U.S. Food and Drug Administration (FDA) has approved BioCardia‘s Investigational Device Exemption for the CardiAMP Chronic Myocardial Ischemia (CMI) Trial to treat patients with refractory angina (RA). The CardiAMP Chronic Myocardial Ischemia Trial will be a prospective, multi-center, randomized, sham-controlled, patient- and evaluator-blinded pivotal trial to validate the safety and efficacy of CardiAMP investigational cell therapy in the treatment of patients having CMI with RA.
It is estimated that between 600,000 and 1.8 million patients suffer from RA, with approximately 75,000 new cases diagnosed each year. Despite improvements in revascularization techniques, there is a growing population of patients with chronic refractory angina not amenable to further revascularization that suffer with severely limiting symptoms.
BioCardia CEO Peter Altman said “It is a step towards developing a new treatment strategy that could have tremendous benefit for patients with refractory angina. Approval of this second pivotal trial further demonstrates BioCardia’s leadership in the treatment of heart disease.”
The CardiAMP investigational cell therapy takes a personalized and minimally-invasive approach to the use of a patient’s own cells (autologous cells) in the treatment of cardiovascular disease. The investigational therapy is designed to stimulate the body’s natural healing response.