BioCardia Announces Positive DSMB Review and Recommendation to Continue Phase III Pivotal CardiAMP Cell Therapy Heart Failure Trial
BioCardia, Inc. (BCDA)
US:NASDAQ Investor Relations:
biocardia.com/investors/press-releases/id/1037?pressreleaseid=41
Company Research
Source: GlobeNewswire
Adaptive Statistical Analysis Plan Recommended SUNNYVALE, Calif., Aug. 31, 2022 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [Nasdaq: BCDA], a developer of 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 ongoing Phase III pivotal CardiAMP® Cell Therapy Heart Failure Trial (clinicaltrials.gov Identifier: NCT02438306), for which FDA granted Breakthrough Designation earlier this year. The DSMB based their review on available data for all participating patients enrolled, including 101 patients at or past the 12-month primary endpoint. The DSMB performed a risk-benefit assessment, indicated no significant safety concerns, and recommended that the study continue as designed. The DSMB also recommended that BioCardia consider implementing an adaptive statistical analysis plan which could enable an early readout for study treat
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News
- BioCardia Reports Fourth Quarter and Full Year 2023 Business Highlights and Financial Results [Yahoo! Finance]Yahoo! Finance
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- BioCardia to Host 2023 Financial Results and Corporate Update Conference Call on March 27, 2024 [Yahoo! Finance]Yahoo! Finance
- BioCardia to Host 2023 Financial Results and Corporate Update Conference Call on March 27, 2024GlobeNewswire
- BioCardia and StemCardia partners for heart failure treatment candidate [Seeking Alpha]Seeking Alpha
BCDA
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- 11/8/23 - In-Line
BCDA
Sec Filings
- 3/27/24 - Form S-8
- 3/27/24 - Form 8-K
- 3/27/24 - Form 10-K
- BCDA's page on the SEC website