---
schema_version: "secwatch.filing_event.v1"
accession: "0001437749-26-032270"
form_type: "8-K"
ticker: "BCDA"
cik: "0000925741"
company_name: "BioCardia, Inc."
filed_at: "2026-10-07T13:00:12+00:00"
generated_at: "2026-10-12T15:58:38.190021+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# BioCardia to present CardiAMP HF II trial design at HFSA; FDA says trial may support approval

## Summary
- Poster titled "Cardiac Delivery of Autologous Minimally Processed Cell Therapy in HFrEF: Multicenter, Double Blind RCT (CardiAMP HF II)" to be presented at HFSA 2026 in Phoenix, Oct 9-12, 2026.
- Study objective: determine efficacy of high-dose autologous cell treatment for ischemic HFrEF patients on guideline-directed medical therapy but with elevated biomarkers of heart stress.
- FDA approved Category B designation for CardiAMP cell therapy system in three trials; FDA recently agreed ongoing CardiAMP HF II may support approval.
- CEO Peter Altman said the company is advancing the confirmatory CardiAMP HF II trial with world-class centers and has parallel regulatory submissions with FDA and Japan's PMDA.

## SEC filing metadata
- accession: 0001437749-26-032270
- form_type: 8-K
- ticker: BCDA
- cik: 0000925741
- company_name: BioCardia, Inc.
- filed_at: 2026-10-07T13:00:12+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.6
- calibrated_materiality_score: 0.6
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/925741/000143774926032270/0001437749-26-032270-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/925741/000143774926032270/bcda20261007_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001437749-26-032270
- JSON: https://secwatch.observer/filing/0001437749-26-032270.json
- Plain text: https://secwatch.observer/filing/0001437749-26-032270.txt

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