---
schema_version: "secwatch.filing_event.v1"
accession: "0001437749-25-023351"
form_type: "8-K"
ticker: "BCDA"
cik: "0000925741"
company_name: "BioCardia, Inc."
filed_at: "2025-07-24T23:59:59+00:00"
generated_at: "2026-05-18T03:01:49.864132+00:00"
event_type: "regulatory"
sentiment: "neutral"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# BioCardia submits CardiAMP cell therapy for PMDA clinical consultation in Japan

## Summary
- Submitted clinical data package including full CardiAMP HF trial results and STED to Japan's PMDA on July 24, 2025.
- Consultation seeks PMDA alignment on efficacy, safety, target patient population, and positioning in heart failure care.
- Positive PMDA feedback could enable BioCardia to submit for market approval in Japan.
- CEO expects potential post-marketing study in Japan next year if regulatory pathway is cleared.

## SEC filing metadata
- accession: 0001437749-25-023351
- form_type: 8-K
- ticker: BCDA
- cik: 0000925741
- company_name: BioCardia, Inc.
- filed_at: 2025-07-24T23:59:59+00:00
- event_type: regulatory
- sentiment: neutral
- 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/925741/000143774925023351/0001437749-25-023351-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/925741/000143774925023351/bcda20250723_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001437749-25-023351
- JSON: https://secwatch.observer/filing/0001437749-25-023351.json
- Plain text: https://secwatch.observer/filing/0001437749-25-023351.txt

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