---
schema_version: "secwatch.filing_event.v1"
accession: "0001493152-24-015752"
form_type: "8-K"
ticker: "NVNO"
cik: "0001661053"
company_name: "enVVeno Medical Corp"
filed_at: "2024-04-24T23:59:59+00:00"
generated_at: "2026-06-03T09:42:10.147549+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# enVVeno: 72% of VenoValve patients show clinically meaningful benefit; FDA filing on track for Q4 2024

## Summary
- 72% of SAVVE trial patients achieved ≥3-point rVCSS improvement at a weighted average of 11 months post-surgery.
- Overall average rVCSS improvement of 8.46 points for meaningful-benefit cohort; 9.29 points at two-year milestone.
- 94% of patients showed clinical improvement (≥1 point rVCSS) at a weighted average of 11 months post-implant.
- Company expects to complete one-year data collection by September 2024 and file PMA for FDA approval in Q4 2024.
- Cash and investments of $46.4M at Dec 31, 2023 expected to fund operations through FDA decision and end of 2025.

## SEC filing metadata
- accession: 0001493152-24-015752
- form_type: 8-K
- ticker: NVNO
- cik: 0001661053
- company_name: enVVeno Medical Corp
- filed_at: 2024-04-24T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1661053/000149315224015752/0001493152-24-015752-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1661053/000149315224015752/form8-k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001493152-24-015752
- JSON: https://secwatch.observer/filing/0001493152-24-015752.json
- Plain text: https://secwatch.observer/filing/0001493152-24-015752.txt

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