NeuroPace
NASDAQ-listed neurotechnology company developing closed-loop responsive neurostimulation for drug-resistant epilepsy. The RNS System is the only FDA-approved closed-loop brain-implant therapy for refractory focal epilepsy, with a PMA supplement filed for the IGE expansion indication.
Overview
NeuroPace is a publicly-listed neurotechnology company (NASDAQ: NPCE) developing closed-loop responsive neurostimulation for drug-resistant epilepsy. The company was founded in 1997 by Rebecca L. Kuhn and Frank M. Fischer and is headquartered in Mountain View, California. Joel Becker has served as President and CEO since July 2023.
The RNS System
NeuroPace’s commercial product is the RNS System, an implantable closed-loop brain stimulator that continuously monitors brain activity and delivers responsive stimulation only when it detects abnormal electrical patterns that indicate an imminent seizure. The system is currently FDA-approved for adults with focal drug-resistant epilepsy and is the only closed-loop brain-implant therapy approved by the FDA for this indication.
NAUTILUS expansion indication
NeuroPace is pursuing FDA approval for an expanded indication into idiopathic generalised epilepsy (IGE) through the NAUTILUS pivotal trial. The trial’s 18-month follow-up data, presented at the American Academy of Neurology annual meeting in April 2026 and revisited on the Q1 2026 earnings call on 12 May 2026, showed a 77% median reduction in generalised tonic-clonic seizures, more than 30% reduction in injury events, and 44% reduction in benzodiazepine rescue medication usage. The FDA exercised a 180-day clock pause on the NAUTILUS PMA supplement during the agency’s mid-cycle review, with NeuroPace expecting a midyear 2026 determination. The device holds FDA Breakthrough Device Designation for the IGE indication.
2026 commercial trajectory
NeuroPace reported Q1 2026 total revenue of $22.1 million, with $21.7 million from the core RNS System (up 19.5% year-on-year from Q1 2025). The company raised full-year 2026 revenue guidance to $99-101 million, implying 21-23% growth for the core RNS business. NeuroPace’s Q1 2026 print landed in the same window as Inspire Medical’s Q1 guidance cut, with the two companies on opposite sides of the CMS WISeR prior-authorization bifurcation that took effect on 1 January 2026.
Strategic position
NeuroPace sits at the closed-loop end of the broader neuromodulation market, with revenue trajectory increasingly diverging from open-loop and pre-closed-loop incumbents. The company’s combined RNS System revenue traction, NAUTILUS pivotal-stage clinical evidence, and Breakthrough Device-supported FDA pathway position it as the most operationally validated closed-loop neurostimulation company at commercial stage.