---
schema_version: "secwatch.filing_event.v1"
accession: "0001437749-26-035408"
form_type: "8-K"
ticker: "BCDA"
cik: "0000925741"
company_name: "BioCardia, Inc."
filed_at: "2026-11-06T13:30:10+00:00"
generated_at: "2026-11-06T13:35:15.327818+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.55
calibrated_materiality_score: 0.55
confidence: "high"
source: SEC EDGAR
---

# BioCardia completes PMDA consultation for CardiAMP, advancing toward Japan marketing approval filing

## Summary
- BioCardia (NASDAQ: BCDA) completed the PMDA consultation on application materials for its CardiAMP Cell Therapy System for ischemic heart failure in Japan.
- CEO Peter Altman said the company is targeting treatment of first patients in Japan and realization of commercial revenues in 2028.
- CardiAMP has been evaluated in three clinical trials involving more than 200 patient procedures, including two randomized, double-blind, placebo-controlled trials.
- BioCardia cautioned that completion of the consultation does not constitute approval; CardiAMP remains subject to PMDA review and Japanese regulatory requirements.
- The announcement came via press release dated November 6, 2026, furnished under Item 8.01 with Exhibit 99.1.

## SEC filing metadata
- accession: 0001437749-26-035408
- form_type: 8-K
- ticker: BCDA
- cik: 0000925741
- company_name: BioCardia, Inc.
- filed_at: 2026-11-06T13:30:10+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.55
- calibrated_materiality_score: 0.55
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/925741/000143774926035408/0001437749-26-035408-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/925741/000143774926035408/bcda20261104_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001437749-26-035408
- JSON: https://secwatch.observer/filing/0001437749-26-035408.json
- Plain text: https://secwatch.observer/filing/0001437749-26-035408.txt

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