---
schema_version: "secwatch.filing_event.v1"
accession: "0001437749-26-031011"
form_type: "8-K"
ticker: "BCDA"
cik: "0000925741"
company_name: "BioCardia, Inc."
filed_at: "2026-09-23T13:15:10+00:00"
generated_at: "2026-09-23T13:16:15.392653+00:00"
event_type: "regulatory"
sentiment: "neutral"
materiality_score: 0.5
calibrated_materiality_score: 0.5
confidence: "high"
source: SEC EDGAR
---

# BioCardia updates FDA Helix pre-submission and PMDA CardiAMP HF Shonin timing

## Summary
- PMDA Shonin pre-market submission targeted for Q4 2026; possible market clearance by Q4 2027.
- FDA Helix follow-on De Novo pre-submission intended this quarter; FDA feedback within 70 calendar days.
- CardiAMP HF II trial actively enrolling at four U.S. centers; CBER indicates study may support a PMA.
- Company provided detailed responses to PMDA consultation questions; working on QMS and Foreign Manufacturer Registration.

## SEC filing metadata
- accession: 0001437749-26-031011
- form_type: 8-K
- ticker: BCDA
- cik: 0000925741
- company_name: BioCardia, Inc.
- filed_at: 2026-09-23T13:15:10+00:00
- event_type: regulatory
- sentiment: neutral
- materiality_score: 0.5
- calibrated_materiality_score: 0.5
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/925741/000143774926031011/0001437749-26-031011-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/925741/000143774926031011/bcda20260923_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001437749-26-031011
- JSON: https://secwatch.observer/filing/0001437749-26-031011.json
- Plain text: https://secwatch.observer/filing/0001437749-26-031011.txt

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