NeuroPace Files PMA Supplement to FDA Seeking Expanded RNS® System Indication for Idiopathic Generalized Epilepsy

Key Terms

premarket approval supplement regulatory

A premarket approval supplement is a regulatory submission seeking permission to change a medical device that already has FDA premarket approval, similar to asking a regulator for permission to alter a certified product before selling the new version. For investors, it matters because the supplement triggers a review that can affect how quickly a revised device reaches the market, add development or compliance costs, and change future sales or competitive positioning.

pma-s regulatory

A PMA-S (PMA supplement) is a regulatory filing to amend an already approved Premarket Approval for a medical device, seeking permission for changes such as new materials, design tweaks, manufacturing processes, or new uses. For investors, it matters because a granted supplement can let a company expand or improve a product without a full new review, while a denial or long review can delay revenue and add costs; think of it like applying for a building permit change before renovating a finished property.

u.s. food and drug administration regulatory

The U.S. Food and Drug Administration is the federal agency that evaluates and enforces safety, effectiveness and labeling standards for medicines, medical devices, vaccines, food and related products before they reach consumers. For investors it matters because FDA approvals, warnings or recalls determine whether a product can be sold, how quickly it reaches the market and how costly compliance will be—changes that directly affect a company’s revenue, costs and stock value.

idiopathic generalized epilepsy medical

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.

generalized tonic-clonic medical

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.

antiseizure-medication medical

Antiseizure medication is a drug used to prevent or reduce the frequency and severity of seizures by calming overactive brain activity. For investors, these drugs matter because they represent medical treatments with steady patient demand, potential for long-term revenue from chronic use, and regulatory and patent factors that affect market exclusivity and profitability—think of them as maintenance products that keep a chronic condition under control.

breakthrough device designation regulatory

A breakthrough device designation is a regulatory program that gives promising medical devices for serious or life‑threatening conditions priority support and faster review from a health authority (e.g., the U.S. FDA). Think of it as a “fast lane” or VIP pass through development and review: it can shorten time to market, lower regulatory uncertainty, and boost a company’s commercial prospects — but it is not an approval by itself.

neuromodulation medical

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.

-- Submission supported by positive preliminary 18-month NAUTILUS data in patients with drug-resistant idiopathic generalized epilepsy (IGE) and generalized tonic-clonic (GTC) seizures --

MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)-- NeuroPace, Inc. (Nasdaq: NPCE), a medical device company focused on transforming the lives of people living with epilepsy, today announced that it has filed a Premarket Approval Supplement (PMA-S) application to the U.S. Food and Drug Administration (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.

The PMA-S is supported by positive preliminary results from the NAUTILUS trial, which demonstrated robust 77% median GTC seizure reduction and a favorable safety profile in this highly refractory patient population at 18 months of therapy. The RNS System has been granted Breakthrough Device Designation for this IGE indication, reflecting the significant unmet clinical need and the potential for the therapy to provide more effective treatment than existing options. Under current FDA guidelines, PMA supplements are typically reviewed within approximately 180 days, although actual review times may vary.

“Filing the PMA supplement for idiopathic generalized epilepsy is an important milestone in our strategy to make responsive neuromodulation available to more patients who need it,” said Joel Becker, President and Chief Executive Officer of NeuroPace. “Unlike focal epilepsy, patients with drug-resistant IGE have no approved alternative treatment options, and the NAUTILUS data show that RNS therapy can deliver robust and clinically meaningful seizure reductions with an excellent safety profile in a population that currently has no approved neuromodulation options. Breakthrough Device Designation has facilitated constructive engagement with FDA, and we look forward to working closely with the Agency as it reviews our substantive clinical evidence.”

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; NeuroPace’s expectations and beliefs that the results from the final data lock at 24 months of therapy will be in line with those observed in the preliminary data at 18 months of therapy; 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; 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: estimates regarding the duration, timing and scope of the FDA’s review of the NAUTILUS PMA-S submission; projections about the impact of IGE indication expansion on the availability of the RNS System to potential new patients; 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; 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.

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Investor Contact:

Scott Schaper

Head of Investor Relations

sschaper@neuropace.com

investors@neuropace.com

Source: NeuroPace, Inc.