---
schema_version: "secwatch.filing_event.v1"
accession: "0001437749-26-003582"
form_type: "8-K"
ticker: "BCDA"
cik: "0000925741"
company_name: "BioCardia, Inc."
filed_at: "2026-02-10T23:59:59+00:00"
generated_at: "2026-05-16T03:46:56.166356+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# BioCardia files FDA Pre-Submission for Helix transendocardial catheter approval

## Summary
- Completed Pre-Submission (Q-Submission) to FDA for Helix catheter for intramyocardial delivery.
- Data from 15 well-controlled clinical trials supports safety and effectiveness.
- Pre-Submission under CardiAMP Cell Therapy System FDA Breakthrough Designation.
- Goal to align with FDA on regulatory pathway and timing within next 45 days.
- CEO states Helix aims to be first approved transendocardial delivery catheter in US.

## SEC filing metadata
- accession: 0001437749-26-003582
- form_type: 8-K
- ticker: BCDA
- cik: 0000925741
- company_name: BioCardia, Inc.
- filed_at: 2026-02-10T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- 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/925741/000143774926003582/0001437749-26-003582-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/925741/000143774926003582/bcda20260210c_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001437749-26-003582
- JSON: https://secwatch.observer/filing/0001437749-26-003582.json
- Plain text: https://secwatch.observer/filing/0001437749-26-003582.txt

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