BioCardia Announces Activation of CardiAMP Heart Failure II Phase 3 Pivotal Study Recently Approved by FDA
BioCardia, Inc. (BCDA)
US:NASDAQ Investor Relations:
biocardia.com/investors/press-releases/id/1037?pressreleaseid=41
Company Research
Source: GlobeNewswire
SUNNYVALE, Calif., Feb. 08, 2024 (GLOBE NEWSWIRE) -- BioCardia, Inc. (“BioCardia” or the “Company”) (Nasdaq: BCDA), a biotechnology company focused on advancing late-stage cell therapy interventions for cardiovascular disorders, is targeting heart failure and chronic myocardial ischemia as potential indications for its biotherapeutic candidates: autologous CardiAMP® cell therapy and allogeneic CardiALLO™ cell therapy. The Company announces activation of CardiAMP HF II, a randomized controlled pivotal trial of its CardiAMP autologous cell therapy for patients with ischemic heart failure. The study was approved by FDA in Q4 2023 for the treatment of ischemic etiology heart failure of reduced ejection fraction (HFrEF). Study activation includes study-wide Institutional Review Board (IRB) approval for proceeding with the study as well as formally addressing the many requirements of performing a double blinded randomized controlled multi center interventional biotherapeutic study. The
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News
- BioCardia’s CardiAMP Cell Therapy Chronic Myocardial Ischemia Trial Results Show Patient Benefits in Important OutcomesGlobeNewswire
- BioCardia Completes Enrollment of CardiAMP Cell Therapy for the Treatment of Chronic Myocardial Ischemia Trial Open Label Roll-In Cohort [Yahoo! Finance]Yahoo! Finance
- BioCardia Completes Enrollment of CardiAMP Cell Therapy for the Treatment of Chronic Myocardial Ischemia Trial Open Label Roll-In CohortGlobeNewswire
- BioCardia, Inc. (NASDAQ:BCDA) Q4 2023 Earnings Call Transcript [Yahoo! Finance]Yahoo! Finance
- BioCardia Reports Fourth Quarter and Full Year 2023 Business Highlights and Financial Results [Yahoo! Finance]Yahoo! Finance
BCDA
Earnings
- 11/8/23 - In-Line
BCDA
Sec Filings
- 5/1/24 - Form 8-K
- 4/19/24 - Form 4
- 4/15/24 - Form DEF
- BCDA's page on the SEC website