{"schema_version":"secwatch.filing_event.v1","accession":"0001641172-25-016293","form_type":"8-K","ticker":"NSPR","cik":"0001433607","company_name":"InspireMD, Inc.","filed_at":"2025-06-24T23:59:59+00:00","discovered_at":"2026-05-14T18:02:48.281471+00:00","generated_at":"2026-05-18T22:14:47.004624+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.9,"calibrated_materiality_score":0.9,"confidence":"high","headline":"InspireMD receives FDA PMA approval for CGuard Prime carotid stent system; triggers $17.9M warrant tranche","bullets":["FDA approved CGuard Prime carotid stent system on June 23, 2025 for stroke prevention in carotid artery stenosis.","Pivotal C-GUARDIANS trial (316 patients) showed lowest 30-day (0.95%) and 1-year (1.93%) major adverse event rates.","FDA approval triggers second warrant tranche; gross proceeds expected $17.9M if exercised in full.","Proceeds to fund U.S. commercial launch, new regulatory pathways, and product development.","Over 65,000 CGuard Prime implants to date; investors include Marshall Wace, OrbiMed, etc."],"urls":{"canonical":"https://secwatch.observer/filing/0001641172-25-016293","json":"https://secwatch.observer/filing/0001641172-25-016293.json","markdown":"https://secwatch.observer/filing/0001641172-25-016293.md","text":"https://secwatch.observer/filing/0001641172-25-016293.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1433607/000164117225016293/0001641172-25-016293-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1433607/000164117225016293/form8-k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-18T22:14:47.004624+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"}