BioCardia reported that Japan’s Pharmaceutical and Medical Device Agency (PMDA) issued a Consultation Record supporting a regulatory submission for CardiAMP cell therapy for ischemic heart failure with reduced ejection fraction, based on the company’s three completed clinical trials.
According to the company, the PMDA confirmed alignment on remaining questions to address before and as part of the submission for patients with elevated NTproBNP on stable guideline-directed medical therapy.
The agency noted the trial outcomes were credible and estimated about 20,000 of 300,000 Japanese patients would be initially eligible. The PMDA requested a demonstration that enrolled patients were on GDMT and not eligible for revascularization and asked for additional details for each incidence of all-cause death, heart transplantation or left ventricular assist device implantation.
As part of approval review, the agency requested post-marketing study plans covering patient selection criteria, clinical decision-making, medical infrastructure and specialist involvement; BioCardia was guided to collaborate with Japanese academic societies on proper-use guidelines, training and post-market surveillance.
BioCardia plans a PMDA submission in seven months with a Designated Marketing Authorization Holder and intends to pursue commercialization while conducting required post-market studies.
