BioCardia Seeks Approval in Japan for Cell Therapy for Ischemic Heart Failure

BioCardia has had a positive preliminary clinical consultation with Japan's Pharmaceutical and Medical Device Agency (PMDA) on the CardiAMP Heart Failure Trial results. The agency requested additional details, including clarification on positioning of prespecified composite endpoints and clinical development status in the US. BioCardia is completing responses to their questions and anticipates formal clinical consultation near the end of the year. The company aims to enable access for patients with few therapeutic options who showed significant benefits in the CardiAMP HF study.