DSMB recommends continuation of BioCardia's cell therapy trial for heart failure [Yahoo! Finance]
BioCardia, Inc. (BCDA)
US:NASDAQ Investor Relations:
biocardia.com/investors/press-releases/id/1037?pressreleaseid=41
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Source: Yahoo! Finance
The decision comes after an assessment of 30-day safety data from subjects who were treated in the trial's low-dose 20 million cell cohort. This data did not show any treatment-emergent adverse cardiac events or immune reactions to the implanted allogeneic cells. Following the DSMB's approval, BioCardia aims to advance the study by enrolling 39 subjects across the US. The trial aims to explore the efficacy and safety of mesenchymal stromal/stem cells (MSCs) in treating heart failure. It involves a nine-patient, open-label Phase I dose escalation cohort, followed by a randomised placebo procedure-controlled double-blinded 30-patient cohort. In Phase I of the trial, three subjects will receive treatments at dosages of either 20 million, 100 million and 200 million cells. These treatments will be administered using the Helix delivery system, which is designed to be minimally invasive. BioCardia said that at high dosage levels, the CardiALLO-HF trial will provide at least t
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BCDA
News
- BioCardia Cell Therapy for Ischemic Heart Failure to Progress to Formal Clinical Consultation with Japan PMDAGlobeNewswire
- BioCardia Announces Election of New Board Director, Marvin Slosman and Completion of Term for Outgoing Director, Dr. Richard Krasno [Yahoo! Finance]Yahoo! Finance
- BioCardia Announces Election of New Board Director, Marvin Slosman and Completion of Term for Outgoing Director, Dr. Richard KrasnoGlobeNewswire
- BioCardia to Present at December 2025 CSI Focus Devices in Heart Failure CongressGlobeNewswire
- BioCardia Strengthens Leadership Team with The Addition of Farhan Shahab as Vice President of QualityGlobeNewswire
BCDA
Analyst Actions
- 9/22/25 - HC Wainwright
BCDA
Sec Filings
- 12/18/25 - Form S-8
- 12/17/25 - Form 4
- 12/16/25 - Form 8-K
- BCDA's page on the SEC website