-NeuroPace, Inc. (Nasdaq: NPCE), a medical device company focused on transforming the lives of people living with epilepsy, 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.

“We received communication from FDA on the PMA-S target due date indicating that our submission was not approvable in its current form due to questions that remained under review. Having reviewed FDA’s written communications and having had subsequent discussions with the Agency, we believe there is a path for approval of the submission. Our interactions are now focused on providing the information needed to answer FDA’s remaining requests. While we are disappointed with not receiving an initial approval, we were encouraged by our subsequent discussion with the Agency, and importantly, their interest in engaging interactively, their request for additional information to address certain questions, and their willingness to work collaboratively to bring the RNS indication expansion for drug-resistant IGE patients to market,” said Joel Becker, President and Chief Executive Officer of NeuroPace. “We are working closely with FDA beginning the day following the receipt of their letter, this week with the review team and with a subsequent SIR meeting. We will provide additional updates as appropriate.”

The PMA Supplement is supported by data from NeuroPace’s NAUTILUS study, the first randomized controlled trial of neuromodulation in drug-resistant IGE. The 18-month NAUTILUS results were published in Epilepsia in June 2026 in an article titled “Responsive stimulation of the thalamus for idiopathic generalized epilepsy: Results of the randomized controlled NAUTILUS trial through 18 months.” The publication provides Level 1 evidence supporting responsive thalamic stimulation as a potential treatment approach for patients with drug-resistant IGE and provides an important peer-reviewed foundation for the dataset reviewed by FDA.

At 18 months, patients treated with the RNS System experienced a 77% median reduction in GTC seizures compared with baseline, and 40% of patients experienced GTC seizure freedom at that timepoint. The study also demonstrated rapid reductions in other generalized seizure types, including absence and myoclonic seizures. Additionally, more than 90% of patients reported improvement on the Patient Global Impression of Change, and 80% of physicians reported improvement on the Clinical Global Impression of Improvement at 18 months.

Further, per request of the FDA during the review process, the Company provided 24-month data from its NAUTILUS study to supplement the aforementioned 18-month data. Patients continued to improve with stimulation; among the evaluable participants with completed 24-month post-implant follow-up, those who received stimulation for 23 of 24 months post-implant achieved a median percent reduction in GTC seizures of 100% compared with baseline, underscoring the potential for responsive neuromodulation to deliver meaningful and durable benefit in a patient population with no approved neuromodulation or surgical treatment options.

“Patients with drug-resistant idiopathic generalized epilepsy live with substantial life limitations, and risks of physical injury and death imposed by generalized seizures, especially generalized tonic clonic seizures,” said Martha Morrell, MD, Chief Medical Officer of NeuroPace. “In the NAUTILUS trial, the average patient had lived with uncontrolled generalized seizures for more than 18 years and was taking nearly 4 antiseizure medications a day. These patients are not candidates for epilepsy surgery, and there are no approved neuromodulation devices. Their only choice is to continue with the status quo. Patients with medically uncontrolled IGE are motivated to access better treatments, as demonstrated by the rapid rate of enrollment in the NAUTILUS study. We remain encouraged by the data gathered through 24 months and are working collaboratively with FDA to provide the information needed to support approval of this indication expansion.”

As previously communicated, NeuroPace’s management guidance does not include any contribution from the expanded IGE indication. Management will provide full second quarter 2026 financial results and any updates to full year outlook on its second quarter 2026 earnings conference call scheduled for August 11, 2026.