---
schema_version: "secwatch.filing_event.v1"
accession: "0001437749-25-024472"
form_type: "8-K"
ticker: "BCDA"
cik: "0000925741"
company_name: "BioCardia, Inc."
filed_at: "2025-08-04T23:59:59+00:00"
generated_at: "2026-05-17T21:43:00.034697+00:00"
event_type: "regulatory"
sentiment: "neutral"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# BioCardia provides Q3/Q4 2025 timelines for FDA and PMDA submissions for CardiAMP and Helix

## Summary
- Helix DeNovo 510(k) submission to FDA planned for Q3 2025; based on >4,000 intramyocardial deliveries.
- CardiAMP Cell Therapy FDA meeting request in Q4 2025 to discuss approval pathway using clinical data from three trials.
- Japan PMDA clinical consultation for CardiAMP Cell Therapy expected mid Q4 2025; point-of-care platform already approved in Japan.
- CardiAMP HF II trial actively enrolling at five US centers including Cleveland Clinic and Emory University.

## SEC filing metadata
- accession: 0001437749-25-024472
- form_type: 8-K
- ticker: BCDA
- cik: 0000925741
- company_name: BioCardia, Inc.
- filed_at: 2025-08-04T23:59:59+00:00
- event_type: regulatory
- sentiment: neutral
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/925741/000143774925024472/0001437749-25-024472-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/925741/000143774925024472/bcda20250803_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001437749-25-024472
- JSON: https://secwatch.observer/filing/0001437749-25-024472.json
- Plain text: https://secwatch.observer/filing/0001437749-25-024472.txt

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