{"schema_version":"secwatch.filing_event.v1","accession":"0001493152-24-015752","form_type":"8-K","ticker":"NVNO","cik":"0001661053","company_name":"enVVeno Medical Corp","filed_at":"2024-04-24T23:59:59+00:00","discovered_at":"2026-05-14T18:03:19.475722+00:00","generated_at":"2026-06-03T09:42:10.147549+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: 72% of VenoValve patients show clinically meaningful benefit; FDA filing on track for Q4 2024","bullets":["72% of SAVVE trial patients achieved ≥3-point rVCSS improvement at a weighted average of 11 months post-surgery.","Overall average rVCSS improvement of 8.46 points for meaningful-benefit cohort; 9.29 points at two-year milestone.","94% of patients showed clinical improvement (≥1 point rVCSS) at a weighted average of 11 months post-implant.","Company expects to complete one-year data collection by September 2024 and file PMA for FDA approval in Q4 2024.","Cash and investments of $46.4M at Dec 31, 2023 expected to fund operations through FDA decision and end of 2025."],"urls":{"canonical":"https://secwatch.observer/filing/0001493152-24-015752","json":"https://secwatch.observer/filing/0001493152-24-015752.json","markdown":"https://secwatch.observer/filing/0001493152-24-015752.md","text":"https://secwatch.observer/filing/0001493152-24-015752.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1661053/000149315224015752/0001493152-24-015752-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1661053/000149315224015752/form8-k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-03T09:42:10.147549+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"}