Record Quarterly Revenue
Total revenue of $17.8M in Q1 2026, up 25% year-over-year from $14.3M in Q1 2025, driven by strong HIFU performance.
Robust HIFU Growth
Total HIFU revenue of $11.6M in Q1 2026 versus $6.5M in Q1 2025, a 78% year-over-year increase driven by 11 capital sales (vs. 6 prior year) and a 30% increase in treatment-driven revenue.
Surging Procedure Volumes
U.S. Focal One procedure volumes increased 53% year-over-year, reflecting growing physician adoption, expanded training and utilization at existing sites.
Improved Profitability Metrics
Gross profit rose to $8.1M from $6.0M year-over-year; gross margin improved to 45.7% from 42.0% (a 370 basis point increase). HIFU gross margin increased to 51.4% from 48.6%.
Meaningful Commercial Expansion and System Placements
11 capital sales and 10 net placements in the quarter; notable U.S. placements include UPMC cash conversion, Moffitt Cancer Center (10th Florida install), a second system at Mass General Brigham, and first deliveries/ cash sales in Mexico, France, Hungary and Cleveland Clinic London.
Clinical Evidence and Indication Expansion — HIFI‑2
Publication of HIFI-2 (largest prospective salvage study >500 patients) showing 71% of patients avoided hormone deprivation therapy at 30 months overall and 84% in a rigorously selected subgroup; supports reimbursement and guideline alignment for salvage HIFU.
Multi‑Indication Momentum (Endometriosis & BPH)
Focal One capital sales driven by demand across two indications (prostate cancer and deep infiltrating endometriosis); active endometriosis program rollouts in Europe, sponsored symposium with >400 attendees, and ongoing BPH clinical studies with Mount Sinai.
Balance Sheet Support and Corporate Transition
Company became a U.S. domestic issuer effective Jan 1, 2026 and will report in USD; subsequent to quarter end, received ~ $14M second tranche from the European Investment Bank credit facility to strengthen liquidity.
2026 Guidance Reiterated
Reaffirmed full-year 2026 guidance: core HIFU revenue $50M–$54M (implying 34%–45% growth over 2025) and combined noncore revenue $22M–$26M.