secwatch.observer — SEC 8-K summary
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Issuer:     BioCardia, Inc. (BCDA)
CIK:        0000925741
Form:       8-K
Filed at:   2025-05-06T23:59:59+00:00
Accession:  0001437749-25-014620
Event type: other_material
Sentiment:  neutral
Materiality: 0.35
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

BioCardia initiates patient enrollment at University of Wisconsin for CardiAMP HF II Phase 3 trial
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- University of Wisconsin now enrolling ischemic HFrEF patients in BioCardia's pivotal Phase 3 CardiAMP HF II trial.
- Dr. Amish Raval named site PI and co-national PI for the study.
- Trial uses autologous cell therapy with a three-tier composite outcome: death, nonfatal MACE, and quality-of-life.
- Prior CardiAMP HF study met composite endpoint in elevated NTproBNP patients (p=0.02).
- Advances include cell population analysis for dosing and FDA-approved Morph DNA steerable platform.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/925741/000143774925014620/0001437749-25-014620-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/925741/000143774925014620/bcda20250505_8k.htm
  HTML page:      https://secwatch.observer/filing/0001437749-25-014620

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