RegulatoryMay 28, 2026, 08:02 AM
BioCardia: Japan PMDA Supports CardiAMP Cell Therapy Approval Submission
AI Summary
BioCardia, Inc. announced that Japan's Pharmaceutical and Medical Device Agency (PMDA) supports the submission for regulatory approval of its CardiAMP® cell therapy for ischemic heart failure of reduced ejection fraction (HFrEF). The PMDA confirmed alignment on remaining questions and found the trial's positive outcomes credible, noting an urgent unmet clinical need. The therapy targets an estimated 20,000 of 300,000 eligible patients in Japan, with submission anticipated in Q4 2026. BioCardia plans for post-marketing studies and collaboration with Japanese academic societies.
Key Highlights
- Japan's PMDA supports regulatory submission for BioCardia's CardiAMP cell therapy for ischemic heart failure.
- Submission for regulatory approval is anticipated in Q4 2026.
- An estimated 20,000 of 300,000 patients in Japan are initially eligible for the therapy.
- The CardiAMP procedure was well tolerated with no treatment emergent major adverse cardiac events.
- Patients showed increased exercise tolerance, improving by an average of 179 seconds, persisting for two years.
- Angina episodes were reduced by an average of 82% by six months after treatment.
- PMDA requested BioCardia demonstrate patient eligibility criteria and provide additional details on adverse events.
Price Impact
More from BCDA