Page 1

NeuroPace Receives FDA Guidance on PMA Supplement for Indication Expansion into Idiopathic Generalized Epilepsy July 28 , 2026 -- Company received communication from FDA indicating that the PMA Supplement for idiopathic generalized epilepsy is not approvable in its current form and that additional clinical evidence from the NAUTILUS trial and literature supporting the submission has been requested -- __ -FDA has invited continued dialogue , and NeuroPace will be submitting a Submission Issue Request and intends to continue working with FDA on a path for approval of the submission -- Management will host a conference call to discuss this communication from the FDA at 4:30 pm E.T./1:30pm P.T. -- MOUNTAIN VIEW , Calif .-- ( BUSINESS WIRE ) -- 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 . " 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 . "