---
schema_version: "secwatch.filing_event.v1"
accession: "0001437749-24-036648"
form_type: "8-K"
ticker: "BCDA"
cik: "0000925741"
company_name: "BioCardia, Inc."
filed_at: "2024-12-04T23:59:59+00:00"
generated_at: "2026-05-29T09:14:43.386739+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# BioCardia gets positive PMDA consultation; next step after final CardiAMP HF data in Q1 2025

## Summary
- Completed consultation with Japan PMDA; PMDA invited next consultation after submission of final 2-year follow-up data.
- PMDA remains open to using CardiAMP Heart Failure Trial and prior trials for registration in Japan.
- Company anticipates final data from 125-patient CardiAMP HF trial in Q1 2025.
- BCDA-01 holds FDA Breakthrough Designation; U.S. trials supported by CMS reimbursement.

## SEC filing metadata
- accession: 0001437749-24-036648
- form_type: 8-K
- ticker: BCDA
- cik: 0000925741
- company_name: BioCardia, Inc.
- filed_at: 2024-12-04T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/925741/000143774924036648/0001437749-24-036648-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/925741/000143774924036648/bcda20241204_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001437749-24-036648
- JSON: https://secwatch.observer/filing/0001437749-24-036648.json
- Plain text: https://secwatch.observer/filing/0001437749-24-036648.txt

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