secwatch.observer — SEC 8-K summary
======================================

Issuer:     BioCardia, Inc. (BCDA)
CIK:        0000925741
Form:       8-K
Filed at:   2023-05-10T23:59:59+00:00
Accession:  0001437749-23-013592
Event type: earnings
Sentiment:  neutral
Materiality: 0.60
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

BioCardia Q1 2023 net loss $3.5M; adaptive FDA plan for heart failure trial submitted
--------------------------------------------------------------------------------

- Revenue $64K (flat YoY); net loss $3.5M vs $3.3M; cash used in ops $2.6M.
- Phase III CardiAMP HF trial: adaptive statistical analysis plan submitted to FDA Apr 26; DSMB meeting late June.
- Japan PMDA submission expected Q2 2023 for CardiAMP; roll-in cohort 2-yr survival 100%.
- BCDA-03 allogeneic HFrEF trial first patient expected Q2 2023; BCDA-04 ARDS trial start Q4 2023.
- FDA audit of quality system resulted in zero written observations.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/925741/000143774923013592/0001437749-23-013592-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/925741/000143774923013592/bcda20230510_8k.htm
  HTML page:      https://secwatch.observer/filing/0001437749-23-013592

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