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NeuroPace Presents Preliminary 18-Month Safety And Effectiveness Results From Ongoing NAUTILUS1 Trial Evaluating RNS System As Adjunctive Therapy For Treatment Of ASM Resistant IGE With GTC Seizures, At AES Meeting

Benzinga·12/08/2025 13:10:02
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-- 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.