---
schema_version: "secwatch.filing_event.v1"
accession: "0001437749-26-032887"
form_type: "8-K"
ticker: "BCDA"
cik: "0000925741"
company_name: "BioCardia, Inc."
filed_at: "2026-10-19T13:15:23+00:00"
generated_at: "2026-10-19T13:16:05.902375+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.55
calibrated_materiality_score: 0.55
confidence: "high"
source: SEC EDGAR
---

# BioCardia says FDA accepted Helix catheter De Novo pre-submission; review meeting expected this quarter

## Summary
- FDA accepted BioCardia's revised De Novo pre-submission package for marketing clearance of the Helix transendocardial delivery catheter, per the Oct. 19, 2026 release.
- In May 2026 FDA agreed two pathways exist for Helix clearance and raised no concerns on the product's safety data, performance, or compatibility with general classes of agents.
- FDA confirmed the meeting minutes in August 2026; BioCardia revised and resubmitted the package in September 2026 incorporating CDRH advice.
- Substantive review with written FDA feedback, followed by a meeting to discuss De Novo approval, is expected this quarter.
- Helix data covers 15 clinical trials and nearly 500 patients; clearance could expand partnering with cell, gene and protein therapeutic developers needing heart delivery.

## SEC filing metadata
- accession: 0001437749-26-032887
- form_type: 8-K
- ticker: BCDA
- cik: 0000925741
- company_name: BioCardia, Inc.
- filed_at: 2026-10-19T13:15:23+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.55
- calibrated_materiality_score: 0.55
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/925741/000143774926032887/0001437749-26-032887-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/925741/000143774926032887/bcda20261018_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001437749-26-032887
- JSON: https://secwatch.observer/filing/0001437749-26-032887.json
- Plain text: https://secwatch.observer/filing/0001437749-26-032887.txt

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