---
schema_version: "secwatch.filing_event.v1"
accession: "0001437749-25-029547"
form_type: "8-K"
ticker: "BCDA"
cik: "0000925741"
company_name: "BioCardia, Inc."
filed_at: "2025-09-22T23:59:59+00:00"
generated_at: "2026-05-17T06:03:46.866136+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# BioCardia gets positive PMDA preliminary consultation on CardiAMP HF trial for Japan approval

## Summary
- Positive preliminary PMDA consultation on CardiAMP Heart Failure Trial data; formal clinical consultation expected by year-end 2025.
- PMDA requested clarifications on composite endpoints, statistical power, NTproBNP subgroup risk-benefit, Japan target patient count, and US development status.
- BioCardia completing responses to PMDA questions; 178 ischemic HF patients across three trials under review.
- Focus on autologous cell therapy for patients with few therapeutic options, per CEO Peter Altman.

## SEC filing metadata
- accession: 0001437749-25-029547
- form_type: 8-K
- ticker: BCDA
- cik: 0000925741
- company_name: BioCardia, Inc.
- filed_at: 2025-09-22T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/925741/000143774925029547/0001437749-25-029547-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/925741/000143774925029547/bcda20250919c_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001437749-25-029547
- JSON: https://secwatch.observer/filing/0001437749-25-029547.json
- Plain text: https://secwatch.observer/filing/0001437749-25-029547.txt

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