{"schema_version":"secwatch.filing_event.v1","accession":"0001493152-24-008950","form_type":"8-K","ticker":"NVNO","cik":"0001661053","company_name":"enVVeno Medical Corp","filed_at":"2024-03-06T23:59:59+00:00","discovered_at":"2026-05-14T18:03:25.014210+00:00","generated_at":"2026-06-05T02:43:10.545401+00:00","sec_items":["7.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.95,"calibrated_materiality_score":0.95,"confidence":"high","headline":"enVVeno Medical Reports Positive VenoValve Pivotal Trial Data; 97% of Patients Show Clinical Improvement at Six Months","bullets":["97% of VenoValve study patients showed clinical improvement at six months measured by revised Venous Clinical Severity Score (rVCSS).","74% of patients achieved clinically meaningful benefit (rVCSS improvement of 3 or more points).","Average rVCSS improvement per patient was 8 points, over 2.5 times the threshold for clinically meaningful benefit.","Company on track to file VenoValve FDA approval application (PMA) in Q4 2024.","Data presented at 2024 American Venous Forum Annual Meeting in Tampa, Florida on March 6, 2024."],"urls":{"canonical":"https://secwatch.observer/filing/0001493152-24-008950","json":"https://secwatch.observer/filing/0001493152-24-008950.json","markdown":"https://secwatch.observer/filing/0001493152-24-008950.md","text":"https://secwatch.observer/filing/0001493152-24-008950.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1661053/000149315224008950/0001493152-24-008950-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1661053/000149315224008950/form8-k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-05T02:43:10.545401+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"}