earnings
confidence high
sentiment negative
materiality 0.65
BioCardia FY2023 net loss $11.6M; CardiAMP HF trial misses primary endpoint but subgroup shows benefit
BioCardia, Inc.
- Revenue $0.5M (down from $1.4M); net loss $11.6M; cash $1.1M at year-end; financing provides runway into Q2 2024.
- CardiAMP HF trial missed primary endpoint; interim data: 37% RR reduction in heart death equivalents overall.
- In NTproBNP-elevated subgroup (59% of patients): 86.2% RR reduction in heart death equivalents (2.9% vs 21.1%).
- Confirmatory Phase III CardiAMP HF II trial approved by FDA with >90% power; Medicare reimbursement certified.
- Morph DNA steerable sheath family expects FDA approval Q3 2024; two additional biotherapeutic delivery partnerships anticipated.