---
schema_version: "secwatch.filing_event.v1"
accession: "0001437749-23-022787"
form_type: "8-K"
ticker: "BCDA"
cik: "0000925741"
company_name: "BioCardia, Inc."
filed_at: "2023-08-09T23:59:59+00:00"
generated_at: "2026-06-12T00:05:13.546243+00:00"
event_type: "other_material"
sentiment: "negative"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# BioCardia pauses BCDA-01 heart failure trial after DSMB says likely to miss primary endpoint

## Summary
- DSMB recommended pause in BCDA-01 Phase III trial for ischemic heart failure after review shows unlikely to meet FS composite endpoint; no safety issues.
- Q2 2023 revenue $43K, down from $974K YoY; net loss $3.4M vs $2.5M; net cash used in ops $3.2M vs $2.6M.
- BCDA-02 chronic myocardial ischemia trial expects roll-in cohort completion Q4 2023; BCDA-03 allogeneic trial expects first patient Q3 2023.
- Japan PMDA formal consultation for BCDA-01 accepted; Helix platform patent granted in Japan and European intention to grant.

## SEC filing metadata
- accession: 0001437749-23-022787
- form_type: 8-K
- ticker: BCDA
- cik: 0000925741
- company_name: BioCardia, Inc.
- filed_at: 2023-08-09T23:59:59+00:00
- event_type: other_material
- sentiment: negative
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 2.02, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/925741/000143774923022787/0001437749-23-022787-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/925741/000143774923022787/bcda20230808_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001437749-23-022787
- JSON: https://secwatch.observer/filing/0001437749-23-022787.json
- Plain text: https://secwatch.observer/filing/0001437749-23-022787.txt

## Key facts
- Earnings Releases
  BioCardia, Inc. reported financial results for second quarter of 2023.
  - Period: second quarter of 2023
  - Result: reported results
  source text: today reports financial results for the second quarter of 2023
  evidence_url: https://www.sec.gov/Archives/edgar/data/925741/000143774923022787/0001437749-23-022787-index.htm

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