NeuroPace disclosed that the 18‑month data from its NAUTILUS 1 trial, a randomized controlled study of the RNS System in drug‑resistant idiopathic generalized epilepsy, showed a 77% median reduction in generalized tonic‑clonic seizures compared with baseline. Thirty percent of participants experienced seizure‑free periods, and the safety profile remained consistent with the device’s established record.
The 77% reduction exceeds the 50‑60% range seen in the RNS System’s original focal‑seizure trials and represents a landmark improvement for patients with idiopathic generalized epilepsy, a condition that currently lacks approved neuromodulation or surgical therapies. The data support NeuroPace’s plan to submit a PMA supplement for an IGE indication before the end of 2025, potentially opening a market of roughly 480,000 U.S. patients.
NeuroPace’s Q3 2025 financial results reflected the clinical momentum. Revenue rose 30% year‑over‑year to $27.4 million, driven by a 35% increase in RNS System sales and a 25% rise in service revenue. The company reported an EPS of –$0.11 versus consensus of –$0.20, a beat of $0.09, largely due to disciplined cost management and the absence of large one‑time charges.
CEO Joel Becker said the NAUTILUS data “strengthen our conviction that the RNS System can become a foundational adjunctive therapy for drug‑resistant IGE.” Chief Medical Officer Martha Morrell highlighted the 77% median reduction as “remarkable” and noted that it “meaningfully exceeds” the outcomes of the original focal‑seizure trial.
Analysts highlighted the strong clinical data and financial performance, noting the robust revenue growth and guidance. The company raised its full‑year 2025 revenue outlook to $27.5 million from $26.5 million, reflecting confidence in continued demand for the RNS System and the anticipated Medicare reimbursement increase effective January 2026.
NeuroPace is also advancing AI‑driven analytics to enhance seizure prediction and treatment personalization, positioning the company to capture additional value as the platform matures. The combination of clinical success, financial strength, and regulatory progress underscores the company’s trajectory toward becoming the leading neuromodulation solution for drug‑resistant epilepsy.
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