BioCardia, Inc. (BCDA) announced late-breaking echocardiography results from Phase 3 CardiAMP Heart Failure (HF) trial, showing evidence of reduced adverse cardiac remodeling in treated patients.
The results were presented at the Technology and Heart Failure Therapeutics (THT) conference by Dr. Amish Raval, National Co-Principal Investigator of the trial. Patients receiving the investigational CardiAMP autologous cell therapy demonstrated decreased pathological left ventricular remodeling compared to controls, aligning with earlier findings of reduced major adverse cardiovascular events and improved quality of life.
In a prespecified subgroup of patients with elevated NT-proBNP, a biomarker of heart stress, the differences between treated and control groups were both clinically meaningful and statistically significant. Experts noted that reduced ventricular size in ischemic heart failure is strongly prognostic for better long-term outcomes.
CardiAMP Cell Therapy, which has FDA Breakthrough designation, uses a patient's own bone marrow cells delivered via minimally invasive catheter-based procedure. The therapy aims to improve microvascular function by increasing capillary density and reducing tissue fibrosis. Development is supported by the Maryland Stem Cell Research Fund and reimbursed by CMS.
BioCardia stated that these findings add to the growing body of evidence supporting CardiAMP's potential benefit for patients with ischemic heart failure of reduced ejection fraction.
BCDA has traded between $1.00 and $3.20 over the past year. The stock is currently trading at $1.26, down 6.67%.
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