---
schema_version: "secwatch.filing_event.v1"
accession: "0001437749-26-019653"
form_type: "8-K"
ticker: "BCDA"
cik: "0000925741"
company_name: "BioCardia, Inc."
filed_at: "2026-06-05T12:00:10+00:00"
generated_at: "2026-06-05T12:05:37.423586+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# BioCardia: FDA confirms CardiAMP HF II trial may support PMA for HFrEF therapy

## Summary
- FDA CBER Q-Sub meeting minutes confirm ongoing CardiAMP HF II trial may support Premarket Approval (PMA) for market clearance.
- PMA is the most rigorous FDA device marketing application; previously FDA typically required two trials for large indications like HFrEF.
- FDA had previously determined CardiAMP Cell Therapy System safe, enabling CMS reimbursement in trial.
- Over 1 million U.S. ischemic HFrEF patients could potentially benefit from CardiAMP Cell Therapy.
- Company plans to complete U.S. trial for PMA and submit for regulatory approval in Japan with a post-marketing study.

## SEC filing metadata
- accession: 0001437749-26-019653
- form_type: 8-K
- ticker: BCDA
- cik: 0000925741
- company_name: BioCardia, Inc.
- filed_at: 2026-06-05T12:00:10+00:00
- event_type: regulatory
- 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/925741/000143774926019653/0001437749-26-019653-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/925741/000143774926019653/bcda20260605d_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001437749-26-019653
- JSON: https://secwatch.observer/filing/0001437749-26-019653.json
- Plain text: https://secwatch.observer/filing/0001437749-26-019653.txt

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