BioCardia Phase 3 CardiAMP-HF shows survival benefit, MACCE reduction at 2 years; primary endpoint not met

BioCardia, Inc.

Primary composite efficacy endpoint did not reach statistical significance in overall 115-patient trial.
In all treated patients: 20.9% relative risk reduction in heart death equivalents; 44.6% reduction in non-fatal MACCE.
Patients with elevated NTproBNP (50% of cohort) showed statistically significant composite of survival, MACCE, and QOL.
Treated subgroup (elevated NTproBNP) saw 47% relative risk reduction in heart death equivalents and 10.5-point MLHFQ improvement.
Company plans to discuss results with FDA and PMDA to align on regulatory pathway for this Breakthrough Therapy.

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