---
schema_version: "secwatch.filing_event.v1"
accession: "0001437749-26-010967"
form_type: "8-K"
ticker: "BCDA"
cik: "0000925741"
company_name: "BioCardia, Inc."
filed_at: "2026-04-02T23:59:59+00:00"
generated_at: "2026-05-15T07:55:09.664679+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# BioCardia files FDA meeting request for CardiAMP HF accelerated approval; subgroup shows risk reduction

## Summary
- Submitted CardiAMP HF clinical study data to FDA; meeting expected Q2 2026 under Breakthrough Designation.
- Subgroup with elevated biomarkers showed 47% relative risk reduction in all-cause cardiac death.
- Same subgroup had 37% relative risk reduction in non-fatal major adverse cardiac events (stroke, MI, hospitalization).
- Quality of life improvements were statistically significant (p=0.04) in the elevated-biomarker subgroup.
- Seeking accelerated approval for CardiAMP System in ischemic HFrEF.

## SEC filing metadata
- accession: 0001437749-26-010967
- form_type: 8-K
- ticker: BCDA
- cik: 0000925741
- company_name: BioCardia, Inc.
- filed_at: 2026-04-02T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/925741/000143774926010967/0001437749-26-010967-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/925741/000143774926010967/bcda20260402_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001437749-26-010967
- JSON: https://secwatch.observer/filing/0001437749-26-010967.json
- Plain text: https://secwatch.observer/filing/0001437749-26-010967.txt

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