Core Insights - NeuroPace, Inc. (NPCE) is evolving from a device-centric model to incorporating software and workflow tools aimed at enhancing clinician capacity and expanding the eligible patient pool over time [1] Group 1: AI and Software Integration - NeuroPace is integrating artificial intelligence features as a workflow enhancement rather than a separate revenue stream, with the goal of reducing physician review time and increasing patient management efficiency without additional costs [2] - The company plans to migrate its clinician platform to the cloud to facilitate rapid deployment of software capabilities, which can enhance adoption and maintain consistent updates across various sites [3] Group 2: Seizure ID and Remote Care - Seizure ID is positioned as a near-term AI catalyst, submitted for FDA approval in Q4 2025, with expectations for clearance in the first half of 2026 [4] - The Seizure ID feature aims to alleviate the data-review burden in epilepsy practices, thereby expediting clinical decisions and follow-ups, and will be integrated into the RNS platform at no additional subscription fee [5] - Remote Care is targeted for regulatory submission in 2026, designed to enhance telehealth programming and follow-up efficiency, which can help clinics manage more patients without increasing operational costs [6][7] Group 3: Expansion and Market Strategy - The largest demand-expansion lever is the idiopathic generalized epilepsy indication, with a premarket approval supplement filed on December 15, 2025, currently under FDA review [8][9] - The company is focusing on expanding its reach beyond Level 4 comprehensive epilepsy centers through Project CARE, which includes targeted investments and enhanced nurse navigator support to improve access and throughput [12] - Successful execution of community site onboarding is critical, requiring sustained training and development of referral networks to ensure consistent care quality [13] Group 4: Future Monitoring and Expectations - Key performance indicators for 2026 include evidence of growth in prescribers and patients, regulatory progress on Seizure ID, and plans for Remote Care submission [15] - Early signs of coverage and training readiness for the idiopathic generalized epilepsy review will be crucial for advancing the approval process and expanding payer coverage [10]

Financial Data and Key Metrics Changes - The company reported fourth quarter revenue of $26.6 million, representing a 24% year-over-year growth compared to $21.5 million in the prior year quarter [5][22] - RNS System revenue was $22.4 million, up 26% year-over-year, reflecting strong performance in the core business [6][22] - Gross margin improved to over 77%, up approximately 200 basis points year-over-year, driven by manufacturing efficiencies [9][24] - Adjusted EBITDA was positive at $900,000 in the fourth quarter, marking a $1.9 million improvement compared to the prior year quarter [28] Business Line Data and Key Metrics Changes - The majority of revenue growth continues to come from Level 4 centers, with RNS growth in the second half of 2025 at 29% [8] - Service revenue tied to data collaborations totaled approximately $890,000 in the fourth quarter [22] - Revenue from DIXI Medical was approximately $3 million, representing a decline of 4% compared to the fourth quarter of 2024 [22] Market Data and Key Metrics Changes - The company is focused on expanding access to RNS therapy through community pathways and referral pathways, which are contributing to growth [6][8] - The adult focal epilepsy market remains a significant opportunity, with ongoing efforts to deepen adoption and utilization [6][39] Company Strategy and Development Direction - The company aims to grow a minimum of 20% in its core RNS business with the current adult focal epilepsy indication [9] - Strategic investments are being made in the commercial organization, including sales representative additions and nurse navigator resources [11][20] - The company is pursuing an expanded indication for the RNS System in idiopathic generalized epilepsy (IGE) and has submitted a PMA supplement to the FDA [12][13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the long-term growth trajectory and the potential for a transformational 2026 [10][20] - The company is optimistic about the upcoming approval for IGE and the associated market opportunities [41][55] - Management highlighted the importance of ongoing investments in product development and clinical programs to enhance the RNS System's capabilities [42] Other Important Information - The company plans to report DIXI-related financial results as discontinued operations starting in Q1 2026 [30][31] - Full year 2026 revenue guidance is reiterated at $98 million-$100 million, excluding contributions from DIXI [32] Q&A Session Summary Question: Can you provide details on the timeline from approval to revenue collection for the generalized opportunity? - Management indicated that extending coverage in the private payer community is crucial and that preparations are already underway [46] Question: What is the magnitude of pricing impact on RNS growth in the fourth quarter? - Management noted consistent mid-single digit pricing increases annually, with no significant changes in Q4 [61] Question: What are the current dynamics regarding capacity across implanting centers? - Management stated that there is sufficient capacity in the channel for prescribers and that nurse navigators are being utilized to streamline patient flow [70][72] Question: Can you elaborate on the Seizure ID opportunity and its implementation? - Seizure ID will be part of the RNS System offering, aimed at improving clinician efficiency without additional costs [79]

Financial Performance & Growth - NeuroPace's 2024 revenue reached $79.9 million, demonstrating a 22% year-over-year growth[12] - Q3 2025 revenue was $27.4 million, a 30% increase year-over-year[15] - Gross margin in Q3 2025 was 77.4%, a 417 bps increase year-over-year[15] - FY 2025 revenue guidance is projected to be between $97 million and $98 million, representing an 18%-23% growth[64] RNS System & Clinical Data - The RNS System has been implanted in over 6,000 patients[12] - The RNS System demonstrated a 75% median seizure reduction at 9 years in the original FDA study results[28] - The FDA post-approval study results showed an 82% median seizure reduction at 3+ years[28] Market Opportunity & Expansion - The annual target market opportunity is estimated to be over $3.5 billion[12] - The company is targeting a $55 billion+ total addressable market (TAM) for drug-resistant epilepsy (DRE)[41] - There are approximately 1.2 million people in the U S with drug-resistant epilepsy[18]