BioCardia's CardiAMP HF II Trial May Support FDA PMA

Key Highlights

• FDA confirmed the ongoing CardiAMP Heart Failure II Trial may support Premarket Approval (PMA).
• PMA is the most rigorous device marketing application for high-risk medical devices.
• The CardiAMP Cell Therapy System treats ischemic heart failure of reduced ejection fraction (HFrEF).
• FDA previously indicated a preference for two well-designed trials for approval in large indications.
• FDA previously determined the CardiAMP Cell Therapy System is safe, enabling Medicare/Medicaid reimbursement.
• BioCardia plans to complete the US trial for PMA and seek regulatory approval in Japan.