secwatch.observer — SEC 8-K summary
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Issuer:     BioCardia, Inc. (BCDA)
CIK:        0000925741
Form:       8-K
Filed at:   2026-11-06T13:30:10+00:00
Accession:  0001437749-26-035408
Event type: regulatory
Sentiment:  positive
Materiality: 0.55
Item codes: 8.01, 9.01
LLM model:  deepseek-v4.1-flash:cloud@v2

BioCardia completes PMDA consultation for CardiAMP, advancing toward Japan marketing approval filing
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- BioCardia (NASDAQ: BCDA) completed the PMDA consultation on application materials for its CardiAMP Cell Therapy System for ischemic heart failure in Japan.
- CEO Peter Altman said the company is targeting treatment of first patients in Japan and realization of commercial revenues in 2028.
- CardiAMP has been evaluated in three clinical trials involving more than 200 patient procedures, including two randomized, double-blind, placebo-controlled trials.
- BioCardia cautioned that completion of the consultation does not constitute approval; CardiAMP remains subject to PMDA review and Japanese regulatory requirements.
- The announcement came via press release dated November 6, 2026, furnished under Item 8.01 with Exhibit 99.1.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/925741/000143774926035408/0001437749-26-035408-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/925741/000143774926035408/bcda20261104_8k.htm
  HTML page:      https://secwatch.observer/filing/0001437749-26-035408

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