Flash FinanceUS
Market open S&P 5007,376.86+0.31% Nasdaq24,579.42+1.09% Dow 3051,285.73-0.46% Russell 20002,754.11+0.89% Nasdaq-10026,989.99+1.35% MidCap 4003,602.50+0.56% SmallCap 6001,673.98+0.05% VIX25.64-9.01% 10Y Yield4.86+0.45% Close of Nov 06, 2026
AI brief of an SEC Form 8-K · BioCardia, Inc. (BCDA)

BioCardia completes Japan PMDA consultation for CardiAMP, moving toward approval filing

Positive Impact 3 of 5 legal/regulatory

BioCardia said it finished its clinical consultation with Japan's PMDA on application materials for the CardiAMP Cell Therapy System for ischemic heart failure, a step toward submitting a marketing approval application. The company states that completing consultations does not constitute regulatory approval, and the product remains subject to PMDA review.

Key points

  • Consultation with Japan's PMDA on application materials completed, announced November 6, 2026
  • CardiAMP is intended for ischemic heart failure; CEO Peter Altman targets first patient treatments in Japan and commercial revenues in 2028
  • Completion does not equal regulatory approval; product remains subject to PMDA review

The filing

CompanyBioCardia, Inc. (BCDA)
Form8-K, current report
Filed with the SECNov 6, 2026, 8:30 AM ET
Accession number0001437749-26-035408

Items reported: 8.01 Other Events

Read the filing on SEC.gov ↗

Written by AI on Nov 9, 2026, 7:05 AM ET, from this filing only.

Briefs are written by AI from the filing text and can contain mistakes — open the filing before acting on anything. Impact (1-5) and tone are the AI's reading of the filing for shareholders, not a price forecast. Not investment advice.