secwatch.observer — SEC 8-K summary
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Issuer:     BioCardia, Inc. (BCDA)
CIK:        0000925741
Form:       8-K
Filed at:   2026-03-24T23:59:59+00:00
Accession:  0001437749-26-009609
Event type: earnings
Sentiment:  neutral
Materiality: 0.65
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

BioCardia reports 2025 net loss $8.2M; cash $2.5M; regulatory milestones for CardiAMP anticipated
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- Net loss $8.2M (2025) vs $7.9M (2024); revenue $0; cash $2.5M at year-end.
- R&D expenses $5.0M (+$0.6M YoY) due to CardiAMP HF trial closeout and Japan regulatory work.
- CardiAMP HF II trial enrolling at 4 sites; Yale echo data showed reduced LV remodeling in treated patients.
- FDA Q-Sub on CardiAMP approval pathway expected Q1 2026; Japan PMDA formal consultation Q2 2026.
- Helix delivery system Pre-Submission accepted by FDA; meeting with CDRH/CBER scheduled Q2 2026.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/925741/000143774926009609/0001437749-26-009609-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/925741/000143774926009609/bcda20260324_8k.htm
  HTML page:      https://secwatch.observer/filing/0001437749-26-009609

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