Quarter and Full-Year Revenue
Q4 revenue of $16,000,000, up $700,000 or 4% year-over-year; full-year 2025 revenue of $56,700,000 (management described 2025 as a year of significant commercial investment).
U.S. Volume and Revenue Growth
U.S. revenue of $14,900,000 in Q4, up $600,000 or 4% year-over-year; U.S. revenue units rose to 478 from 404 (+74 units, +18%).
Improved Profitability Metrics
Gross profit of $13,800,000 for Q4, up $1,100,000 or 8% year-over-year; gross margin improved to 86% from 83% (+3 percentage points), driven by higher average selling price (ASP) and lower cost per unit from manufacturing efficiencies (ASP noted >$31,000 in 2025).
Commercial Footprint Expansion and Deep-Account Performance
Sales organization expanded to 53 territories (+10% vs. year-end 2024) and 252 active implanting centers (+13% vs. year-end 2024). Top 20% of centers had an annualized implant rate of ~19 implants in Q4 and management estimates ~300 indicated patients per top center, demonstrating substantial runway for deeper penetration.
Reimbursement Milestone — Category I CPT Code
Transition to Category I CPT codes effective 01/01/2026, eliminating automatic prior-authorization denials associated with Category III codes, improving reimbursement predictability and formalizing implanting physician payment at ~ $560 nationally — expected to reduce access friction over coming quarters.
Improved Prior Authorization Outcomes
30-day Medicare Advantage prior authorization approval rate increased to 46% in 2025 from 31% in 2024 (+15 percentage points), demonstrating meaningful progress on access even before Category I code implementation.
BENEFIT HF — Landmark Randomized Trial Initiated
Initiated BENEFIT HF trial following CMS Category B IDE coverage: randomized trial of 2,500 patients at ~100 centers (U.S. and Germany) evaluating mortality and HF decompensation; if successful, could expand addressable prevalence from ~339,000 to ~980,000 patients (tripling market to ~$30B). CMS coverage ensures Medicare reimbursement for trial patients (~$45,000 per procedure); enrollment expected to begin in 2026.
Strengthened Liquidity and Debt Flexibility
Cash and cash equivalents of $75.7M at 12/31/2025; amended term loan in January increased facility to up to $100M, borrowed an additional $10M at closing, bringing outstanding principal to $60M and providing access to further non-dilutive capital contingent on milestones. Management states at least two years of cash runway and no immediate need for additional capital.
Medical Education and Program Development
Completed over 150 local, regional and national education events in 2025 and implemented program-selling approach (focused account lists, training, field leadership changes) to drive deeper adoption and build referral workflows.