FDA Approves BioCardia's CardiAMP Protocol for Autologous Cell Therapy in Ischemic Heart Failure
BioCardia has received FDA approval for its Phase III clinical trial of CardiAMP autologous cell therapy for the treatment of patients with ischemic heart failure. The ongoing CardiAMP Heart Failure trial has shown promising results, including a reduction in heart death and major adverse cardiovascular events. The approved CardiAMP Heart Failure II study will have modified eligibility requirements and primary efficacy endpoints. The trial aims to provide evidence to support FDA approval and marketing registration for the therapy.