secwatch.observer — SEC 8-K summary
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Issuer:     BioCardia, Inc. (BCDA)
CIK:        0000925741
Form:       8-K
Filed at:   2025-02-13T23:59:59+00:00
Accession:  0001437749-25-003677
Event type: other_material
Sentiment:  positive
Materiality: 0.60
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

BioCardia completes low-dose enrollment in CardiALLO allogeneic MSC HFrEF trial
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- Enrolled and dosed 3 patients in low-dose cohort (20M cells) of Phase I/II CardiALLO trial.
- Trial is first prospective allogeneic MSC study targeting HFrEF patients with elevated heart stress/inflammation markers.
- DSMB safety review expected March 2025; next dose escalation (100M cells) to follow.
- Used Morph DNA steerable guide for enhancing cell delivery during treatment procedures.
- Program aims to support pivotal US studies and conditional time-limited approval in Japan.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/925741/000143774925003677/0001437749-25-003677-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/925741/000143774925003677/bcda20250213_8k.htm
  HTML page:      https://secwatch.observer/filing/0001437749-25-003677

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