BioCardia®?, Inc. announced 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. 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 highability 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 pp/ml and has a modified primary endpoint. This endpoint is nearly identical to other ongoing clinical studies of other therapies for this indication which also utilize NT-proBNP threshold inclusion criteria.

Statistical calculations for this clinical study design support that a modestly sized clinical trial, based on the interim results, would achieve high power (probability of success). Additional modifications to the trial design proposed include elements to simplify clinical logistics and reduce the cost of performing the study. Anticipated Upcoming Mil milestones and Events: BCDA-01: CardiAMP Cell Therapy for Heart Failure Trial(s); Fourth Quarter 2023 CardiAMP HF Trial II FDA Protocol Approval; Fourth 2023: Japan PMDA Formal Consultation; BCDA-02: CardiAMP Cell therapy for Chronic Myocardial Ischemia Phase III Trial; Fourth Fourth 2023: Completion of Roll-in Cohort and Transition to Randomized Pivotal Trial; BCDA-03: NK1R+ MSC Allogeneic Cell Therapy in ischemic HFrEF Phase I/II Trial; Fourth 2023: Com completion of low dose cohort; Helix Biotherapeutic Delivery System; Fourth 2023: Updates on Licensing /Partnerships.