NeuroPace Highlights Expanding Clinical Evidence Leadership with Published 3-Year Post-Approval Study (PAS) Results in Neurology and NAUTILUS Presentation at AAN 2026
NeuroPace Highlights Expanding Clinical Evidence Leadership with Published 3-Year Post-Approval Study (PAS) Results in Neurology and NAUTILUS Presentation at AAN 2026
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post-approval studymedical
A post-approval study is a research program regulators require or companies choose to run after a drug or medical device is already approved and sold, to track real-world safety, longer-term effectiveness, or performance in broader patient groups. Investors care because results can change product labels, sales forecasts, or trigger additional costs and restrictions—think of it as a warranty-era check that can alter a product’s market value and legal risk.
randomized controlled trialmedical
A randomized controlled trial is a research method that tests the effects of a new idea or treatment by randomly dividing participants into two groups: one that receives the treatment and one that does not. This approach helps ensure that the results are fair and unbiased, providing clear evidence about whether the treatment actually works. Investors value such trials because they offer reliable information that can influence decision-making and reduce uncertainty.
idiopathic generalized epilepsymedical
Idiopathic generalized epilepsy is a form of epilepsy where recurring seizures arise across both sides of the brain without an identifiable structural cause, often linked to inherited factors. Think of it like a wiring issue that affects an entire house rather than a single appliance; seizures can take several typical forms (brief staring spells, muscle jerks, or full convulsions). For investors, it matters because prevalence, treatment options, ongoing drug and device trials, and regulatory progress drive demand, reimbursement, and commercial opportunity in the neurological and pharmaceutical markets.
neuromodulationmedical
Neuromodulation is the use of devices or targeted treatments to change how nerves or brain circuits send signals, much like adjusting the volume or tuning on an audio system to alter what you hear. For investors, it matters because these therapies can treat chronic conditions (pain, movement disorders, depression) where existing medicines fall short, creating potential markets, regulatory milestones, and durable revenue streams if technologies prove safe and effective.
generalized tonic-clonicmedical
A generalized tonic-clonic seizure is a sudden episode where a person loses consciousness and their whole body first becomes stiff and then jerks rhythmically, reflecting abnormal electrical activity across both sides of the brain; it can last from seconds to a few minutes. Investors track this because it is a common, serious clinical outcome used as a safety and efficacy measure in drug and device trials and influences regulatory decisions, labeling, and market opportunity—think of it like a system-wide power surge that defines the need and safety profile for medical products.
benzodiazepinemedical
A benzodiazepine is a type of prescription drug that calms the brain and body to relieve anxiety, help sleep, stop seizures or relax muscles — think of it as a temporary dimmer switch for overactive nerve signals. For investors, benzodiazepines matter because their demand, safety profile, regulatory restrictions, generic competition and litigation risk can directly affect drug makers’ sales, development plans and healthcare costs.
clinical global impression of changemedical
A clinician-rated scale that captures a doctor’s overall judgment of how much a patient’s condition has improved or worsened since the start of treatment. Investors care because it provides a simple, comparable snapshot of treatment effect used in trials and regulatory reviews—like a coach’s overall rating of a player’s progress—which can influence approval chances, market expectations, and commercial prospects.
—Published 3-year Post-Approval Study results show 82% median seizure reduction in drug-resistant focal epilepsy —
— American Academy of Neurology (AAN) presentation featured 12- and 18-month NAUTILUS data, the first randomized controlled trial of neuromodulation in drug-resistant idiopathic generalized epilepsy (IGE) —
—Growing body of high-quality clinical evidence reinforces the RNS System’s differentiated position across focal and generalized epilepsy —
MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)--
NeuroPace, Inc. (Nasdaq: NPCE), a medical device company focused on transforming the lives of people living with drug resistant epilepsy, today announced a major milestone in its clinical evidence program with the publication of 3-year results from the RNS® System Post-Approval Study (PAS) in Neurology, alongside the Company’s recent presentation of 12- and 18-month data from its ongoing NAUTILUS trial at the 2026 American Academy of Neurology Annual Meeting.
Together, these milestones underscore the breadth and strength of NeuroPace’s clinical evidence leadership in epilepsy. The published PAS results reinforce the RNS System’s well-established value in drug-resistant focal epilepsy, while the NAUTILUS presentation highlights continued progress in expanding the reach of responsive neurostimulation into idiopathic generalized epilepsy (IGE).
The RNS System PAS is the largest FDA-reviewed prospective neuromodulation study for focal drug-resistant epilepsy, enrolling 324 implanted patients across 32 U.S. centers. Published 3-year results demonstrated an 82% median seizure reduction, providing further evidence of the RNS System’s strong and durable clinical benefit in a broad real-world adult focal epilepsy population.
In addition, NeuroPace recently presented 12- and 18-month data from its ongoing NAUTILUS study evaluating the RNS System as an adjunctive therapy for the treatment of antiseizure medication-resistant idiopathic generalized epilepsy with generalized tonic-clonic (GTC) seizures. 18-month results showed a 77% median reduction in GTC seizures compared with baseline, with rapid and sustained reductions over time. Reductions were also observed across other seizure types, including absence and myoclonic seizures, with reductions in both seizure types exceeding those observed for GTC seizures. The data also showed that injury events declined by approximately 30% following treatment and that the use of a benzodiazepine as a rescue medication for a GTC seizure were 44% lower compared with baseline (p<0.001). 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.
“The publication of the 3-year PAS results in Neurology represents an important milestone for the epilepsy community and adds to the robust body of evidence supporting the RNS System in drug-resistant focal epilepsy,” said Martha Morrell, MD, Chief Medical Officer of NeuroPace. “At the same time, the NAUTILUS dataset continues to mature, and we remain encouraged by the durability of the treatment effect and safety profile observed to date in idiopathic generalized epilepsy. These data highlight the broad potential of responsive neurostimulation to address meaningful unmet needs across epilepsy populations.”1
“NeuroPace continues to lead the field in developing high-quality clinical evidence for neuromodulation in epilepsy,” said Joel Becker, President and Chief Executive Officer of NeuroPace. “The publication of our 3-year PAS results in Neurology and the presentation of NAUTILUS data at AAN reflect the depth of our evidence base and our commitment to advancing the RNS System across both established and emerging patient populations.”
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 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 Annual Report on Form 10-K for the year ended December 31, 2025, filed with the SEC on March 3, 2026, 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 The Premarket Approval Supplement (PMA-S) application to the FDA seeking to expand the labeled indication for its RNS System to include patients with antiseizure-medication (ASM) resistant idiopathic generalized epilepsy (IGE) with generalized tonic-clonic seizures was submitted to the FDA in December of 2025 and is currently under review.
