NeuroPace Announces Preliminary Results from One-Year Data in NAUTILUS Study

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]