BioCardia Initiates Patient Enrollment at Emory University School of Medicine for Ongoing CardiAMP HF II Pivotal Study

Core Insights - BioCardia, Inc. is conducting a pivotal Phase III trial, CardiAMP HF II, to evaluate the CardiAMP™ Cell Therapy for patients with ischemic heart failure of reduced ejection fraction [1][2] - Emory University School of Medicine has joined the trial, which aims to enhance microvascular density and reduce fibrosis through autologous mononuclear cell delivery [2][3] - The CardiAMP cell therapy has shown promising results in previous trials, indicating potential benefits for patients with heart failure [3][7] Company Overview - BioCardia is a leader in cellular and cell-derived therapeutics for cardiovascular and pulmonary diseases, with its CardiAMP and CardiALLO cell therapies in clinical development [9] - The company utilizes proprietary delivery systems and pre-procedural cell analysis to enhance the efficacy and safety of its therapies [5][9] Clinical Development - The CardiAMP HF II trial is expected to accelerate patient enrollment, with a target completion date set for 2027 [3][8] - Previous studies have shown statistically significant improvements in survival and quality of life for patients treated with CardiAMP therapy [7] Market Context - Heart failure of reduced ejection fraction (HFrEF) affects approximately 3 million American adults, with projections indicating an increase to over 4 million by 2030 [4] - Existing therapies often fail to manage advanced heart failure symptoms effectively, highlighting the need for innovative treatments like CardiAMP [4][5]