---
schema_version: "secwatch.filing_event.v1"
accession: "0001493152-25-022440"
form_type: "8-K"
ticker: "NVNO"
cik: "0001661053"
company_name: "enVVeno Medical Corp"
filed_at: "2025-11-14T23:59:59+00:00"
generated_at: "2026-05-16T19:52:28.183507+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# enVVeno loses FDA appeal for VenoValve PMA; shifts focus to enVVe device

## Summary
- Unfavorable FDA appeal upheld not-approvable letter for VenoValve (received Aug 19, 2025).
- Company to redirect resources to next-gen transcatheter valve enVVe, ready for human testing.
- Cash and investments totaled $31.5M at Q3 end; quarterly burn $4-5M funds operations into 2027.
- No approved treatments exist for severe deep CVI from valvular incompetence, affecting up to 3.5M US patients.

## SEC filing metadata
- accession: 0001493152-25-022440
- form_type: 8-K
- ticker: NVNO
- cik: 0001661053
- company_name: enVVeno Medical Corp
- filed_at: 2025-11-14T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1661053/000149315225022440/0001493152-25-022440-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1661053/000149315225022440/form8-k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001493152-25-022440
- JSON: https://secwatch.observer/filing/0001493152-25-022440.json
- Plain text: https://secwatch.observer/filing/0001493152-25-022440.txt

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