---
schema_version: "secwatch.filing_event.v1"
accession: "0001437749-25-037910"
form_type: "8-K"
ticker: "BCDA"
cik: "0000925741"
company_name: "BioCardia, Inc."
filed_at: "2025-12-16T23:59:59+00:00"
generated_at: "2026-05-16T13:09:18.008328+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# BioCardia advances CardiAMP Cell Therapy to formal PMDA consultation for HFrEF in Japan

## Summary
- Completed third preliminary clinical consultation with Japan's PMDA for CardiAMP Cell Therapy (HFrEF).
- PMDA will allow BioCardia to proceed to formal clinical consultation; potential path to regulatory filing.
- Data from three completed Phase I-III trials show improved survival, reduced MACE, and better heart function vs control.
- CEO Peter Altman notes therapy offers a new mechanism of microvascular repair for ischemic HFrEF patients.

## SEC filing metadata
- accession: 0001437749-25-037910
- form_type: 8-K
- ticker: BCDA
- cik: 0000925741
- company_name: BioCardia, Inc.
- filed_at: 2025-12-16T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.6
- calibrated_materiality_score: 0.6
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/925741/000143774925037910/0001437749-25-037910-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/925741/000143774925037910/bcda20251216_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001437749-25-037910
- JSON: https://secwatch.observer/filing/0001437749-25-037910.json
- Plain text: https://secwatch.observer/filing/0001437749-25-037910.txt

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