---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-23-129004"
form_type: "8-K"
ticker: "CVRX"
cik: "0001235912"
company_name: "CVRx, Inc."
filed_at: "2023-12-26T23:59:59+00:00"
generated_at: "2026-06-07T07:14:08.667510+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# CVRx receives FDA approval for expanded Barostim labeling; annual market opportunity increases to $2.2B

## Summary
- FDA approved revised Instructions For Use for Barostim incorporating long-term BeAT-HF trial data (NYHA Class III/II, EF ≤35%, NT-proBNP <1600 pg/ml).
- Clinical Summary includes 6/12/24-month data, win ratio, all-cause mortality; primary safety endpoint met, but CV death+HF hospitalization endpoint not met.
- U.S. annual market opportunity revised to $2.2B (76,000 new patients) from $1.4B (55,000), increases of ~60% and 38%.
- CEO Nadim Yared highlighted validation of long-term results and ability to share data with physicians and patients.

## SEC filing metadata
- accession: 0001104659-23-129004
- form_type: 8-K
- ticker: CVRX
- cik: 0001235912
- company_name: CVRx, Inc.
- filed_at: 2023-12-26T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1235912/000110465923129004/0001104659-23-129004-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1235912/000110465923129004/tm2333686d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-23-129004
- JSON: https://secwatch.observer/filing/0001104659-23-129004.json
- Plain text: https://secwatch.observer/filing/0001104659-23-129004.txt

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