BioCardia Announces Two Scientific Abstracts Have Been Accepted at the 2024 Technology and Heart Failure Therapeutics Conference

SUNNYVALE, Calif., Jan. 31, 2024 (GLOBE NEWSWIRE) -- BioCardia, Inc. (“BioCardia” or the “Company”) (Nasdaq: BCDA), a biotechnology company focused on advancing late-stage cell therapy interventions for cardiovascular disorders, is targeting heart failure and chronic myocardial ischemia as potential indications for its biotherapeutic candidates: autologous CardiAMP cell therapy and allogeneic CardiALLO cell therapy.

The Company announces that two scientific abstracts on its CardiAMP and its CardiALLO clinical stage therapeutic programs have been accepted for presentation at the Technology and Heart Failure Therapeutics Conference (THT) being held on March 4-6, 2024, in Boston, MA. Both abstracts will be presented in the Late-Breaking Clinical Science/First-In-Human & Early Feasibility Studies session on Monday March 4, 2024.

The first scientific abstract is entitled: “Interim Results from Adaptive Randomized Controlled Trial of Autologous Bone Marrow Mononuclear Cells Using the CardiAMP Cell Therapy System in Patients with Ischemic Heart Failure due to Reduced Left Ventricular Ejection Fraction (HFrEF).” The data to be presented are from the Company’s CardiAMP Phase 3 autologous cell therapy study, an international, randomized, double blind, controlled study that enrolled 125 patients with New York Heart Association Class II and III ischemic heart failure. The primary endpoint is the Finkelstein-Schoenfeld composite difference between groups based on all-cause heart death, major adverse cardiac and cerebrovascular events, and functional capacity as measured by six-minute walk distance. Dr. Amish Raval, Professor of Medicine at the University of Wisconsin at Madison is the lead author on the abstract.

As previously reported, the study showed benefits of reduced all-cause heart death equivalents and reduced major adverse cardiac events without safety concerns, but study was halted as it was not likely to meet its primary endpoint. This scientific presentation will provide detailed trial data including results supporting the design of the CardiAMP Heart Failure II Phase III Trial, recently approved by the FDA and soon to begin enrolling.

The second scientific abstract is entitled: “First in Man CardiALLO NK1R+ MSC Phase I/II Trial in Ischemic NYHA II and III HFrEF”. The data to be presented are from the Company’s CardiALLO Phase I/II allogeneic mesenchymal stem cell therapy study, which began enrollment in a 3+3 dose escalation design in December. The study is enrolling patients with New York Heart Association Class II and III ischemic heart failure, including those who were not eligible for the CardiAMP autologous cell therapy trial. Dr. Carl Pepine, Professor of Medicine at the University of Florida at Gainesville is the lead author on the abstract.