BioCardia announced that the FDA has approved a protocol amendment for the CardiAMP Heart Failure II Trial, BioCardia’s confirmatory Phase 3 trial of its autologous CardiAMP cell therapy product candidate for patients with ischemic heart failure of reduced ejection fraction, HFrEF. The protocol amendment allows patients who would have previously been excluded from treatment to receive additional cell deliveries to achieve the same target minimum dosage utilizing a treatment plan informed by the preprocedural CardiAMP Cell Population Analysis.
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