NeuroPace FDA PMA Supplement for IGE indication not approvable; additional data requested

NeuroPace Inc

FDA indicated PMA Supplement for RNS System in idiopathic generalized epilepsy (IGE) is not approvable in current form; additional clinical evidence from NAUTILUS trial requested.
NeuroPace will submit a Submission Issue Request (SIR) and amend submission with supplemental data; FDA invited continued dialogue.
NAUTILUS 24-month data showed 100% median GTC seizure reduction in evaluable patients; 77% reduction at 18 months.
Company's 2026 guidance does not include any contribution from IGE indication; Q2 earnings call on Aug 11, 2026.
Management to host conference call at 4:30pm ET to discuss FDA communication.

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