BioCardia’s Pivotal CardiAMP Cell Therapy Heart Failure Trial Receives Positive DSMB Review With Recommendation to Continue

August 31, 2022—BioCardia, Inc., a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease, announced that the independent Data Safety Monitoring Board (DSMB) has completed its prespecified data review for the ongoing phase 3 pivotal CardiAMP Cell Therapy Heart Failure Trial.

The ongoing multicenter, double-blind, randomized (3:2), controlled pivotal CardiAMP Cell Therapy Heart Failure Trial is expected to enroll 260 patients at up to 40 centers in the United States and Canada. BioCardia initiated the trial in 2017.

According to BioCardia, a risk-benefit assessment indicated no significant safety concerns and the DSMB recommended that the study continue as designed. The board also recommended that BioCardia consider implementing an adaptive statistical analysis plan which could enable an early readout for study treatment efficacy.

The DSMB based its review on available data for all participating patients enrolled in the trial, including 101 patients at or past the 12-month primary endpoint.

BioCardia advised that patient-visit data was available for 93% or more of all patients at all follow-up endpoints. Blinded results across all patients (including treated and control patients) have shown a survival rate at 1 year follow-up that is greater than that observed in recent similar large pivotal trials in patients with heart failure with reduced ejection fraction.

For study patients with follow-up to date through the key visit dates in the study, mean health outcomes across both treated and control patients are demonstrating favorable trends for meaningful clinical improvement. The outcomes include 6-minute walk-distance test, patient status assessed by New York Heart Association class, quality of life measured using the Minnesota Living with Heart Failure questionnaire, and heart function assessment such as left ventricular ejection fraction. It will not be known if there is a difference in outcomes between the two patient study groups enrolled and randomized into the current trial until the data is unblinded and analyzed formally in accordance with the prespecified statistical analysis plan.

The trial’s primary endpoint is an outcomes composite score based on a three-tiered Finkelstein-Schoenfeld hierarchical analysis comparing the occurrence of cardiovascular and other health-related events, along with functional capacity measures, through 1 year in patients receiving the study treatment to patients in the control arm who do not receive the study treatment. Data submitted to the DSMB for review provided the group with visibility into the risks and benefits of the trial at its primary endpoint, noted BioCardia.

In February 2022, the company announced that the FDA granted Breakthrough Device designation for the CardiAmp cell therapy for heart failure. In March, BioCardia announced that the Centers for Medicare & Medicaid Services s designated a new reimbursement code for the CardiAMP cell therapy procedure to transplant autologous bone marrow cells to treat heart failure.