---
schema_version: "secwatch.filing_event.v1"
accession: "0001437749-26-018670"
form_type: "8-K"
ticker: "BCDA"
cik: "0000925741"
company_name: "BioCardia, Inc."
filed_at: "2026-05-28T12:00:11+00:00"
generated_at: "2026-05-28T12:06:59.983266+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# BioCardia Japan PMDA supports CardiAMP cell therapy submission for HFrEF; submission planned Q4 2026

## Summary
- PMDA Consultation Record confirms alignment on remaining questions; positive outcomes credible.
- Estimated 20,000 of 300,000 Japanese HFrEF patients initially eligible for CardiAMP therapy.
- BioCardia plans PMDA submission in Q4 2026 with a Designated Marketing Authorization Holder.
- Clinical data showed 179 sec average exercise tolerance improvement and 82% angina reduction.
- PMDA requested additional details on GDMT compliance, revascularization ineligibility, and adverse events.

## SEC filing metadata
- accession: 0001437749-26-018670
- form_type: 8-K
- ticker: BCDA
- cik: 0000925741
- company_name: BioCardia, Inc.
- filed_at: 2026-05-28T12:00:11+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/925741/000143774926018670/0001437749-26-018670-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/925741/000143774926018670/bcda20260528_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001437749-26-018670
- JSON: https://secwatch.observer/filing/0001437749-26-018670.json
- Plain text: https://secwatch.observer/filing/0001437749-26-018670.txt

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