{"schema_version":"secwatch.filing_event.v1","accession":"0001493152-25-012181","form_type":"8-K","ticker":"NVNO","cik":"0001661053","company_name":"enVVeno Medical Corp","filed_at":"2025-08-20T23:59:59+00:00","discovered_at":"2026-05-14T18:02:44.585349+00:00","generated_at":"2026-05-17T11:09:46.731441+00:00","sec_items":["7.01","9.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.95,"calibrated_materiality_score":0.95,"confidence":"high","headline":"enVVeno receives FDA not-approvable letter for VenoValve PMA","bullets":["FDA issued not-approvable letter for VenoValve PMA, citing insufficient benefit-risk profile.","FDA raised concerns about bias without hemodynamic measurement and safety from open surgical procedure.","Company reviewing options including resubmission or appeal; continues to work with FDA.","VenoValve is lead product for severe deep chronic venous insufficiency; no approved effective treatments currently.","Company also developing non-surgical enVVe valve; expects to apply learnings for its IDE application."],"urls":{"canonical":"https://secwatch.observer/filing/0001493152-25-012181","json":"https://secwatch.observer/filing/0001493152-25-012181.json","markdown":"https://secwatch.observer/filing/0001493152-25-012181.md","text":"https://secwatch.observer/filing/0001493152-25-012181.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1661053/000149315225012181/0001493152-25-012181-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1661053/000149315225012181/form8-k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-17T11:09:46.731441+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"}