---
schema_version: "secwatch.filing_event.v1"
accession: "0001437749-26-017222"
form_type: "8-K"
ticker: "BCDA"
cik: "0000925741"
company_name: "BioCardia, Inc."
filed_at: "2026-05-15T12:05:59+00:00"
generated_at: "2026-05-15T12:12:15.904965+00:00"
event_type: "earnings"
sentiment: "positive"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# BioCardia Q1 net loss $2.3M; PMDA determines CardiAMP safety/efficacy likely sufficient for Japan approval

## Summary
- Net loss $2.3M in Q1 2026 vs $2.7M in Q1 2025; cash $951k as of March 31, 2026.
- PMDA Formal Clinical Consultation determined clinical safety and efficacy likely sufficient for market clearance; alignment on foreign data.
- FDA expressed no safety concerns, benefits intriguing; confirmed PMA pathway; recommended continuing CardiAMP HF II confirmatory trial.
- FDA agreed on two Helix clearance pathways; milestones: Euro PCR presentation Q2 2026, Japan Shonin submission Q4 2026.

## SEC filing metadata
- accession: 0001437749-26-017222
- form_type: 8-K
- ticker: BCDA
- cik: 0000925741
- company_name: BioCardia, Inc.
- filed_at: 2026-05-15T12:05:59+00:00
- event_type: earnings
- sentiment: positive
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 2.02, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/925741/000143774926017222/0001437749-26-017222-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/925741/000143774926017222/bcda20260515_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001437749-26-017222
- JSON: https://secwatch.observer/filing/0001437749-26-017222.json
- Plain text: https://secwatch.observer/filing/0001437749-26-017222.txt

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