{"schema_version":"secwatch.filing_event.v1","accession":"0001493152-26-019485","form_type":"8-K","ticker":"NVNO","cik":"0001661053","company_name":"enVVeno Medical Corp","filed_at":"2026-04-29T23:59:59+00:00","discovered_at":"2026-05-14T18:02:32.688196+00:00","generated_at":"2026-05-15T02:14:00.080034+00:00","sec_items":["8.01","2.02","2.01","7.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"enVVeno receives FDA IDE approval for pivotal study of non-surgical venous valve; $25M cash","bullets":["FDA grants first-ever IDE for a U.S. pivotal study of a non-surgical replacement venous valve (enVVe System).","TAVVE study: stage 1 enrolls 10 patients; stage 2 enrolls 220 patients (165 valve, 55 control) at up to 40 US sites.","Company reports ~$25M cash/investments as of March 31, 2026, funding operations into Q3 2027.","Addresses ~3 million U.S. patients with severe deep CVI; no effective current treatments for valvular incompetence.","enVVe features: 13Fr delivery profile, porcine pericardium leaflet, no general anesthesia needed."],"urls":{"canonical":"https://secwatch.observer/filing/0001493152-26-019485","json":"https://secwatch.observer/filing/0001493152-26-019485.json","markdown":"https://secwatch.observer/filing/0001493152-26-019485.md","text":"https://secwatch.observer/filing/0001493152-26-019485.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1661053/000149315226019485/0001493152-26-019485-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1661053/000149315226019485/form8-k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-15T02:14:00.080034+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"}