{"schema_version":"secwatch.filing_event.v1","accession":"0001493152-26-051453","form_type":"8-K","ticker":"NSPR","cik":"0001433607","company_name":"InspireMD, Inc.","filed_at":"2026-11-12T21:45:54+00:00","discovered_at":"2026-11-12T21:47:01.462585+00:00","generated_at":"2026-11-12T21:47:07.551549+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"InspireMD wins FDA approval for CGuard Prime TCAR stent, doubling US addressable market","bullets":["FDA approved the PMA supplement for the CGuard Prime TransCarotid Stent System (80 cm delivery) for TCAR procedures used with an embolic protection system specified in labeling.","Approval adds access to more than 35,000 annual US TCAR procedures, doubling CGuard Prime's TAM; TCAR plus CAS total ~75,000 US carotid stenting procedures yearly per company estimates.","CGUARDIANS II pivotal trial: 50 patients across 11 US sites; 100% acute device success with zero death, stroke, MI or stent thrombosis at 30 days.","Commercial entry can proceed independently of the investigational SwitchGuard NPS, which is still enrolling in the CGUARDIANS III pivotal trial.","CEO Marvin Slosman called it a 'strong near-term growth driver' and said InspireMD is the first company with both CAS and TCAR delivery options."],"urls":{"canonical":"https://secwatch.observer/filing/0001493152-26-051453","json":"https://secwatch.observer/filing/0001493152-26-051453.json","markdown":"https://secwatch.observer/filing/0001493152-26-051453.md","text":"https://secwatch.observer/filing/0001493152-26-051453.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1433607/000149315226051453/0001493152-26-051453-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1433607/000149315226051453/form8-k.htm"},"model":{"generated_by":"deepseek-v4.1-flash:cloud@v2","generated_at":"2026-11-12T21:47:07.551549+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"}