FDA Indicates Potential Approval Path for BioCardia's CardiAMP Cell Therapy for Heart Failure
FDA Confirms CardiAMP HF II May Support Premarket Approval of CardiAMP Cell Therapy for Ischemic HFrEF
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BioCardia, Inc. received FDA feedback confirming that its CardiAMP Cell Therapy may support Premarket Approval (PMA) for treating ischemic heart failure with reduced ejection fraction (HFrEF). This therapy uses patients' own bone marrow cells to improve heart function, potentially benefiting over one million patients in the U.S.
- 01The FDA's Q-Sub Meeting minutes indicate that the CardiAMP Heart Failure II Trial may support PMA for market clearance.
- 02Ischemic heart failure affects over one million patients in the U.S., highlighting the urgent need for effective therapies.
- 03CardiAMP Cell Therapy utilizes a patient's own bone marrow cells in a minimally invasive procedure.
- 04The therapy has received FDA Breakthrough designation, indicating its potential significance in treating heart failure.
- 05Clinical development is supported by the Maryland Stem Cell Research Fund and is reimbursed by the Centers for Medicare and Medicaid Services.
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BioCardia, Inc., based in Sunnyvale, California, announced that the FDA has confirmed the potential for its CardiAMP Cell Therapy to receive Premarket Approval (PMA) for treating ischemic heart failure with reduced ejection fraction (HFrEF). This therapy, which uses a patient's own bone marrow cells, aims to enhance capillary density and reduce myocardial tissue fibrosis through a minimally invasive catheter-based procedure. The FDA's feedback came during a Q-Sub Meeting with the Center for Biologics Evaluation and Research, suggesting that the ongoing CardiAMP Heart Failure II Trial may fulfill the requirements for PMA, which is essential for high-risk medical device approval. The FDA has previously recognized the safety of the CardiAMP Cell Therapy, a critical factor for reimbursement by Medicare and Medicaid. BioCardia's CEO, Peter Altman, emphasized the pressing need for therapeutic options for patients suffering from ischemic heart failure. The therapy has also received Breakthrough designation from the FDA and is supported by the Maryland Stem Cell Research Fund.
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The potential approval of CardiAMP Cell Therapy could provide a new treatment option for over one million patients with ischemic heart failure in the U.S.
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