---
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"
generated_at: "2026-05-17T11:09:46.731441+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.95
calibrated_materiality_score: 0.95
confidence: "high"
source: SEC EDGAR
---

# enVVeno receives FDA not-approvable letter for VenoValve PMA

## Summary
- 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.

## SEC filing metadata
- 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
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.95
- calibrated_materiality_score: 0.95
- confidence: high
- sec_items: 7.01, 9.01
- 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

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001493152-25-012181
- JSON: https://secwatch.observer/filing/0001493152-25-012181.json
- Plain text: https://secwatch.observer/filing/0001493152-25-012181.txt

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