Strong Top-Line Growth
Q4 revenue of $13.2M, up 60% year-over-year (from $8.3M); Full year revenue of $45.2M, up 53% year-over-year. Company achieved its 2025 revenue growth guidance.
Improved Profitability Metrics in Q4
Q4 gross margin improved to 87% from 85% prior-year period; Q4 net operating loss narrowed to $3.3M from $7.6M; adjusted EBITDA loss improved to approximately $0.95M versus a $5.7M loss in prior-year quarter.
Year-over-Year Operating Leverage
Full-year operating loss decreased to $26.9M from $36.2M a year earlier, driven by higher revenue and margin contribution; gross profit increased by $12.9M year-over-year.
Capital Raise and Balance Sheet Strengthening
Completed an oversubscribed public offering in February raising $46M in gross proceeds (more than 2x oversubscribed) and added veteran healthcare investor Michael Stansky to the Board, improving financial flexibility to fund commercial expansion and clinical programs.
Commercial Portfolio Expansion and Product Launches
Expanded product portfolio from 2 core offerings at the start of 2025 to an expected 7 differentiated offerings in 2026; launched TriNav LV, TriGuide, TriNav FLX and TriNav XP (Q4). TriNav Advance is awaiting 510(k) clearance and anticipated initial launch in H1 2026 with broader rollout in H2 2026.
Market Opportunity and Reimbursement Wins
Reported addressable markets: liver embolization TAM ≈ $480M and broader embolization TAM ≈ $2.3B. CMS introduced HCPCS code C8004 expanding reimbursement for mapping/simulation procedures, effectively doubling reimbursable use in the radio embolization market.
Positive Clinical/Registry Early Data
PROTECT registry preliminary thyroid results: 100% technical and clinical success, no neurovascular complications, 73% reduction in thyroid size, normalization of thyroid function in 71% of participants, and transient mild discomfort in 81% (resolved within two weeks). Initiated pilot GAE registry and preparing GAE clinical trial registry.
Focused Cost and R&D Discipline
R&D spending decreased (Q4 R&D $2.6M vs ~$3.0M prior-year quarter; full-year R&D down ~$2.7M) as PERIO clinical studies were completed and internal nelitolimod development spending was substantially reduced to preserve capital.