other material
confidence high
sentiment negative
materiality 0.85
CVRx BeAT-HF trial misses primary endpoint; positive secondary analyses support Barostim label expansion plan
CVRx, Inc.
- 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.