secwatch.observer — SEC 8-K summary
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Issuer:     BioCardia, Inc. (BCDA)
CIK:        0000925741
Form:       8-K
Filed at:   2026-09-10T12:30:13+00:00
Accession:  0001437749-26-030023
Event type: regulatory
Sentiment:  positive
Materiality: 0.60
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

BioCardia targets Q4 2026 Shonin submission for CardiAMP; FDA supports PMA path
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- Targets Q4 2026 Shonin pre-market submission to Japan's PMDA for CardiAMP cell therapy for ischemic heart failure.
- FDA meeting minutes confirm ongoing CardiAMP HF II pivotal trial may support Premarket Approval (PMA) in the U.S.
- Plans to submit follow-on De Novo pre-submission for Helix transendocardial delivery catheter in Q3 2026.
- Advancing Heart3D Fusion Imaging with partner CART-Tech toward potential FDA 510(k) submission.
- CEO Peter Altman to present at H.C. Wainwright 28th Annual Global Investment Conference, Sept 14-16, 2026.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/925741/000143774926030023/0001437749-26-030023-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/925741/000143774926030023/bcda20260908_8k.htm
  HTML page:      https://secwatch.observer/filing/0001437749-26-030023

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