---
schema_version: "secwatch.filing_event.v1"
accession: "0001437749-25-009978"
form_type: "8-K"
ticker: "BCDA"
cik: "0000925741"
company_name: "BioCardia, Inc."
filed_at: "2025-03-31T23:59:59+00:00"
generated_at: "2026-05-24T02:47:33.354867+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

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

## Summary
- 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.

## SEC filing metadata
- accession: 0001437749-25-009978
- form_type: 8-K
- ticker: BCDA
- cik: 0000925741
- company_name: BioCardia, Inc.
- filed_at: 2025-03-31T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/925741/000143774925009978/0001437749-25-009978-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/925741/000143774925009978/bcda20250330_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001437749-25-009978
- JSON: https://secwatch.observer/filing/0001437749-25-009978.json
- Plain text: https://secwatch.observer/filing/0001437749-25-009978.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.