BioCardia announces completion of consoltation with Japan’s PMDA

BioCardia (BCDA) announces the successful completion of a consultation with Japan’s Pharmaceutical and Medical Device Agency, PMDA, on the next steps for the submission for registration of its lead therapeutic asset, BCDA-01, for the treatment of ischemic heart failure of reduced ejection fraction. “This most recent meeting with PMDA had several important outcomes,” said Peter Altman, Ph.D., BioCardia’s President and Chief Executive Officer.” First, PMDA has invited our next consultation after the submission of our final clinical data with two-year follow-up to review the sufficiency of evidence to support claims of safety and efficacy for the BCDA-01 program. Second, PMDA remains open to the results from the CardiAMP Heart Failure Trial and our previous trials being sufficient evidence for registering CardiAMP Cell Therapy System for patients with heart failure in Japan.”