BioCardia submits CardiAMP for consultation with Japan’s PMDA

BioCardia (BCDA) announced that it submitted its CardiAMP autologous cell therapy investigational heart failure treatment for clinical consultation with Japan’s Pharmaceuticals and Medical Devices Agency, PMDA. This milestone marks a significant step toward potential regulatory approval in Japan, a key market for advanced heart failure therapies. “Consulting with the PMDA on the totality of clinical evidence from our three trials supporting CardiAMP cell therapy for heart failure is a pivotal step in our ongoing discussions with PMDA to bring this heart failure therapy to patients in Japan,” said Peter Altman, PhD, CEO of BioCardia. “We look forward to incorporating the agency’s insights into our development plans and working towards a successful regulatory submission and review. Success in these efforts could result in our being engaged in a meaningful post marketing study in Japan next year.”