NeuroPace Announces Positive 18-Month NAUTILUS Trial Results in Idiopathic Generalized Epilepsy
-- First randomized controlled trial of neuromodulation in drug-resistant idiopathic generalized epilepsy (IGE) --
-- 18-month data show a 77% median reduction in generalized tonic-clonic (GTC) seizures, supporting forthcoming PMA supplement submission --
-- Remains on track to submit NAUTILUS PMA Supplement to FDA for IGE indication expansion by year-end 2025 --
NeuroPace, Inc. (NASDAQ:NPCE), a medical device company focused on transforming the lives of people living with epilepsy, announced the presentation at the American Epilepsy Society (AES) meeting of preliminary 18-month safety and effectiveness results from its ongoing NAUTILUS1 trial evaluating the RNS® System as an adjunctive therapy for the treatment of antiseizure medication (ASM) resistant idiopathic generalized epilepsy (IGE) with generalized tonic-clonic (GTC) seizures.
At 18 months of therapy, patients treated with the RNS System experienced a 77% median reduction in GTC seizures compared with baseline (p<0.001). Reductions in GTCs and days without any generalized seizure were rapid and sustained over time. The benefits of treatment were strongly endorsed by physicians and patients with Clinical Global Impression of Change exceeding 80% in both groups at 18 months, underscoring the clinical meaningfulness of the observed benefit.
"Approximately 30% of people with idiopathic generalized epilepsy continue to have disabling generalized tonic-clonic seizures despite multiple antiseizure medications, and there are no approved neuromodulation or surgical options for these patients," said Martha Morrell, MD, Chief Medical Officer of NeuroPace. "Seeing a 77% median reduction in GTCs at 18 months of therapy in this refractory population is remarkable. Notably, the 18-month median seizure reduction in the studied IGE population meaningfully exceeds what was observed in our original pivotal focal trial, despite the differences in patient populations and seizure types. The improvements we observe in seizure frequency are mirrored by how patients and their physicians rate overall change, which tells us this therapy is having a meaningful impact on daily life."
Safety results were consistent with the well-established RNS System profile and demonstrated highly significant (p=<0.0001) outcomes.
"These data strengthen our conviction that the RNS System has the potential to become a foundational adjunctive therapy for drug-resistant idiopathic generalized epilepsy," said Joel Becker, President and Chief Executive Officer of NeuroPace. "The preliminary 18-month NAUTILUS results further demonstrate that the RNS System has provided evidence of a compelling risk benefit profile that could result in the first neuromodulation therapy indicated for idiopathic generalized epilepsy."
About NeuroPace, Inc.
Based in Mountain View, Calif., NeuroPace is a medical device company focused on transforming the lives of people living with epilepsy by reducing or eliminating the occurrence of debilitating seizures. Its novel and differentiated RNS System is the first and only commercially available, brain-responsive platform that delivers personalized, real-time treatment at the seizure source. This platform can drive a better standard of care for patients living with drug-resistant epilepsy and has the potential to offer a more personalized solution and improved outcomes to the large population of patients suffering from other brain disorders.
Forward Looking Statements
This press release may contain forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "aims," "anticipates," "believes," "could," "estimates," "expects," "forecasts," "goal," "intends," "may," "plans," "possible," "potential," "seeks," "will" and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. NeuroPace may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Forward-looking statements in this press release include, but are not limited to, statements regarding: NeuroPace's expectations, forecasts and beliefs with respect to potential indication expansion for its RNS System and its software, technology and other product development efforts; the sufficiency of the NAUTILUS clinical trial data to support the FDA's approval of the RNS System for the treatment of drug-resistant, idiopathic generalized epilepsy; increasing access to and adoption of RNS therapy as the standard of care in drug-resistant epilepsy. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various factors, including: actual operating results may differ significantly from any guidance provided; uncertainties related to market acceptance and adoption of NeuroPace's RNS System; risks related to regulatory compliance and expectations for regulatory submissions and approvals to expand the market for NeuroPace's RNS System, including risks related to the NAUTILUS clinical trial; risks related to NeuroPace's reliance on contractors and other third parties, including single-source suppliers and vendors; and other important factors. These and other risks and uncertainties include those described more fully in the section titled "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" and elsewhere in NeuroPace's public filings with the U.S. Securities and Exchange Commission (SEC), including its Quarterly Report on Form 10-Q for the quarter ended September 30, 2025, filed with the SEC on November 4, 2025, as well as any other reports that it may file with the SEC in the future. Forward-looking statements contained in this announcement are based on information available to NeuroPace as of the date hereof. NeuroPace undertakes no obligation to update such information except as required under applicable law. These forward-looking statements should not be relied upon as representing NeuroPace's views as of any date subsequent to the date of this press release and should not be relied upon as a prediction of future events. In light of the foregoing, investors are urged not to rely on any forward-looking statement in reaching any conclusion or making any investment decision about any securities of NeuroPace.
1 For additional information and disclosures related to NAUTILUS trial, please visit www.neuropace.com/providers/clinical-trials/nautilus
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