---
schema_version: "secwatch.filing_event.v1"
accession: "0001437749-25-011992"
form_type: "8-K"
ticker: "BCDA"
cik: "0000925741"
company_name: "BioCardia, Inc."
filed_at: "2025-04-15T23:59:59+00:00"
generated_at: "2026-05-23T15:15:49.194176+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# BioCardia CardiALLO heart failure trial passes DSMB review; no safety issues

## Summary
- DSMB recommends study continue as designed after 30-day safety review of 20M-cell dosing cohort.
- No treatment-emergent major adverse cardiac events or immune reactions observed.
- Company plans to enroll 39 participants in the US for Phase 1/2 CardiALLO-HF trial.
- CEO cites potential for nondilutive funding and partnering, and future pivotal trial in USA, Japan.
- High-dose arm targets patients with active inflammation, at least 2x effective dose of prior MSC studies.

## SEC filing metadata
- accession: 0001437749-25-011992
- form_type: 8-K
- ticker: BCDA
- cik: 0000925741
- company_name: BioCardia, Inc.
- filed_at: 2025-04-15T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/925741/000143774925011992/0001437749-25-011992-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/925741/000143774925011992/bcda20250415_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001437749-25-011992
- JSON: https://secwatch.observer/filing/0001437749-25-011992.json
- Plain text: https://secwatch.observer/filing/0001437749-25-011992.txt

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