BioCardia Initiates Enrollment at Four Sites, Advances FDA and PMDA CardiAMP Consultations
BioCardia has enrolled patients at four US centers in its confirmatory CardiAMP HF II trial and received preliminary clinical consultation from Japan’s PMDA on existing trial data. Blinded Yale lab echocardiography results showed >20 ml/m2 and 15 ml/m2 LV volume reductions in biomarker-high subgroup (p=0.02, p=0.01).
1. Regulatory Engagements
BioCardia is engaging with the FDA Center for Biologics Evaluation and Research on a Q-Sub request to extend CardiAMP System labeling to ischemic HFrEF, and its Helix catheter Pre-Submission is under review by FDA CDRH. In Japan, BioCardia has received preliminary clinical consultation from PMDA and will hold formal consultations on the acceptability of existing trial data for Shonin approval.
2. Clinical Enrollment Expansion
In October and November 2025, BioCardia began enrollment in the confirmatory CardiAMP HF II trial at University of Wisconsin–Madison and Henry Ford Health System, with Emory University and BayCare Morton Plant Mease Hospital now also active, bringing the total to four US centers enrolling patients.
3. Positive Clinical Data
Blinded core lab echocardiography results measured by Yale University demonstrated left ventricular end diastolic and end systolic volume reductions over time in treated patients versus controls, with clinically meaningful subgroup differences exceeding 20 ml/m2 and 15 ml/m2 in high-biomarker patients (p=0.02, p=0.01) and primary and key secondary endpoints trending positive.
4. Upcoming Milestones
BioCardia has submitted a detailed manuscript of the CardiAMP HF study for peer review and expects to file the FDA Q-Sub request in the first quarter of 2026. The company also anticipates a formal PMDA consultation in Japan to align on data submissions and plans to advance Phase 2 of its CardiALLO program after completing patient safety assessments.