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MOUNTAIN VIEW, Calif. - NeuroPace, Inc. (NASDAQ: NPCE), a medical device company whose stock has surged over 134% in the past year, disclosed preliminary results from its NAUTILUS study on Tuesday, revealing a nuanced outcome for its RNS System’s use in treating idiopathic generalized epilepsy (IGE). According to InvestingPro data, the company maintains a healthy financial position with strong liquidity metrics, though current market valuation suggests the stock may be trading above its Fair Value. The study met its primary safety endpoint but failed to achieve statistical significance for its primary effectiveness endpoint across the overall population.
The NAUTILUS study, which evaluated the safety and effectiveness of the RNS System, demonstrated a low rate of serious adverse events related to the device and implant procedure. This aligns with the established safety profile of the RNS System. However, the primary effectiveness endpoint, which measured the time to a second generalized tonic-clonic seizure, did not show statistical significance when comparing the active stimulation group to the sham stimulation group within the entire study population.
Notably, a subgroup of participants with lower baseline seizure frequency exhibited a statistically significant response to the treatment. This subset represents the majority of the trial’s participants, suggesting a potential benefit of the RNS System for a substantial portion of the IGE patient population.
The study also reported preliminary data indicating that the RNS System could personalize patient treatment over time. Metrics such as median percent seizure reduction and responder rates showed improvements over the first year of treatment, with continued clinical improvement in patients who have progressed to the second year. These findings are particularly relevant given the more challenging epilepsy syndrome addressed in the study.
NeuroPace Chief Medical Officer, Dr. Martha Morrell, expressed optimism about the results, emphasizing the significant seizure reduction in a key patient subgroup and the potential for future indication expansion.
The company plans to continue discussions with the U.S. Food and Drug Administration (FDA) regarding regulatory pathways and the possibility of using the overall median seizure reduction data for a broader indication or a more targeted indication for patients with lower baseline seizure frequency.
NeuroPace reaffirmed its full-year 2025 financial guidance and remains confident in its long-term growth strategy, supported by impressive revenue growth of 22% over the last twelve months. The company will submit the complete dataset from the two-year NAUTILUS study to the FDA and for peer-reviewed publication. InvestingPro subscribers can access 13 additional key insights about NeuroPace, including detailed analysis of its financial health score and growth prospects.
The NAUTILUS study is a prospective, multicenter, randomized, single-blind, sham-stimulation controlled study that has enrolled 100 participants across 23 U.S. epilepsy centers. NeuroPace received FDA Breakthrough Device Designation status in 2021 for the RNS System’s potential use in treating IGE. With a market capitalization of approximately $580 million and four analysts recently revising earnings estimates upward, the company continues to attract investor attention. Discover more detailed insights and comprehensive analysis in the Pro Research Report, available exclusively on InvestingPro.
This article is based on a press release statement from NeuroPace, Inc.
In other recent news, NeuroPace Inc. reported first-quarter 2025 earnings, surpassing expectations with an EPS of -$0.21, better than the forecasted -$0.24. The company also achieved a revenue of $22.5 million, exceeding projections and marking a 24% year-over-year increase, driven by strong sales of its RNS System. Following these results, NeuroPace raised its full-year revenue guidance to a range of $93-97 million, reflecting anticipated growth of 16-21% from the previous year. Cantor Fitzgerald maintained an Overweight rating on NeuroPace, with a price target of $17.00, following the company’s encouraging earnings and revised guidance.
The company’s gross margin improved to 77%, up from 73.6% the previous year, highlighting enhanced financial efficiency. NeuroPace is also focusing on expanding its RNS System and discontinuing the distribution of SEEG products, which could impact short-term revenue streams but improve margins. The company plans to release the RNS 320 software in the second half of 2025, aiming to enhance its market presence. Analysts from Cantor Fitzgerald have noted the conservative nature of the updated revenue guidance, given the positive first-quarter performance and potential benefits from recent studies.
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