---
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"
generated_at: "2026-05-15T02:14:00.080034+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# enVVeno receives FDA IDE approval for pivotal study of non-surgical venous valve; $25M cash

## Summary
- 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.

## SEC filing metadata
- 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
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 8.01, 2.02, 2.01, 7.01, 9.01
- 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

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001493152-26-019485
- JSON: https://secwatch.observer/filing/0001493152-26-019485.json
- Plain text: https://secwatch.observer/filing/0001493152-26-019485.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.