{"schema_version":"secwatch.filing_event.v1","accession":"0001493152-24-036293","form_type":"8-K","ticker":"NSPR","cik":"0001433607","company_name":"InspireMD, Inc.","filed_at":"2024-09-16T23:59:59+00:00","discovered_at":"2026-05-14T18:03:13.046332+00:00","generated_at":"2026-05-31T04:33:34.483744+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"InspireMD submits PMA to FDA for CGuard Prime carotid stent; U.S. launch targeted H1 2025","bullets":["PMA submission on Sept 16, 2024, seeks FDA marketing approval for CGuard Prime carotid stent system.","Application based on C-GUARDIANS pivotal trial showing 1.95% primary endpoint major adverse event rate through 12 months.","Trial enrolled 316 patients across 24 U.S. and European sites; lowest event rate reported for any carotid stent pivotal trial.","U.S. commercial launch anticipated in first half of 2025, subject to FDA approval.","CEO Marvin Slosman cites best-in-class clinical outcomes and building U.S. commercial infrastructure."],"urls":{"canonical":"https://secwatch.observer/filing/0001493152-24-036293","json":"https://secwatch.observer/filing/0001493152-24-036293.json","markdown":"https://secwatch.observer/filing/0001493152-24-036293.md","text":"https://secwatch.observer/filing/0001493152-24-036293.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1433607/000149315224036293/0001493152-24-036293-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1433607/000149315224036293/form8-k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-31T04:33:34.483744+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"}