Pivotal Trial Approved for BioCardia's CardiAMP Cell Therapy in Chronic Myocardial Ischemia
January 29, 2018—BioCardia, Inc. announced that the US Food and Drug Administration has approved an investigational device exemption for the company's CardiAMP chronic myocardial ischemia (CMI) trial to treat patients with refractory angina.
According to the company, the CardiAMP investigational cell therapy takes a personalized and minimally invasive approach to the use of a patient's autologous cells in the treatment of cardiovascular disease. The investigational therapy is designed to stimulate the body's natural healing response. In January 2017, the company announced the initiation of the pivotal CardiAMP Heart Failure trial.
BioCardia advised that the CardiAMP CMI pivotal trial will be prospective, multicenter, randomized, sham-controlled, patient- and evaluator-blinded trial. It will validate the safety and efficacy of the company's CardiAMP investigational cell therapy in the treatment of patients with CMI and refractory angina. The trial has been approved to enroll up to 343 patients at up to 40 centers in the United States. The trial has the potential to support functional benefit claims sufficient for product registration without a second confirmatory trial, stated the company.