8-K
filed May 28, 2026, 8:00 AM ET
ticker BCDA
CIK 0000925741
regulatory
confidence high
sentiment positive
materiality 0.70
BioCardia Japan PMDA supports CardiAMP cell therapy submission for HFrEF; submission planned Q4 2026
BioCardia, Inc.
- PMDA Consultation Record confirms alignment on remaining questions; positive outcomes credible.
- Estimated 20,000 of 300,000 Japanese HFrEF patients initially eligible for CardiAMP therapy.
- BioCardia plans PMDA submission in Q4 2026 with a Designated Marketing Authorization Holder.
- Clinical data showed 179 sec average exercise tolerance improvement and 82% angina reduction.
- PMDA requested additional details on GDMT compliance, revascularization ineligibility, and adverse events.
Machine-readable event card
- schema_version
- secwatch.filing_event.v1
- accession
- 0001437749-26-018670
- form_type
- 8-K
- ticker
- BCDA
- cik
- 0000925741
- company_name
- BioCardia, Inc.
- filed_at
- 2026-05-28T12:00:11+00:00
- discovered_at
- 2026-05-28T12:05:00.407978+00:00
- generated_at
- 2026-05-28T12:06:59.983266+00:00
- sec_items
- ["7.01", "9.01"]
- event_type
- regulatory
- sentiment
- positive
- materiality_score
- 0.7
- calibrated_materiality_score
- 0.7
- confidence
- high
- secwatch_canonical_url
- https://secwatch.observer/filing/0001437749-26-018670
- json_url
- https://secwatch.observer/filing/0001437749-26-018670.json
- markdown_url
- https://secwatch.observer/filing/0001437749-26-018670.md
- text_url
- https://secwatch.observer/filing/0001437749-26-018670.txt
- edgar_index_url
- https://www.sec.gov/Archives/edgar/data/925741/000143774926018670/0001437749-26-018670-index.htm
- edgar_primary_document_url
- https://www.sec.gov/Archives/edgar/data/925741/000143774926018670/bcda20260528_8k.htm
- generated_by_model
- deepseek-v4-flash:cloud@v2
- review_status
- machine_generated
- human_reviewed
- false
- corrected
- false
- correction_note
- null
- correction_timestamp
- null
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