NEW YORK – The US Centers for Medicare & Medicaid Services has agreed to reimburse BioCardia's investigational, autologous cell therapy and the ancillary costs of studying it in patients with ischemic heart failure in a Phase III trial, the firm said Tuesday.
Sunnyvale, California-based BioCardia is studying the cell therapy, known as CardiAMP, within the confirmatory Phase III CardiAMP Heart Failure II study. The agency's decision will enable Medicare-eligible patients in this trial to receive coverage for BioCardia's treatment as well as for related and routine items and services.
BioCardia in 2016 launched a pivotal Phase III randomized-controlled trial, the CardiAMP Heart Failure study, but last year determined that the cell therapy was unlikely to best the control arm and demonstrate an improvement in the primary composite endpoint comprising all-cause death, major adverse cardiac events, and a six-minute walking test.
The company has since said that it will enroll up to 250 patients at up to 40 clinical sites in a second iteration of the study, homing in on a subset of responders identified in the earlier trial, specifically those with elevated levels of N-terminal pro B-type natriuretic peptide (NT-proBNP), a biomarker associated with cardiac failure and stress. The new trial will also feature a different composite endpoint that tracks all-cause death, hospitalizations due to heart failure, and worsening heart failure in patients treated in the outpatient setting.