---
schema_version: "secwatch.filing_event.v1"
accession: "0001437749-26-028778"
form_type: "8-K"
ticker: "BCDA"
cik: "0000925741"
company_name: "BioCardia, Inc."
filed_at: "2026-08-24T12:30:08+00:00"
generated_at: "2026-08-24T12:35:33.093306+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# BioCardia gets FDA confirmation of Helix catheter meeting minutes; De Novo submission planned this quarter

## Summary
- FDA confirmed final meeting minutes from May 2026 Pre-Submission Meeting on Helix Transendocardial Delivery Catheter System.
- BioCardia intends to submit follow-on pre-submission for Helix this quarter, incorporating agency advice.
- Successful De Novo clearance could enable independent Helix market clearance and enhance partnering for cell/gene/protein therapeutics.
- CEO Peter Altman stated the submission could enable Helix approval via De Novo pathway.

## SEC filing metadata
- accession: 0001437749-26-028778
- form_type: 8-K
- ticker: BCDA
- cik: 0000925741
- company_name: BioCardia, Inc.
- filed_at: 2026-08-24T12:30:08+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.6
- calibrated_materiality_score: 0.6
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/925741/000143774926028778/0001437749-26-028778-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/925741/000143774926028778/bcda20260821_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001437749-26-028778
- JSON: https://secwatch.observer/filing/0001437749-26-028778.json
- Plain text: https://secwatch.observer/filing/0001437749-26-028778.txt

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