NeuroPace Submits Premarket Approval Supplement Application To FDA For Expansion Of Labeled Indication For RNS System

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.