Quarterly Revenue and RNS System Growth
Q1 2026 revenue of $22.1M (or $22.0M excluding DIXI), driven by RNS system revenue of $21.7M. Management highlighted underlying RNS momentum and the CFO reported excluding DIXI non-GAAP revenue of $22.0M, a 20.1% year-over-year increase versus $18.3M in Q1 2025; RNS system revenue grew ~19.5% year-over-year (from $18.2M to $21.7M).
Raised Full-Year 2026 Guidance
NeuroPace raised full-year 2026 revenue guidance to $99M–$101M (up from $98M–$100M). The midpoint increased by ~$1M, driven by improved visibility into service revenue (~$0.5M) and core RNS outlook (~$0.5M); management expects underlying RNS growth of 21%–23% (core adult focal indication) and continues to exclude IGE contribution from guidance.
Improving Adjusted Profitability Metrics
Non-GAAP loss from operations improved to -$3.3M in Q1 2026 versus -$4.1M a year ago; adjusted EBITDA loss improved to -$3.3M (Q1 2026) from -$4.1M (Q1 2025). Full-year adjusted EBITDA outlook improved to a loss of -$8.5M to -$9.5M (previously -$9M to -$10M).
Strong Operating Leverage
Q1 non-GAAP operating expenses were $21.5M versus $19.4M a year ago (~+10%), materially below revenue growth (~20%), demonstrating operating leverage as sales and commercial investments scale.
High Gross Margins and Pricing Tailwind
Q1 non-GAAP gross margin of 82.5% versus 83.6% in the prior year quarter (prior year included a ~120 bps one-time inventory benefit). Management noted underlying gross margin expansion year-over-year driven by favorable pricing conversion and expects full-year adjusted gross margin of 81.5%–82.5%.
Clinical Evidence Strength and Regulatory Progress
Positive NAUTILUS 18-month results presented at AAN: 77% median reduction in generalized tonic-clonic seizures, reductions in absence and myoclonic seizures exceeded GTC reductions, ~30% decline in injury events, and 44% lower benzodiazepine rescue use versus baseline. Company completed FDA mid-cycle (Day 100) meeting for the IGE PMA supplement, responded to follow-up questions promptly, and believes a midyear determination remains on track; breakthrough device designation facilitating interactions.
Published Long-Term Outcomes
3-year post-approval study in drug-resistant focal epilepsy published in Neurology (late April), demonstrating an 82% median seizure reduction, reinforcing long-term durability of RNS outcomes from a prospective FDA-monitored study.
Product and AI Roadmap Progress
ECOG Assistant (AI-enabled seizure identification) showing encouraging internal validation; submission paired with cloud clinician platform migration and expected approval in 2026. Multimodal foundational AI model leveraging >26M intracranial iEEG recordings and ~8,000 patient implants is ~1/3 through training with early internal performance exceeding prior algorithmic approaches.
Commercial and Market Development Momentum
Company reached all-time highs in active prescribers, accounts, and patient pipeline; management reported accelerating additions to the pipeline, continued penetration in Level 4 epilepsy centers, expanding community referral channels, targeted hires and sales incentive changes to improve funnel velocity, and service revenue of $314K from data collaborations.