BioCardia Seeks Japan PMDA Approval for CardiAMP Heart Failure Therapy

BioCardia, a clinical-stage company specializing in cellular therapeutics for cardiovascular diseases, recently held a positive preliminary clinical consultation with Japan's Pharmaceutical and Medical Device Agency (PMDA) regarding its CardiAMP Heart Failure Trial data. The meeting served as preparation for a formal consultation on the clinical data's acceptability for regulatory submission, with PMDA requesting further clarification on trial endpoints, statistical power, patient subgroups, risk-benefit profiles, and expected patient numbers in Japan. BioCardia is currently addressing these inquiries and aims to complete the formal consultation by the end of the year. CEO Peter Altman emphasized the company's commitment to providing access to patients with ischemic heart failure who have limited treatment options and showed significant benefits in the trial. Despite positive regulatory developments, BioCardia's stock remains rated as a hold due to weak financial performance and bearish market indicators. The company continues to advance its CardiAMP and CardiALLO cell therapy platforms for ischemic heart failure and other cardiac conditions, supported by proprietary delivery technologies.