Business
BioCardia Reports 2025 Business Highlights and Financial Results
SUNNYVALE, Calif., March 24, 2026 (GLOBE NEWSWIRE) -- BioCardia, Inc. [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the
About this update from Biocardia, Inc.
[{"type":"text","content":"SUNNYVALE, Calif., March 24, 2026 (GLOBE NEWSWIRE) -- BioCardia, Inc. [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today reported financial results for the year ended December 31, 2025 and filed its annual report on Form 10-K with the Securities and Exchange Commission. The Company will host a corporate update conference call today, on Tuesday, March 24, 2026, at 4:30 PM ET, in which it will discuss business highlights. Call details and dial-in are provided below. Recent Business Highlights CardiAMP® autologous cell therapy in ischemic heart failure of reduced ejection fraction (BCDA-01) In parallel to advancing the regulatory discussions with the USA FDA and Japan PMDA on the potential market release of the CardiAMP System for the treatment of ischemic heart failure, we are advancing the confirmatory CardiAMP HF II Trial. In October and November, the first enrollment in the CardiAMP HF II clinical study began at University of Wisconsin at Madison and Henry Ford Health System in Detroit MI, respectively. Emory University in Atlanta, GA was also activated as a study site. With BayCare Morton Plant Mease hospital in Clearwater, Florida, four centers are actively enrolling in this study.In December, Japan’s Pharmaceutical and Medical Device Agency (PMDA) granted a preliminary clinical consultation on the acceptability of the existing CardiAMP HF clinical data for submission of an application for approval with post marketing studies. PMDA has subsequently scheduled our formal clinical consultation. In preparation for our formal consultation, we have answered several series of additional thoughtful questions regarding safety and efficacy of the CardiAMP Cell Therapy.In March, the CardiAMP HF echocardiography clinical results measured by the blinded core laboratory at the Yale University Cardiovascular Research Group were presented at the Late Breaking Clinical trial session at the Technology and Heart Failure Therapeutics conference in Boston, Massachusetts. These results showed positive evidence of decreased pathological left ventricular remodeling over time in patients receiving CardiAMP cell therapy treatment compared to patients not receiving the treatment. These results correlated to findings for the trial primary and key secondary endpoints...