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FDA confirms CardiAMP HF II trial may support approval for ischemic heart failure therapy

Market News
05 Jun 2026
GlobeNewsWire
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Bullish
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BioCardia announced that the FDA confirmed its ongoing CardiAMP Heart Failure II Trial could support Premarket Approval (PMA) for its CardiAMP Cell Therapy, aimed at treating ischemic heart failure with reduced ejection fraction (HFrEF). This therapy uses a patient’s own bone marrow cells to improve heart tissue and has already been deemed safe by the FDA. The FDA typically requires two well-designed trials for approval, and CardiAMP HF II is considered the first of these. The therapy has also received breakthrough designation and reimbursement support, with further regulatory submissions planned in Japan later in 2026.

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