---
schema_version: "secwatch.filing_event.v1"
accession: "0001437749-26-031665"
form_type: "8-K"
ticker: "BCDA"
cik: "0000925741"
company_name: "BioCardia, Inc."
filed_at: "2026-10-01T13:15:18+00:00"
generated_at: "2026-10-12T14:18:38.999012+00:00"
event_type: "regulatory"
sentiment: "neutral"
materiality_score: 0.4
calibrated_materiality_score: 0.4
confidence: "high"
source: SEC EDGAR
---

# BioCardia files revised De Novo pre-submission to FDA for Helix Catheter approval

## Summary
- Revised Pre-Submission to FDA CDRH under Q-Submission program covers the Helix Catheter for therapeutic and diagnostic agent delivery to the heart.
- In May 2026 FDA agreed there are two pathways for Helix marketing clearance and raised no concerns on safety data, device performance, or agent compatibility.
- FDA confirmed and accepted the meeting minutes in August 2026; revised submission incorporates FDA CDRH advice from those minutes.
- Helix data spans 15 clinical trials and nearly 500 patients; FDA targets acceptance/refusal review in 15 days and feedback or meeting within 70 days.
- Independent clearance could expand partnering with developers of cell, gene and protein therapeutics needing targeted heart delivery.

## SEC filing metadata
- accession: 0001437749-26-031665
- form_type: 8-K
- ticker: BCDA
- cik: 0000925741
- company_name: BioCardia, Inc.
- filed_at: 2026-10-01T13:15:18+00:00
- event_type: regulatory
- sentiment: neutral
- materiality_score: 0.4
- calibrated_materiality_score: 0.4
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/925741/000143774926031665/0001437749-26-031665-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/925741/000143774926031665/bcda20261001_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001437749-26-031665
- JSON: https://secwatch.observer/filing/0001437749-26-031665.json
- Plain text: https://secwatch.observer/filing/0001437749-26-031665.txt

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