BioCardia Announces CMS Approval of Confirmatory Phase III Heart Failure Study Coverage for CardiAMP Cell Therapy

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March 13, 2024—BioCardia, Inc., a developer of cell and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced that it has been approved by the Centers for Medicare and Medicaid Services (CMS) for a Confirmatory Phase III. Announced approval of reimbursement for phase-in clinical trials. Study of CardiAMP autologous cell therapy for the treatment of patients with ischemic heart failure.

CMS reviewed the CardiAMP Heart Failure II study and approved the investigational product, related items, and routine items and services for Medicare coverage. CMS previously issued new technology APC (Ambulatory Payment Classification) codes covering investigational procedures for CardiAMP cell therapy. This includes BioCardia investigational products utilized in the conduct of clinical trial procedures and allows clinical trial centers to receive reimbursement for clinical trial procedures and products.

The CardiAMP Heart Failure II trial has been approved by the FDA to enroll up to 250 patients at up to 40 clinical centers. This study includes an eligibility requirement that patients exhibit a prespecified NT-proBNP level at baseline. The primary endpoint was a hierarchical composite consisting of all-cause mortality, equivalent cardiac deaths from heart transplantation and left ventricular assist device (LVAD) implantation, heart failure hospitalization, worsening of outpatient-treated heart failure events, and quality change. It’s an evaluation. Follow-up period ranges from a minimum of 12 months to a maximum of 24 months.

CMS coverage approval is supported by the scientific rigor of the protocol design and interim data results from the CardiAMP Heart Failure Trial, which were recently presented at the Technology and Heart Failure Treatments 2024 Annual Meeting. Cardiac death equivalents and major cardiac and cerebrovascular events were reduced in all patients. In the subgroup of patients included in the CardiAMP Heart Failure II trial, results showed a significant reduction in the absolute and relative risk of equivalent cardiac death for patients in the treatment arm. Treated patients also had fewer major adverse cardiac events and significantly improved quality of life.

“We are pleased that CMS has provided coverage support for the confirmatory CardiAMP Heart Failure II study,” said Peter Altman, Ph.D., President and CEO of BioCardia. “To my knowledge, there is no proven treatment that reduces mortality in these patients. CardiAMP Heart Failure II has great potential to achieve this outcome by confirming the results of the CardiAMP Heart Failure trial. I am.”

About the CardiAMP Cell Therapy Program

Designated as a breakthrough therapy by the FDA, CardiAMP cell therapy uses a patient’s own bone marrow cells delivered to the heart through a minimally invasive catheter-based procedure and has the potential to stimulate the body’s natural healing response. there is. CardiAMP cell therapy incorporates three unique elements not previously utilized in investigational cardiac cell therapies. Preoperative cell analysis for patient selection, high targeted doses of cells, and a unique delivery system proven to be safer than other intramyocardial delivery systems. And it achieves dramatic success in cell retention. Her clinical development of CardiAMP for heart failure was supported by the Maryland Stem Cell Research Foundation and is reimbursed by his CMS for both treatment and management procedures.

Caution – Per US law, for research use only.

For more information, please visit www.biocardia.com.