---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-26-321083"
form_type: "8-K"
ticker: "NPCE"
cik: "0001528287"
company_name: "NeuroPace Inc"
filed_at: "2026-07-28T20:31:40+00:00"
generated_at: "2026-07-28T20:33:37.969142+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

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

## Summary
- 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.

## SEC filing metadata
- accession: 0001193125-26-321083
- form_type: 8-K
- ticker: NPCE
- cik: 0001528287
- company_name: NeuroPace Inc
- filed_at: 2026-07-28T20:31:40+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1528287/000119312526321083/0001193125-26-321083-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1528287/000119312526321083/d138221d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-26-321083
- JSON: https://secwatch.observer/filing/0001193125-26-321083.json
- Plain text: https://secwatch.observer/filing/0001193125-26-321083.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.