BioCardia targets Q4 2026 Japan PMDA submission for CardiAMP cell therapy; updates on US trial and pipeline

BioCardia, Inc.

Japan PMDA supports potential approval of CardiAMP for ischemic HFrEF; submission planned for Q4 2026.
Initial Japan target: 20,000 patients; prior cardiac cell therapy reimbursement at $124,000 per procedure.
CardiAMP HF II trial enrolling in US with 4 active centers; FDA may support Premarket Approval.
Helix delivery catheter in discussions with 8 gene/cell therapy programs; allogeneic MSC platform has 2 FDA INDs.
Recent financing closed to fund PMDA submission, US trial enrollment, and partnership discussions.

This headline and bullets were generated automatically by deepseek-v4-flash:cloud@v2 from the public filing. Read the source on SEC.gov before relying on any specific claim. Not investment advice. See methodology for how this pipeline works.