secwatch.observer — SEC 8-K summary
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Issuer:     BioCardia, Inc. (BCDA)
CIK:        0000925741
Form:       8-K
Filed at:   2025-08-04T23:59:59+00:00
Accession:  0001437749-25-024472
Event type: regulatory
Sentiment:  neutral
Materiality: 0.65
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

BioCardia provides Q3/Q4 2025 timelines for FDA and PMDA submissions for CardiAMP and Helix
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- Helix DeNovo 510(k) submission to FDA planned for Q3 2025; based on >4,000 intramyocardial deliveries.
- CardiAMP Cell Therapy FDA meeting request in Q4 2025 to discuss approval pathway using clinical data from three trials.
- Japan PMDA clinical consultation for CardiAMP Cell Therapy expected mid Q4 2025; point-of-care platform already approved in Japan.
- CardiAMP HF II trial actively enrolling at five US centers including Cleveland Clinic and Emory University.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/925741/000143774925024472/0001437749-25-024472-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/925741/000143774925024472/bcda20250803_8k.htm
  HTML page:      https://secwatch.observer/filing/0001437749-25-024472

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