Business
BioCardia Reports 2020 Financial Results and Recent Business Highlights
SAN CARLOS, Calif., March 30, 2021 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [Nasdaq: BCDA], a leader in the development of comprehensive solutions for
About this update from Biocardia, Inc.
[{"type":"text","content":"SAN CARLOS, Calif., March 30, 2021 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [Nasdaq: BCDA], a leader in the development of comprehensive solutions for cardiovascular and pulmonary regenerative therapies, today reported financial results for the fourth quarter and full year ended December 31, 2020 and recent business highlights. BioCardia has filed its annual 10-K with the Securities and Exchange Commission. “We continue to recognize and thank our many outstanding clinical partners and their teams who are on the front lines of dealing with the COVID-19 situation nationwide as we work with them to accelerate our pivotal cell therapy clinical trials,” said BioCardia CEO Peter Altman, Ph.D. “We also recognize the proactive efforts of the FDA to provide guidelines to help protect patients and preserve the integrity of ongoing clinical trials. The ongoing dedication to patient care, even at the potential risk to healthcare workers’ own health, is a testament to the commitment we have seen ourselves in their work on our clinical programs.” Q4 and Recent Business Highlights: CardiAMP™ Cell Therapy CardiAMP™ Heart Failure Trial (BCDA-01) received positive DSMB recommendations – the independent Data Safety Monitoring Board (DSMB) has completed its prespecified data review for the Phase III pivotal CardiAMP™ Heart Failure Trial. The DSMB based its review on all available data for the 86 patients enrolled in the trial, including 60 randomized patients who have reached their one-year follow-up. The DSMB performed a risk-benefit assessment, indicated no safety concerns, and recommended that the study continue as designed. Peer reviewed initial data from the ongoing pivotal Phase III Clinical Trial was in press in the International Journal of Cardiology in October 2020. Results showed improvements at one-year follow-up in heart failure patients measured by exercise outcomes and cardiac function. Helix™ Biotherapeutic Delivery System The journal, Cardiovascular Revascularization Medicine published a study showing the Helix System, which is being used in the pivotal Phase III CardiAMP Heart Failure Trial currently enrolling nationwide for infusion of BioCardia’s CardiAMP cell therapy to the myocardium, demonstrated the best safety profile among clinical transendocardial catheter injection systems used for cardiac cell therapy delivery.U.S. Patent No...