BioCardia®, Inc., a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today announced that the Centers for Medicare and Medicaid Services (CMS) has approved national reimbursement coverage for the CardiAMP Chronic Myocardial Ischemia Trial.
"We are thankful for the CMS decision to approve reimbursement for our potentially life-changing, pivotal clinical study in chronic myocardial ischemia," said Eric Duckers, MD, PhD, Chief Medical Officer of BioCardia. "Medicare reimbursement in the pivotal trial for our second indication of the CardiAMP Cell Therapy System significantly enhances the Company's ability to complete this important trial, which if successful, has the potential to provide the first approved cell therapy in the U.S. for patients suffering from chronic refractory angina (RA)."
The CardiAMP Chronic Myocardial Ischemia (CMI) Trial is 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 refractory angina. The trial has been approved to enroll up to 343 subjects at up to 40 U.S. centers. This trial has the potential to support functional benefit claims sufficient for product registration without a second confirmatory trial.
In the U.S., 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 RA not amenable to further revascularization that suffer with severely limiting symptoms. These patients suffer from poor perceived health status and psychological distress, have significant impairment in quality of life, and represent a burden to the healthcare system due to significant use of resources. Current therapies have limitations or are associated with minimal reduction in angina.
This second clinical indication of chronic myocardial ischemia with refractory angina for the CardiAMP investigational cell therapy follows the company's FDA-approved pivotal clinical trial of CardiAMP cell therapy in ischemic heart failure, which is currently enrolling patients at up to 40 centers in the U.S. 1
"CMS approval of reimbursement for the CardiAMP CMI Trial is an important milestone for the company," said BioCardia CEO Peter Altman. "It is a positive step towards developing a new treatment strategy that could have tremendous benefit for patients with refractory angina. This decision by CMS enables BioCardia to offset significant clinical research costs and may enable us to complete pivotal trials for both indications without a strategic partner. The investigational heart failure and chronic myocardial ischemia pivotal trials provide BioCardia with two distinct pivotal clinical programs where clinical data to-date supports that patients will have improved quality of life and reduced mortality, with no treatment-related cardiac complications."
Covered costs in the trial are anticipated to include patient screening, the CardiAMP Cell Therapy System and procedure, and clinical follow-up at one and two years after the procedure. Private insurance plans covering 50 million insured Americans follow this CMS reimbursement policy and are similarly anticipated to cover these costs in the clinical trial.