secwatch.observer — SEC 8-K summary
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Issuer:     BioCardia, Inc. (BCDA)
CIK:        0000925741
Form:       8-K
Filed at:   2023-08-09T23:59:59+00:00
Accession:  0001437749-23-022787
Event type: other_material
Sentiment:  negative
Materiality: 0.85
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

BioCardia pauses BCDA-01 heart failure trial after DSMB says likely to miss primary endpoint
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- DSMB recommended pause in BCDA-01 Phase III trial for ischemic heart failure after review shows unlikely to meet FS composite endpoint; no safety issues.
- Q2 2023 revenue $43K, down from $974K YoY; net loss $3.4M vs $2.5M; net cash used in ops $3.2M vs $2.6M.
- BCDA-02 chronic myocardial ischemia trial expects roll-in cohort completion Q4 2023; BCDA-03 allogeneic trial expects first patient Q3 2023.
- Japan PMDA formal consultation for BCDA-01 accepted; Helix platform patent granted in Japan and European intention to grant.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/925741/000143774923022787/0001437749-23-022787-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/925741/000143774923022787/bcda20230808_8k.htm
  HTML page:      https://secwatch.observer/filing/0001437749-23-022787

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