Why Is NeuroPace Stock Falling After Epilepsy Treatment Study Data?

Core Insights - NeuroPace, Inc. released preliminary one-year results from the NAUTILUS study, which evaluated the safety and effectiveness of the RNS System for drug-resistant idiopathic generalized epilepsy (IGE) [1] - The study met its primary safety endpoint, showing a low rate of serious adverse events related to the device and implant procedure [1][2] - However, the primary effectiveness endpoint did not reach statistical significance for the overall study population, although a significant response was observed in a subgroup with lower baseline seizure frequency [2][3] Study Results - The study demonstrated clinically meaningful improvements in median percent seizure reduction, responder rates, and seizure-free days over the first year of treatment, continuing into the second year for those who progressed [4] - The company plans to engage with the FDA to discuss regulatory pathways based on the data, potentially focusing on patients with lower baseline seizure frequency [5] Financial Performance - NeuroPace reported a 24% increase in sales to $22.5 million in Q1 2025, with RNS System revenue growing by 29% excluding revenue from the NAUTILUS study [6] - The company raised its fiscal year 2025 sales guidance from $92 million-$96 million to $93 million-$97 million, compared to the consensus of $93.64 million [7] - Increased sales of the RNS System were the primary driver of revenue growth, alongside continued revenue from SEEG products [6][7] Stock Performance - NPCE stock experienced a decline of 33.90%, trading at $11.68 at the last check [7]