16 May 2018 - - The Centers for Medicare and Medicaid Services has approved national reimbursement coverage for San Carlos, California-based cardiovascular regenerative therapies developer BioCardia, Inc.'s (OTC: BCDA) CardiAMP chronic myocardial ischemia (CMI) trial, the company said.
The CardiAMP 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, approved to enroll up to 343 subjects at up to 40 US centers, has the potential to support functional benefit claims sufficient for product registration without a second confirmatory trial.
This second clinical indication of CMI 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 US.
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.
BioCardia is developing regenerative biologic therapies to treat cardiovascular disease. CardiAMP and CardiALLO cell therapies are the company's biotherapeutic product candidates in clinical development.