---
schema_version: "secwatch.filing_event.v1"
accession: "0001437749-26-008499"
form_type: "8-K"
ticker: "BCDA"
cik: "0000925741"
company_name: "BioCardia, Inc."
filed_at: "2026-03-17T23:59:59+00:00"
generated_at: "2026-05-15T11:17:49.305315+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# BioCardia FDA accepts pre-submission package for Helix catheter; review meeting early Q2

## Summary
- FDA accepted pre-submission package for Helix Transendocardial Delivery Catheter; substantive review and meeting scheduled early Q2 2026.
- CDRH to lead review in consultation with CBER; Helix enables minimally invasive intramyocardial delivery of therapeutics/diagnostics.
- CEO states FDA marketing clearance would be meaningful for business; Helix is platform for cardiac cell, gene, and protein therapeutics.
- CardiAMP Cell Therapy Breakthrough Designation (enabled by Helix) acknowledged by FDA in this submission.

## SEC filing metadata
- accession: 0001437749-26-008499
- form_type: 8-K
- ticker: BCDA
- cik: 0000925741
- company_name: BioCardia, Inc.
- filed_at: 2026-03-17T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.6
- calibrated_materiality_score: 0.6
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/925741/000143774926008499/0001437749-26-008499-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/925741/000143774926008499/bcda20260317_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001437749-26-008499
- JSON: https://secwatch.observer/filing/0001437749-26-008499.json
- Plain text: https://secwatch.observer/filing/0001437749-26-008499.txt

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