secwatch.observer — SEC 8-K summary
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Issuer:     NeuroPace Inc (NPCE)
CIK:        0001528287
Form:       8-K
Filed at:   2026-07-28T20:31:40+00:00
Accession:  0001193125-26-321083
Event type: regulatory
Sentiment:  negative
Materiality: 0.80
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1528287/000119312526321083/0001193125-26-321083-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1528287/000119312526321083/d138221d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-26-321083

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer