CVRx BeAT-HF trial: safety endpoint met, symptom improvement shown; primary endpoint not significant

CVRx, Inc.

Safety: MANCE event-free rate of 97% (p<0.001).
Symptom improvement: 6-min walk +44m at 12mo, QoL +10 pts at 24mo (p<0.001).
Primary endpoint (CV death, LVAD, transplant, HF hospitalizations) not significant (RR 0.94, p=0.82).
All-cause mortality showed 34% relative reduction favoring BAT (HR 0.66, p=0.054).
CEO plans FDA submission in coming months for expanded labeling.

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