BioCardia Announces Fourth Positive DSMB Review and Recommendation to Continue Phase III Pivotal CardiAMP Cell Therapy Heart Failure Study as Designed

Excerpt from the Press Release:

SAN CARLOS, Calif., June 23, 2021 (GLOBE NEWSWIRE) — BioCardia®, Inc. [Nasdaq: BCDA], a company focused on developing cellular and cell derived therapeutics for the treatment of cardiovascular and pulmonary disease, today announces that the independent Data Safety Monitoring Board (DSMB) has completed its prespecified data review for the Phase III pivotal CardiAMP™ Cell Therapy Heart Failure Trial (ClinicalTrials.gov Identifier: NCT02438306). The DSMB based its review on all available data for the 97 patients enrolled in the trial to date, including many who have reached their one-year, and a few who have reached their two-year, follow-up. The DSMB performed a risk-benefit assessment, indicated no safety concerns, and recommended that the study continue as designed.  

“This DSMB recommendation to continue the Phase 3 study suggests we are still heading in the right direction from both a safety and efficacy perspective,” said BioCardia CEO Peter Altman, PhD. “CardiAMP Cell Therapy HF Trial enrollment remains a top priority as we begin to have the first control patients eligible for cross over to receive therapy. An earlier cross over recently approved by the FDA based on previous DSMB reviews, provides control patients with a much higher level of assurance that if they are eligible for the investigational therapy, they will be able to receive it after two years. This is good news for patients who participate out of the goodness of their hearts to contribute to the advancement of medical care and for the chance of receiving potential benefits to their own hearts from the CardiAMP investigational cell therapy.”

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