secwatch.observer — SEC 8-K summary
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Issuer:     BioCardia, Inc. (BCDA)
CIK:        0000925741
Form:       8-K
Filed at:   2025-02-27T23:59:59+00:00
Accession:  0001437749-25-005355
Event type: other_material
Sentiment:  neutral
Materiality: 0.60
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

BioCardia freezes primary outcomes data in Phase 3 CardiAMP HF trial; results at ACC 2025
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- Source data verified and data frozen for 115 patients in double-blind, placebo-controlled Phase 3 trial for ischemic HFrEF.
- Data transferred to Statistical Data Analysis Center core laboratory for analysis.
- Results scheduled for Late-Breaking Clinical Trials symposium at ACC 2025 on March 30, 2025 in Chicago.
- CEO states the study is intended to support safety and effectiveness for US and Japan approvals and Helix delivery system approval.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/925741/000143774925005355/0001437749-25-005355-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/925741/000143774925005355/bcda20250227_8k.htm
  HTML page:      https://secwatch.observer/filing/0001437749-25-005355

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