NEWS
BioCardia Completes Phase III Randomized Double-Blind Controlled Trial of Autologous Cell Therapy for Ischemic Heart Failure
BioCardia has completed its Phase III CardiAMP HF trial, a randomized, double-blind, placebo-controlled study evaluating the CardiAMP Cell Therapy System for heart failure treatment. The trial enrolled 125 patients across 18 US hospitals, with 115 patients randomized 3:2 between treatment and control groups. The therapy, which received FDA Breakthrough Device Designation, aims to reduce deaths, hospitalizations, and improve quality of life for patients with heart failure of reduced ejection fraction (HFrEF). Top-line results are expected in Q1 2025. The company has submitted plans to the FDA and is pursuing approval discussions with both FDA and Japan's PMDA.
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