RegulatoryJun 18, 2026, 08:01 AM
BioCardia Targets Japan PMDA Approval for CardiAMP Cell Therapy by Q4 2026
AI Summary
BioCardia, Inc. announced its strategic priorities, focusing on the submission for approval of CardiAMP Cell Therapy for ischemic heart failure of reduced ejection fraction (HFrEF) to Japan's PMDA by the end of 2026. This initiative is considered a transformative business opportunity, with potential reimbursement of $124,000 per procedure for an initial target of 20,000 patients. The company also continues enrollment for the CardiAMP HF II Trial in the US and is pursuing strategic partnerships for its Helix/Heart3D delivery platform and allogeneic MSC therapies, supported by a recent capital raise.
Key Highlights
- BioCardia targets Japan PMDA submission for CardiAMP Cell Therapy for ischemic HFrEF by Q4 2026.
- Initial approval in Japan could address 20,000 patients out of an estimated 300,000 with ischemic heart failure.
- Previous cardiac cell therapies in Japan had reimbursement at $124,000 per procedure.
- Company is driving enrollment for the confirmatory CardiAMP HF II Trial in the United States.
- Helix/Heart3D delivery platform has active early discussions with eight gene and cell therapies for cardiac indications.
- Allogeneic mesenchymal stem cell (MSC) therapy platform has two FDA-approved Investigational New Drug Applications (INDs).
- Recent capital raise is expected to fund the Japan submission and US trial enrollment.
- Japan's status as a Reference Country and MDSAP member enables expedited registration in other regions.
Price Impact
More from BCDA