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BioCardia presents CardiAMP HF II trial design at HFSA, FDA signals trial may support approval
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BioCardia presented the CardiAMP HF II trial design at HFSA and noted FDA agreement that the trial may be sufficient to support approval. Key Highlights: Presented CardiAMP HF II multicenter, double-blind RCT design at HFSA Annual Scientific Meeting in Phoenix. Study aims to test high-dose autologous cell therapy efficacy in ischemic HFrEF patients on guideline therapy with elevated heart-stress biomarkers. FDA granted category B designation for CardiAMP across three…