secwatch.observer — SEC 8-K summary
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Issuer:     BioCardia, Inc. (BCDA)
CIK:        0000925741
Form:       8-K
Filed at:   2024-12-04T23:59:59+00:00
Accession:  0001437749-24-036648
Event type: regulatory
Sentiment:  positive
Materiality: 0.75
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

BioCardia gets positive PMDA consultation; next step after final CardiAMP HF data in Q1 2025
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- Completed consultation with Japan PMDA; PMDA invited next consultation after submission of final 2-year follow-up data.
- PMDA remains open to using CardiAMP Heart Failure Trial and prior trials for registration in Japan.
- Company anticipates final data from 125-patient CardiAMP HF trial in Q1 2025.
- BCDA-01 holds FDA Breakthrough Designation; U.S. trials supported by CMS reimbursement.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/925741/000143774924036648/0001437749-24-036648-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/925741/000143774924036648/bcda20241204_8k.htm
  HTML page:      https://secwatch.observer/filing/0001437749-24-036648

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