{"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","discovered_at":"2026-07-28T20:33:00.709138+00:00","generated_at":"2026-07-28T20:33:37.969142+00:00","sec_items":["7.01","9.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"NeuroPace FDA PMA Supplement for IGE indication not approvable; additional data requested","bullets":["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."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-26-321083","json":"https://secwatch.observer/filing/0001193125-26-321083.json","markdown":"https://secwatch.observer/filing/0001193125-26-321083.md","text":"https://secwatch.observer/filing/0001193125-26-321083.txt","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"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-07-28T20:33:37.969142+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}