BioCardia Plans Japan PMDA Submission by End-2026 for 20,000 Patients at $124K Reimbursement
BCDA•BioCardia will submit its CardiAMP Cell Therapy for ischemic HFrEF to Japan PMDA by end-2026 targeting 20,000 of 300,000 patients with $124,000 reimbursement per procedure. It will enroll four US centers in its HF II trial, leverage Helix delivery for eight programs and seek MSC partnerships.
1. Japan PMDA Submission Plans
BioCardia is targeting a submission of its CardiAMP Cell Therapy for ischemic HFrEF to the PMDA in Q4 2026, focusing on an initial patient cohort of 20,000 out of 300,000 potential patients in Japan. Approval could allow reimbursement at $124,000 per procedure and pave the way for expedited registrations in Southeast Asia, Latin America and the Middle East via Japan’s reference country status.
2. US CardiAMP HF II Trial Enrollment
The company plans to enroll four active US study centers in its CardiAMP HF II trial, with each center currently holding patients in the queue. FDA engagement suggests trial results may support a Premarket Approval submission, while cross-training between US and Japanese clinicians will prepare teams for future procedure rollout.
3. Helix Delivery Platform and Pipeline Expansion
BioCardia’s Helix transendocardial delivery catheter paired with its Heart3D fusion imaging platform addresses localized delivery bottlenecks for cardiac regenerative therapies. The system is engaged in early discussions with eight biotherapeutic programs worldwide and is positioned for clinical licensing partnerships once CardiAMP approval is secured.
4. Allogeneic MSC Platform and Strategic Partnerships
The company holds two FDA-approved INDs for its off-the-shelf MSC therapy targeting cardiac and pulmonary indications, leveraging anti-inflammatory mechanisms for high-value applications. BioCardia aims to secure distribution agreements and licensing deals for its MSC pipeline assets to drive additional value beyond cell therapy.
