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

DAIC

CMS has reviewed the CardiAMP Heart Failure II Trial and approved the investigational product, related and routine items and services for purposes of Medicare coverage. The CardiAMP clinical development for heart failure is supported by the Maryland Stem Cell Research Fund and is reimbursed by CMS for both treatment and control procedures.

CMS 111
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Biocardia Reports Positive Interim Results from Phase III Cardiamp Cell Therapy Heart Failure Trial, with Compelling Data in Subgroup with Elevated NTproBNP Biomarker for Heart Failure

DAIC

The data was presented today by Amish Raval , MD, Director of Clinical Cardiovascular Research and Professor of Medicine at the University of Wisconsin-Madison at the Technology and Heart Failure Therapeutics (THT) 2024 annual meeting. The CardiAMP HF II trial is expected to similarly secure CMS reimbursement.

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Patient Enrollment Commenced in Pivotal Phase 3 Trial of CardiAMP Cell Therapy for the Treatment of Ischemic Heart Failure

DAIC

The CardiAMP clinical development for heart failure is supported by the Maryland Stem Cell Research Fund and is reimbursed by Center for Medicare and Medicaid Services (CMS) for both treatment and control procedures. CAUTION - Limited by United States law to investigational use.