabilities; commercial launch of Focal One i in 2025 with prior price adjustment.
Favorable Reimbursement Developments
2026 outpatient facility payment average set at $9,671 (a 4.6% increase vs 2025); physician fee schedule sets total facility RVUs at 26.33 and Focal One provides physicians 28%–67% higher RVUs than alternative ablative treatments in 2026.
International Market Expansion
Q4 included 4 cash sales outside the U.S., including first-ever Focal One systems in India and Argentina and additional sales in Italy and Spain, expanding footprint in underpenetrated markets.
Improved Liquidity and Inventory Management
Inventory reduced to EUR 10.9M from EUR 13.8M at prior quarter end; cash and cash equivalents increased to EUR 17.4M from EUR 10.6M (reflecting EIB Tranche A drawdown).
Confident 2026 Guidance
Management reiterated 2026 outlook: core HIFU revenue guidance of USD 50M–54M (implying 34%–45% growth over 2025) and combined noncore revenue guidance of USD 22M–26M, driven by capital placement momentum and rising procedure volumes.
Clinical Indication Expansion & Education
Progress on BPH Phase I/II in Europe, new BPH trial in South America with Mount Sinai collaboration, endometriosis programs in Europe, and increased surgeon education via major conferences and inaugural international symposium on robotic focal therapy.