BioCardia Presents CardiAMP HF II Trial Design at Heart Failure Society of America Annual Scientific Meeting
BioCardia announced the presentation of its CardiAMP HF II trial design at the HFSA Annual Scientific Meeting. The trial evaluates high-dose autologous cell therapy for patients with ischemic heart failure with reduced ejection fraction. The FDA has granted category B designation for the CardiAMP system and agreed that the ongoing CardiAMP HF II trial may be sufficient to support FDA approval. BioCardia is advancing regulatory submissions with the FDA and Japan's PMDA.