BioCardia Announces Activation of CardiAMP Heart Failure II Phase 3 Pivotal Study Recently Approved by FDA

SUNNYVALE, Calif., Feb. 08, 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 activation of CardiAMP HF II, a randomized controlled pivotal trial of its CardiAMP autologous cell therapy for patients with ischemic heart failure. The study was approved by FDA in Q4 2023 for the treatment of ischemic etiology heart failure of reduced ejection fraction (HFrEF). Study activation includes study-wide Institutional Review Board (IRB) approval for proceeding with the study as well as formally addressing the many requirements of performing a double blinded randomized controlled multi center interventional biotherapeutic study.

The data supporting the design of CardiAMP HF II is from the interim results of the ongoing CardiAMP Heart Failure autologous cell therapy study (CardiAMP HF), a randomized, double blind, controlled study that enrolled 125 patients with New York Heart Association Class II and III ischemic heart failure. The interim results of the study will be shared at the upcoming Technology and Heart Failure Therapeutics meeting on March 4, 2024, with final results expected in Q4 2024.

The primary endpoint for CardiAMP HF II is a Finkelstein-Schoenfeld composite difference between groups based on all-cause heart death, major adverse cardiac and cerebrovascular events, and quality of life as measured by Minnesota Living with Heart Failure Questionnaire at a minimum of one year and a maximum of two-year follow-up. The FDA approved trial size is 250 patients which has greater than 90 percent power (statistical probability of success).

“Now that the study is activated, we are working with our interventional heart failure network and individual clinical sites to complete the final steps to begin patient enrollment,” said Dr. Peter Altman, BioCardia Chief Executive Officer, and President. “The potential for rapid enrollment in this trial is significant. There are enormous operational benefits from experience with our interventional heart failure network, efficiencies in the CardiAMP II protocol design, and both physician and patient motivation based on the clinical results to be presented next month.   We are developing plans to complete enrollment within 24 months of first patient randomization.”