BioCardia announces activation of CardiAMP heart failure II phase 3 study

BioCardia is targeting heart failure and chronic myocardial ischemia as potential indications for its biotherapeutic candidates: autologous CardiAMP cell therapy and allogeneic CardiALLO cell therapy. The Company announces activation of CardiAMP HF II, a randomized controlled pivotal trial of its CardiAMP autologous cell therapy for patients with ischemic heart failure. The study was approved by FDA in Q4 2023 for the treatment of ischemic etiology heart failure of reduced ejection fraction. The data supporting the design of CardiAMP HF II is from the interim results of the ongoing CardiAMP Heart Failure autologous cell therapy study, a randomized, double blind, controlled study that enrolled 125 patients with New York Heart Association Class II and III ischemic heart failure. The interim results of the study will be shared at the upcoming Technology and Heart Failure Therapeutics meeting on March 4, 2024, with final results expected in Q4 2024. The primary endpoint for CardiAMP HF II is a Finkelstein-Schoenfeld composite difference between groups based on all-cause heart death, major adverse cardiac and cerebrovascular events, and quality of life as measured by Minnesota Living with Heart Failure Questionnaire at a minimum of one year and a maximum of two-year follow-up.