Japan's Pharmaceutical and Medical Device Agency (PMDA) confirmed alignment on requirements for the regulatory submission of CardiAMP cell therapy for ischemic heart failure (HFrEF). The therapy targets an estimated 20,000 eligible patients in Japan out of a total population of 300,000 HFrEF patients. Clinical data demonstrated a 179-second increase in exercise tolerance and an 82% reduction in angina episodes at six months, with benefits persisting through two years. BioCardia plans to submit its regulatory application within seven months, targeting a Q4 2026 submission date. The company intends to partner with a Designated Marketing Authorization Holder to facilitate regulatory review and commercialization.