---
schema_version: "secwatch.filing_event.v1"
accession: "0001437749-26-012764"
form_type: "8-K"
ticker: "BCDA"
cik: "0000925741"
company_name: "BioCardia, Inc."
filed_at: "2026-04-20T23:59:59+00:00"
generated_at: "2026-05-15T05:26:04.148836+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.9
calibrated_materiality_score: 0.9
confidence: "high"
source: SEC EDGAR
---

# BioCardia announces PMDA acceptance of CardiAMP data for ischemic heart failure clearance in Japan

## Summary
- PMDA determined CardiAMP safety/efficacy data likely sufficient for market clearance in ischemic heart failure.
- Alignment reached on acceptability of US foreign clinical data, indications for use, and introduction approach.
- Company will await formal minutes from PMDA for detailed feedback and filing timeline.
- CEO Dr. Peter Altman states company on track for first minimally invasive biologic therapy approved in Japan.

## SEC filing metadata
- accession: 0001437749-26-012764
- form_type: 8-K
- ticker: BCDA
- cik: 0000925741
- company_name: BioCardia, Inc.
- filed_at: 2026-04-20T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.9
- calibrated_materiality_score: 0.9
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/925741/000143774926012764/0001437749-26-012764-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/925741/000143774926012764/bcda20260416_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001437749-26-012764
- JSON: https://secwatch.observer/filing/0001437749-26-012764.json
- Plain text: https://secwatch.observer/filing/0001437749-26-012764.txt

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