---
schema_version: "secwatch.filing_event.v1"
accession: "0001437749-26-021041"
form_type: "8-K"
ticker: "BCDA"
cik: "0000925741"
company_name: "BioCardia, Inc."
filed_at: "2026-06-18T12:00:37+00:00"
generated_at: "2026-06-18T12:05:43.855837+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# BioCardia targets Q4 2026 Japan PMDA submission for CardiAMP cell therapy; updates on US trial and pipeline

## Summary
- Japan PMDA supports potential approval of CardiAMP for ischemic HFrEF; submission planned for Q4 2026.
- Initial Japan target: 20,000 patients; prior cardiac cell therapy reimbursement at $124,000 per procedure.
- CardiAMP HF II trial enrolling in US with 4 active centers; FDA may support Premarket Approval.
- Helix delivery catheter in discussions with 8 gene/cell therapy programs; allogeneic MSC platform has 2 FDA INDs.
- Recent financing closed to fund PMDA submission, US trial enrollment, and partnership discussions.

## SEC filing metadata
- accession: 0001437749-26-021041
- form_type: 8-K
- ticker: BCDA
- cik: 0000925741
- company_name: BioCardia, Inc.
- filed_at: 2026-06-18T12:00:37+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/925741/000143774926021041/0001437749-26-021041-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/925741/000143774926021041/bcda20260617_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001437749-26-021041
- JSON: https://secwatch.observer/filing/0001437749-26-021041.json
- Plain text: https://secwatch.observer/filing/0001437749-26-021041.txt

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