{"schema_version":"secwatch.filing_event.v1","accession":"0001493152-23-041594","form_type":"8-K","ticker":"NVNO","cik":"0001661053","company_name":"enVVeno Medical Corp","filed_at":"2023-11-16T23:59:59+00:00","discovered_at":"2026-05-14T18:03:29.977428+00:00","generated_at":"2026-06-08T01:14:20.335221+00:00","sec_items":["7.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"enVVeno Medical reports positive preliminary safety data from VenoValve pivotal trial; 8% MAE rate, no deaths or PEs","bullets":["Preliminary device-related MAE rate 8% for fully enrolled 75-patient SAVVE trial; no deaths or pulmonary embolisms.","Six DVTs occurred; three adjudicated as device-related mild, three pending, expected similar results.","Higher-than-expected procedure-related bleeding in contiguous sub-group, all moderate, attributed to anticoagulation.","Company expects to present topline efficacy data in Q2 2024 and file PMA application in Q4 2024.","enVVeno also developing enVVe transcatheter valve; pivotal trial expected to begin Q4 2024."],"urls":{"canonical":"https://secwatch.observer/filing/0001493152-23-041594","json":"https://secwatch.observer/filing/0001493152-23-041594.json","markdown":"https://secwatch.observer/filing/0001493152-23-041594.md","text":"https://secwatch.observer/filing/0001493152-23-041594.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1661053/000149315223041594/0001493152-23-041594-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1661053/000149315223041594/form8-k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-08T01:14:20.335221+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"}