NeuroPace (NPCE) FDA Approvals

NeuroPace's Drug in the FDA Approval Process

This section highlights FDA-related milestones and regulatory updates for drugs developed by NeuroPace (NPCE). Over the past two years, NeuroPace has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as RNS. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

RNS System FDA Regulatory Timeline and Events

RNS System is a drug developed by NeuroPace for the following indication: Drug-resistant idiopathic generalized epilepsy. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Provided Update - April 27,2026

• Drug: RNS System
• Announced Date: April 27, 2026
• Indication: Drug-resistant idiopathic generalized epilepsy

NeuroPace, Inc. 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.

NeuroPace announced publication in Neurology of 3-year results from its RNS System Post-Approval Study (PAS). The study showed an 82% median seizure reduction in adults with drug-resistant focal epilepsy. The PAS enrolled 324 implanted patients across 32 U.S. centers and is the largest prospective neuromodulation study in this patient group. These 3-year data support a strong, durable clinical benefit of the RNS System in a broad, real-world focal epilepsy population.

At the 2026 American Academy of Neurology Annual Meeting, NeuroPace also presented 12- and 18-month data from the ongoing NAUTILUS trial, the first randomized controlled trial of neuromodulation in drug-resistant idiopathic generalized epilepsy (IGE). Together, the PAS publication and NAUTILUS results add to a growing body of high-quality evidence that reinforces the RNS System’s differentiated role across both focal and generalized epilepsy and highlights NeuroPace’s clinical leadership in responsive neurostimulation.

Application Submitted - December 17,2025

PMA Supplement Approval

• Drug: RNS System
• Announced Date: December 17, 2025
• Indication: Drug-resistant idiopathic generalized epilepsy

NeuroPace, Inc 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.

NeuroPace, Inc. has filed a Premarket Approval Supplement (PMA‑S) with the U.S. Food and Drug Administration to expand the labeled use of its RNS® System to include patients with antiseizure‑medication (ASM)‑resistant idiopathic generalized epilepsy (IGE) who experience generalized tonic‑clonic (GTC) seizures. The request seeks formal approval to treat this specific, hard‑to‑treat group with responsive neurostimulation.

The submission is supported by preliminary 18‑month results from the NAUTILUS trial, which reported a 77% median reduction in GTC seizures and a favorable safety profile among highly refractory patients. These data suggest the RNS System may offer significant seizure control where medications have failed.

Under FDA guidance, PMA supplements are typically reviewed within about 180 days, though review times can vary. NeuroPace says the filing is an important step to make responsive neuromodulation available to more patients with drug‑resistant IGE.

Data - April 8,2025

• Drug: RNS System
• Announced Date: April 8, 2025
• Indication: Drug-resistant idiopathic generalized epilepsy

NeuroPace, Inc. announced three-year effectiveness data from the Post-Approval Study (PAS) of the RNS® System, which showed an 82% median reduction in seizures in adults treated with brain-responsive stimulation for drug-resistant focal epilepsy (DRE).1

NeuroPace, Inc. recently announced exciting three-year data from its Post-Approval Study (PAS) of the RNS® System, the largest FDA-reviewed neuromodulation study in drug-resistant focal epilepsy. The study, which enrolled 324 patients, showed a median seizure reduction of 82% at three years in adults treated with brain-responsive stimulation. In addition, 42% of patients achieved seizure freedom for at least six months, while rapid improvements were seen with a 62% median reduction in seizures at six months. These results highlight the continued effectiveness and safety of the RNS System, reinforcing its role as the only FDA-approved device that provides personalized, real-time brain-responsive neurostimulation for drug-resistant epilepsy. Presenting these findings at the American Academy of Neurology Annual Meeting, NeuroPace’s study adds valuable evidence supporting the use of targeted neuromodulation to improve the quality of life for patients with drug-resistant focal epilepsy.

Oral presentation - February 3,2025

• Drug: RNS System
• Announced Date: February 3, 2025
• Indication: Drug-resistant idiopathic generalized epilepsy

NeuroPace, Inc announced that an abstract featuring data from the Post-approval Study of the RNS System has been selected for an oral presentation at the upcoming American Academy of Neurology (AAN) 2025 Annual Meeting, which is being held April 5th – 9th in San Diego.

NeuroPace, Inc. recently announced that an abstract featuring data from the Post-approval Study of the RNS System has been selected for an oral presentation at the American Academy of Neurology (AAN) 2025 Annual Meeting. This abstract focuses on evaluating the effectiveness of the RNS System in treating focal epilepsy.

Dr. Dawn Eliashiv, a respected professor of neurology and co-director at the UCLA Seizure Disorders Center, will present the study during session S20, titled "Multicenter Post-approval Study of the RNS System in Focal Epilepsy." The presentation is scheduled for Monday, April 7th at 5:06 PM PT at the meeting held in San Diego from April 5th through April 9th. This presentation underlines the potential of the RNS System to provide personalized treatment and improved outcomes for people living with epilepsy.

Enrollment Update - December 3,2024

• Drug: RNS System
• Announced Date: December 3, 2024
• Indication: Drug-resistant idiopathic generalized epilepsy

NeuroPace, Inc. announced completion of enrollment and implant procedures in its feasibility investigational device exemption (IDE) study of the RNS® System for the treatment of Lennox-Gastaut Syndrome (LGS), a devastating form of childhood-onset epilepsy characterized by cognitive dysfunction and frequent generalized onset seizures that often lead to injury.

NeuroPace, Inc. announced that it has completed enrollment and the implant procedures in its feasibility investigational device exemption (IDE) study using the RNS® System for treating Lennox-Gastaut Syndrome (LGS). LGS is a severe form of childhood-onset epilepsy that leads to cognitive challenges and frequent generalized seizures, which often cause injury. The study enrolled 20 patients aged 12 and older with drug-resistant generalized seizures to evaluate whether brain-responsive neurostimulation can help manage LGS. The research is supported by a $9.3 million grant from the National Institutes of Health through the BRAIN Initiative. Although the RNS System is already known for its safety and effectiveness in treating focal onset seizures in adults, this study aims to explore its potential to improve treatment outcomes for patients with LGS. The team now looks forward to gathering valuable data that may guide future research and treatment options for LGS.