BioCardia targets Japan PMDA filing for CardiAMP after years of trial delay
The Phase 3 CardiAMP heart failure trial finished in 2025 after five completion-date pushes and a target cut in half; the Japan submission will test whether that record supports a regulatory case.
Executive Summary
- BioCardia plans to take its completed Phase 3 heart failure cell-therapy trial to Japan's drug regulator in the final quarter of 2026, marking the program's first submission outside North America.
- The study that will support the filing spent nearly a decade in enrollment and saw its completion date pushed back five separate times, along with a target cut in half partway through.
- The trial finished enrollment and reached Completed status, but a posted result has not yet reached the public registry, leaving the regulatory case to rest on data not yet visible to outside observers.
- No other cell therapy in heart failure shares BioCardia's target or mechanism class, leaving CardiAMP without a direct precedent to benchmark against inside its own modality.
The submission
BioCardia disclosed the planned Japan filing in a June 8, 2026 press release announcing a stock financing, listing the PMDA submission as one of two named catalysts for 2026 alongside a planned manuscript publication. The filing would cover CardiAMP, an autologous cell therapy delivered to patients with chronic ischemic left ventricular dysfunction following myocardial infarction, and would be the program's first regulatory submission outside the United States and Canada, where the pivotal trial enrolled. BioCardia+1BioCardia Announces $4.4 Million FinancingJun 8, 2026CardiAMP™ Cell Therapy for Heart Failure TrialNCT02438306
The trial behind the filing
The trial the filing will lean on, registered as NCT02438306 and titled the CardiAMP Cell Therapy for Heart Failure Trial, started enrolling in December 2016 and reached Completed status on September 19, 2025. Its primary completion date moved five times over that span: from June 2020 to December 2021, then to December 2022, December 2023, December 2024, and finally February 2025, a cumulative slip of more than four and a half years from the first stated date. The trial's primary endpoint is a composite outcome analyzed with a three-tiered Finkelstein-Schoenfeld hierarchical method in patients with NYHA Class II or III heart failure and a left ventricular ejection fraction between 20% and 40%. NCT02438306CardiAMP™ Cell Therapy for Heart Failure TrialNCT02438306
The enrollment cut
Alongside the October 2023 status change to Active, not recruiting, the trial's enrollment target was cut from 250 to 125 patients, a 50% reduction, and the final actual enrollment matched the reduced figure. That amendment landed at the same point the trial moved out of active recruitment, and the trial went on to complete on the revised target rather than the original one. No result has posted on ClinicalTrials.gov for the trial to date. NCT02438306CardiAMP™ Cell Therapy for Heart Failure TrialNCT02438306
The competitive field
Heart failure carries an established standard of care built on small-molecule agents including SGLT2 inhibitors, mineralocorticoid receptor antagonists, and soluble guanylate cyclase stimulators, none of which share CardiAMP's cell-therapy modality or an identified target. Within cell therapy specifically, three heart failure programs are in clinical testing from other sponsors, including a Phase 3 cardiomyocyte injection program and a Phase 2 program, but both work through different targets than CardiAMP and neither is eligible as a direct comparator on the registry attributes available. CardiAMP's own target and mechanism of action are not classified in available records, which limits how far any target-level comparison can extend beyond modality and indication.
Prior regulatory signals
The trial's history includes FDA Breakthrough Therapy and Breakthrough Device designations reported by the company in 2022, along with a Health Canada No Objection Letter that year enabling the trial to expand into Canada. Those designations reflect the FDA's assessment of unmet need in this population; they do not themselves establish what the trial's primary composite endpoint showed. NCT02438306CardiAMP™ Cell Therapy for Heart Failure TrialNCT02438306
This analysis was produced using AI-assisted reporting systems, AppliedXL data, and official public records. These systems undergo editorial review, quality checks, and regular audits by human experts. Errors may still occur, as with any automated system. Always consult the linked primary sources. Read our AI Editorial Policy.