NeuroPace Inc Reports Positive Safety Data in Nautilus Study

By Philip Seaworth • Tuesday, May 27 10:25 • Permanent Link

NeuroPace, Inc. has announced preliminary results from the one-year data in the Nautilus study, evaluating the safety and effectiveness of the RNS system for treating individuals with drug-resistant idiopathic generalized epilepsy (IGE).

The study successfully met its primary 12-week post-implant safety endpoint, demonstrating a low rate of serious adverse events related to the device and implant procedure. However, the primary effectiveness endpoint did not reach statistical significance in the overall study population.

Despite this, the data did show a clinically meaningful and highly statistically significant response in the primary effectiveness endpoint within a subgroup of patients with lower baseline frequency of generalized tonic-clonic seizures, which represented the majority of trial participants.

Preliminary data illustrates the overall value of the RNS system to individualize patient treatment over time, showing more favorable rates of median seizure reduction than observed in the company’s randomized controlled trial supporting its current indication in focal epilepsy.

In terms of financial guidance, the company has reaffirmed its previously issued full-year 2025 financial guidance.

The Nautilus study is a prospective, multicenter, randomized, single-blind, sham-stimulation controlled study that enrolled 100 participants, with 87 undergoing implantation of the RNS neurostimulator and leads across 23 epilepsy centers within the US.

NeuroPace plans to submit the full dataset to the FDA and for peer-reviewed publication and will engage with the FDA to discuss regulatory pathways based on the data.

The company's CEO expressed confidence in their long-term growth strategy and excitement about the opportunities ahead, noting a strong base business growing over 20% year over year.

NeuroPace will host a conference call to discuss these results, and interested parties will be able to access a live and archived webcast of the event. As a result of these announcements, the company's shares have moved -1.06% on the market, and are now trading at a price of $17.68. Check out the company's full 8-K submission here.

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