BioCardia Completes Data Verification and Freezes Primary Outcomes Data in Phase 3 CardiAMP HF Study

BioCardia, Inc. announced on February 27, 2025, that it has completed source data verification and frozen the primary outcomes data for its double-blind, randomized, placebo-controlled Phase 3 CardiAMP HF study. The study is evaluating the Company’s autologous, minimally invasive cell therapy aimed at treating patients with ischemic heart failure with reduced ejection fraction (HFrEF).

The press release, issued on the same day, detailed that these key milestones have been reached in the CardiAMP HF study, marking significant progress in the ongoing clinical evaluation of the Company’s therapeutic approach. With the primary outcomes data now frozen, the investigation can move closer to its final analysis phase to better understand the potential benefits of the treatment in addressing the unmet needs in HFrEF patient care.

The completion of source data verification confirms that the data collected during the study have been thoroughly reviewed and meet the necessary quality standards—a critical step prior to the confirmation of study results. This development is expected to inform further discussions with regulators and guide the future clinical development and potential commercialization plans for the therapy.

BioCardia’s achievement in this key phase of the CardiAMP HF study underscores the Company’s ongoing commitment to advancing novel treatments for ischemic heart failure. Further details on the study outcomes will be provided as they become available.

This article was generated by an automated content engine and was reviewed by a human editor prior to publication. For additional information, read BioCardia’s 8K filing here.

About BioCardia

BioCardia, Inc, a clinical-stage regenerative medicine company, develops cellular and cell-derived therapeutics for cardiovascular and pulmonary diseases in the United States. Its lead product candidate is CardiAMP, an autologous mononuclear cell therapy system in Phase III clinical trial for the treatment of ischemic heart failure with reduced ejection fraction and refractory angina resulting from chronic myocardial ischemia.