---
schema_version: "secwatch.filing_event.v1"
accession: "0001493152-23-041594"
form_type: "8-K"
ticker: "NVNO"
cik: "0001661053"
company_name: "enVVeno Medical Corp"
filed_at: "2023-11-16T23:59:59+00:00"
generated_at: "2026-06-08T01:14:20.335221+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# enVVeno Medical reports positive preliminary safety data from VenoValve pivotal trial; 8% MAE rate, no deaths or PEs

## Summary
- Preliminary device-related MAE rate 8% for fully enrolled 75-patient SAVVE trial; no deaths or pulmonary embolisms.
- Six DVTs occurred; three adjudicated as device-related mild, three pending, expected similar results.
- Higher-than-expected procedure-related bleeding in contiguous sub-group, all moderate, attributed to anticoagulation.
- Company expects to present topline efficacy data in Q2 2024 and file PMA application in Q4 2024.
- enVVeno also developing enVVe transcatheter valve; pivotal trial expected to begin Q4 2024.

## SEC filing metadata
- accession: 0001493152-23-041594
- form_type: 8-K
- ticker: NVNO
- cik: 0001661053
- company_name: enVVeno Medical Corp
- filed_at: 2023-11-16T23:59:59+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/1661053/000149315223041594/0001493152-23-041594-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1661053/000149315223041594/form8-k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001493152-23-041594
- JSON: https://secwatch.observer/filing/0001493152-23-041594.json
- Plain text: https://secwatch.observer/filing/0001493152-23-041594.txt

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