BioCardia Pauses Enrollment In Late-Stage Study For Heart Failure Study on Monitoring Board Recommendation, Stock Plunges

BioCardia Inc BCDA said 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.

According to the DSMB recommendation, BioCardia is pausing the trial pending the one-year follow-up outcomes analysis for patients treated and those enrolled but not yet treated.

The DSMB recommends notifying currently enrolled patients completing their treatment sequence that the trial will be paused following their scheduled treatment to assess intermediate study results.

The DSMB recommends that the blind not be broken at this time to protect the integrity of the outcomes yet to be collected and to ensure that the study may be restarted without compromise after the completion of the one-year data analysis.

Also Read: BioCardia Outlines Detailed Cell Therapy Data From Heart Failure Study.

The DSMB interim review was based on available data for 132 procedures involving 111 randomized patients, including treated patients and the control group. 

The prespecified statistical analysis plan provided that the DSMB would utilize a composite endpoint that considered survival, major adverse cardiac and cerebrovascular events (MACCE), and a six-minute walk distance at 12 months. 

This is the Finkelstein Schoenfeld (FS) composite endpoint for the study. 

The DSMB reviewed an initial analysis of the unblinded data and concluded that the trial was unlikely to meet its primary FS composite endpoint, even though the prespecified trial termination criteria had not been met. 

This initial analysis excluded patients who had not yet completed the 12-month follow-up. 

The DSMB also cited the slow rate of enrollment in the trial. 

CardiAMP Cell Therapy uses a patient's own (autologous) bone marrow cells delivered to the heart in a minimally invasive, catheter-based procedure to stimulate the body's natural healing response potentially. 

Price Action: BCDA shares are down 45.80% at $1.07 on the last check Monday.