CMS Approves CardiAMP Phase III Heart Failure Trial Coverage

BioCardia, a California-based company specializing in cellular therapies for heart and lung diseases, has received a significant boost with the Centers for Medicare & Medicaid Services (CMS) granting reimbursement coverage for its CardiAMP autologous cell therapy clinical trial. This therapy is aimed at treating patients suffering from ischemic heart failure and is currently in its confirmatory Phase III stage.
The CardiAMP Heart Failure II Trial has been given the green light to enroll a maximum of 250 patients across 40 clinical centers. The study is designed with a specific criterion that requires patients to have a certain NT-proBNP level at the outset. Its primary goal is to assess a composite of outcomes, including all-cause mortality, heart transplant or left ventricular assist device implantation, hospitalizations due to heart failure, outpatient treatments for worsening heart failure, and changes in the quality of life over a period ranging from 12 to 24 months.
The CMS's decision to cover the trial is underpinned by the robustness of the trial's protocol and the interim data presented at the Technology and Heart Failure Therapeutics 2024 conference. The data showed a decrease in cardiac death equivalents and major adverse cardiac and cerebrovascular events across all patients. Notably, the subgroup targeted in the CardiAMP Heart Failure II Trial exhibited a significant reduction in heart death equivalents, fewer major adverse cardiac events, and a marked improvement in life quality.
BioCardia's President and CEO, Peter Altman, expressed satisfaction with the CMS's support, highlighting the potential of CardiAMP Heart Failure II to establish a new standard of care by corroborating the results of the previous CardiAMP Heart Failure Trial. The CardiAMP Cell Therapy Program, recognized by the FDA as a Breakthrough Therapy, utilizes a patient's bone marrow cells in a minimally invasive procedure. This therapy is unique due to its three proprietary components: a pre-procedure cell analysis for patient selection, a high dosage of cells, and a proprietary delivery system that has demonstrated higher safety and cell retention rates than other methods.
BioCardia, headquartered in Sunnyvale, California, is advancing cellular and cell-derived therapeutics for cardiovascular and pulmonary diseases. Their platforms, CardiAMP autologous and CardiALLO allogeneic cell therapies, are at the forefront of heart disease treatment. The company also collaborates with partners to provide its biotherapeutic delivery system and related development services for heart-focused treatments.