-+ 0.00%
-+ 0.00%
-+ 0.00%

BioCardia targets Q4 2026 Japan PMDA filing for CardiAMP cell therapy approval

PUBT·06/18/2026 12:04:37
Listen to the news
BioCardia targets Q4 2026 Japan PMDA filing for CardiAMP cell therapy approval
  • BioCardia set a Q4 2026 goal for a Shonin submission to Japan’s PMDA for CardiAMP cell therapy in ischemic HFrEF.
  • Planning initial Japan commercialization around a 20,000-patient subgroup of an estimated 300,000 ischemic heart-failure population.
  • Targeting U.S. enrollment acceleration for the CardiAMP HF II confirmatory trial, positioned for potential FDA Premarket Approval support.
  • Seeking partnerships to expand Helix and Heart3D as a delivery platform for cardiac gene and cell therapies, citing eight active discussions.
  • Advancing licensing options for an allogeneic MSC platform with two FDA INDs, positioned for cardiac and pulmonary indications.


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: 202606180800PRIMZONEFULLFEED9748971) on June 18, 2026, and is solely responsible for the information contained therein.