secwatch.observer — SEC 8-K summary
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Issuer:     BioCardia, Inc. (BCDA)
CIK:        0000925741
Form:       8-K
Filed at:   2025-07-16T23:59:59+00:00
Accession:  0001437749-25-022772
Event type: other_material
Sentiment:  neutral
Materiality: 0.50
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Henry Ford Health enrolls first patients in BioCardia's Phase 3 CardiAMP HF II trial
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- Henry Ford Health (Detroit) is now enrolling ischemic HFrEF patients in BioCardia's pivotal CardiAMP HF II trial.
- CardiAMP HF II is a 250-patient randomized, placebo-controlled confirmatory study of autologous bone marrow cell therapy.
- Primary composite endpoint includes all-cause death, nonfatal MACE, and quality of life; prior CardiAMP HF trial met significance for elevated NTproBNP patients.
- Therapy involves same-day cell harvest, bedside processing, and minimally invasive catheter delivery.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/925741/000143774925022772/0001437749-25-022772-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/925741/000143774925022772/bcda20250716_8k.htm
  HTML page:      https://secwatch.observer/filing/0001437749-25-022772

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer