Market Opportunity & Disease Burden - Heart failure affects over 6 million people in the U S [9], leading to over 1 1 million hospital discharges and over 1 3 million emergency room visits annually [11] - The annual costs associated with heart failure are expected to reach $70 billion by 2030 in the U S [11] - The U S annual net addressable market for Barostim is estimated at $2 2 billion, assuming an average selling price (ASP) of $29,000 [37] Barostim Therapy & Clinical Evidence - Barostim is presented as a neuromodulation therapy designed to improve heart failure symptoms [8] - Barostim implantation is a 60-minute procedure with a 97% freedom from major complications [46, 48] - Real-world evidence demonstrates an 85% relative reduction in hospital visits per year post-Barostim implant (average 1 92 years) compared to pre-implant (12 months) [67] Financial Performance & Guidance - Worldwide revenue for 2024 was $51 3 million, representing 31% growth [87, 88] - The gross margin for 2024 was 84% [87, 88] - The company's revenue guidance for full year 2025 is $55 0 – $58 0 million, with a gross margin of 83% – 84% and operating expenses of $95 0 – $98 0 million [90]

Core Insights - NeuroPace has completed the primary endpoint analysis of the one-year data from the NAUTILUS study, which is the first clinical study evaluating neuromodulation therapy for idiopathic generalized epilepsy (IGE) [1][7] - The study demonstrated excellent safety outcomes, meeting the primary safety endpoint with a low rate of serious adverse events related to the device [2][3] - While the primary effectiveness endpoint did not reach statistical significance in the overall population, a significant response was observed in a subgroup of patients with lower baseline seizure frequency [3][6] Study Results - The NAUTILUS study met its primary 12-week post-implant safety endpoint, confirming the favorable safety profile of the RNS System [2][3] - Clinically relevant data showed median percent seizure reduction and responder rates that were numerically robust and clinically meaningful over the first year of treatment [4][6] - The study included 100 participants, with 87 undergoing implantation of the RNS Neurostimulator across 23 epilepsy centers in the US [7] Future Plans - NeuroPace plans to submit the full dataset to the FDA and for peer-reviewed publication, engaging in discussions regarding regulatory pathways based on the data [8] - The company aims to expand access to RNS therapy and is confident in the potential for future indication expansion into IGE [5][8] - The company reaffirms its full-year 2025 financial guidance, indicating a strong base business growing over 20% year over year [9][5]