NeuroPace, Inc. (NASDAQ:NPCE), a medical device company focused on transforming the lives of people living with epilepsy, today provided an update on the U.S. Food and Drug Administration review of the Company’s Premarket Approval Panel Track Supplement seeking to expand the labeled indication for the RNS® System to include patients with antiseizure medication-resistant idiopathic generalized epilepsy (IGE).

NeuroPace has received a communication from FDA indicating that the PMA Supplement is not approvable in its current form. Following receipt of the communication, NeuroPace met with FDA to discuss the Agency’s feedback and the additional information needed to place the PMA Supplement in approvable form. At the recommendation of FDA and based on that discussion, the Company will be submitting a Submission Issue Request ("SIR") to further discuss its planned approach with FDA and intends to amend its submission with supplemental information, including additional data and context regarding the patient populations evaluated in the NAUTILUS clinical trial.