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

CVRx, Inc.

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.

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