---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-23-023522"
form_type: "8-K"
ticker: "CVRX"
cik: "0001235912"
company_name: "CVRx, Inc."
filed_at: "2023-02-21T23:59:59+00:00"
generated_at: "2026-06-19T06:30:20.168154+00:00"
event_type: "other_material"
sentiment: "negative"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# CVRx BeAT-HF trial misses primary endpoint; positive secondary analyses support Barostim label expansion plan

## Summary
- Trial of 323 HFrEF patients did not reach statistical significance on primary composite endpoint of CV mortality and HF morbidity.
- Prespecified analyses favored Barostim: all-cause survival free from LVAD/transplant, Win Ratio analysis, clinical stability.
- Safety and symptomatic improvement at 6 months durable through 24 months.
- Company plans to submit totality of evidence to FDA for expanded Barostim labeling.
- Data to be presented at THT conference on March 21, 2023.

## SEC filing metadata
- accession: 0001104659-23-023522
- form_type: 8-K
- ticker: CVRX
- cik: 0001235912
- company_name: CVRx, Inc.
- filed_at: 2023-02-21T23:59:59+00:00
- event_type: other_material
- sentiment: negative
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1235912/000110465923023522/0001104659-23-023522-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1235912/000110465923023522/tm237383d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-23-023522
- JSON: https://secwatch.observer/filing/0001104659-23-023522.json
- Plain text: https://secwatch.observer/filing/0001104659-23-023522.txt

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