BioCardia announces preliminary consultation with Japan PDMA on CardiAMP results

BioCardia (BCDA) had a preliminary clinical consultation with Japan’s Pharmaceutical and Medical Device Agency on the CardiAMP Heart Failure Trial results previously provided to the agency. The meeting was held in preparation for the formal clinical consultation on acceptability of the clinical data for submission of an application for approval. PMDA requested additional details including clarification on positioning of the prespecified composite endpoints, background on statistical power, clinical rationale for the NTproBNP subgroup and their risk-benefit profile, anticipated target number of patients in Japan, and clinical development status in the United States. BioCardia is completing responses to their questions and anticipates formal clinical consultation near the end of the year. “We look forward to working with the PMDA supporting their reviews of the three completed clinical trials with 178 ischemic heart failure patients,” said Peter Altman, CEO. “Our focus is to enable access for patients with the greatest needs who have few if any therapeutic options. These are the patients who showed the most significant benefits in the recently completed CardiAMP HF study of our autologous minimally invasive cell therapy.”