BioCardia announces expected CardiAMP heart failure Japan approval timeline

BioCardia announced that Japan Pharmaceutical and Medical Device Agency minutes support the Company’s understanding that CardiAMP autologous cell therapy may be approved for the treatment of patients with ischemic heart failure with reduced ejection fraction based on follow-up data from the patients currently enrolled in the CardiAMP Heart Failure Trial that will be available in Q4 2024. BioCardia has previously reported that although the primary endpoint of CardiAMP HF would most likely not have been met at one year; there was both reduced mortality and reduced major adverse cardiovascular events in treated patients compared to controls at two years follow-up. PMDA and its medical advisors have seen these and additional results that will be presented and published in the appropriate peer reviewed scientific forums. The FDA reviewed this data and recently approved the CardiAMP Heart Failure II Study protocol. BioCardia will follow PMDA’s process to confirm the regulatory pathway ahead. This is expected to include a clinical consultation with PMDA in the second or third quarter of 2024 on clinical data from its three sponsored trials: TABMMI, TAC-HFT, and CardiAMP HF. These studies include almost two hundred patients followed-up for an average of 1.9 years and each has shown benefit to patients with no treatment emergent safety concerns. With PMDA confirmation, BioCardia expects to submit for approval in Japan based on the data available in late Q4 2024.