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BioCardia says Japan PMDA deems CardiAMP data sufficient for market clearance

PUBT·04/20/2026 12:03:34
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BioCardia says Japan PMDA deems CardiAMP data sufficient for market clearance
  • Japan PMDA determined U.S. clinical safety and efficacy data for BioCardia CardiAMP Cell Therapy in ischemic heart failure is likely sufficient to support market clearance.
  • Consultation aligned on acceptability of foreign clinical data, intended patient indications, post-marketing study expectations in Japan.
  • BioCardia expects PMDA minutes to set feedback and timing for a potential regulatory filing.


Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. BioCardia Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 202604200800PRIMZONEFULLFEED9692689) on April 20, 2026, and is solely responsible for the information contained therein.