{"schema_version":"secwatch.filing_event.v1","accession":"0001493152-23-038979","form_type":"8-K","ticker":"NSPR","cik":"0001433607","company_name":"InspireMD, Inc.","filed_at":"2023-11-01T23:59:59+00:00","discovered_at":"2026-05-14T18:03:29.064877+00:00","generated_at":"2026-06-09T02:19:36.553124+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"InspireMD reports positive 30-day C-GUARDIANS trial results: 0.95% DSMI rate in 316 patients","bullets":["DSMI (death, stroke, MI) rate of 0.95% through 30 days post-procedure in 316 high-risk carotid artery stenosis patients.","Trial enrolled from July 2021 to June 2023 across 24 US and EU sites; single-arm, prospective IDE study.","Primary endpoint composite includes 30-day DSMI plus ipsilateral stroke from day 31 to 365; success if upper 95% CI < 11.6%.","Primary endpoint results expected H2 2024; potential FDA premarket approval application targeted for H1 2025."],"urls":{"canonical":"https://secwatch.observer/filing/0001493152-23-038979","json":"https://secwatch.observer/filing/0001493152-23-038979.json","markdown":"https://secwatch.observer/filing/0001493152-23-038979.md","text":"https://secwatch.observer/filing/0001493152-23-038979.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1433607/000149315223038979/0001493152-23-038979-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1433607/000149315223038979/form8-k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-09T02:19:36.553124+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"}