BioCardia Announces Completion of Enrollment in Phase III CardiAMP HF Trial and Plans for CardiAMP HF Trial II

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[{"type":"text","content":"SUNNYVALE, Calif., Oct. 11, 2023 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease, today announces completion of enrollment in its CardiAMP Heart Failure Trial and initiation of a discussion with the FDA on a second pivotal study protocol adapted for the responders in the initial trial with the objective of gaining FDA marketing approval. As previously disclosed, interim trial results reviewed by the Data Safety Monitoring Board (DSMB) in July 2023 indicated that the Phase III CardiAMP Heart Failure trial is not likely to meet the primary endpoint for efficacy at 12 months, in part, because both study groups of randomized patients have had good outcomes. There were no treatment emergent safety concerns by the DSMB. Notably, patients receiving CardiAMP Cell Therapy followed up to 24 months showed a 37% relative risk reduction of cardiac death equivalents and an 18% relative risk reduction in major adverse cardiac and cerebrovascular events (MACCE). For an important subset of patients with higher levels of NT-proBNP, a well-established biomarker of increased heart failure and stress to the heart, the benefits were even greater. In patients with NT-pro BNP levels greater than 500 pg/ml at baseline, an analysis of all available data up to two years shows improvements over controls including a 59% relative risk reduction in mortality [13% reduction in all-cause death and cardiac death equivalents with CardiAMP therapy (9%) over the control group (22%)] and a 54% relative risk reduction of MACCE [21% reduction with CardiAMP therapy (18%) over the control group (39%)]. Further, all clinical outcomes included in this analysis favored therapy including: quality-of-life as measured by the Minnesota Living with Heart Failure Questionnaire, NT-proBNP, Six Minute Walk Distance, left ventricular ejection fraction, left ventricular end systolic volume, and left ventricular end diastolic volume. BioCardia, with its clinical leadership, has developed a modified study design anticipated to have a high probability of success based on existing data and has initiated discussion with the FDA. The proposed CardiAMP Heart Failure II study includes the requirement that all patients have an NT-proBNP at baseline greater than 500 pg/ml and h...

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