---
schema_version: "secwatch.filing_event.v1"
accession: "0001437749-26-030023"
form_type: "8-K"
ticker: "BCDA"
cik: "0000925741"
company_name: "BioCardia, Inc."
filed_at: "2026-09-10T12:30:13+00:00"
generated_at: "2026-09-10T12:35:20.917964+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# BioCardia targets Q4 2026 Shonin submission for CardiAMP; FDA supports PMA path

## Summary
- Targets Q4 2026 Shonin pre-market submission to Japan's PMDA for CardiAMP cell therapy for ischemic heart failure.
- FDA meeting minutes confirm ongoing CardiAMP HF II pivotal trial may support Premarket Approval (PMA) in the U.S.
- Plans to submit follow-on De Novo pre-submission for Helix transendocardial delivery catheter in Q3 2026.
- Advancing Heart3D Fusion Imaging with partner CART-Tech toward potential FDA 510(k) submission.
- CEO Peter Altman to present at H.C. Wainwright 28th Annual Global Investment Conference, Sept 14-16, 2026.

## SEC filing metadata
- accession: 0001437749-26-030023
- form_type: 8-K
- ticker: BCDA
- cik: 0000925741
- company_name: BioCardia, Inc.
- filed_at: 2026-09-10T12:30:13+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.6
- calibrated_materiality_score: 0.6
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/925741/000143774926030023/0001437749-26-030023-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/925741/000143774926030023/bcda20260908_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001437749-26-030023
- JSON: https://secwatch.observer/filing/0001437749-26-030023.json
- Plain text: https://secwatch.observer/filing/0001437749-26-030023.txt

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