Business
BioCardia Reports Second Quarter 2021 Financial Results and Business Highlights
SAN CARLOS, Calif., Aug. 12, 2021 (GLOBE NEWSWIRE) -- BioCardia, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment
About this update from Biocardia, Inc.
[{"type":"text","content":"SAN CARLOS, Calif., Aug. 12, 2021 (GLOBE NEWSWIRE) -- BioCardia, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today reported financial results for the second quarter of 2021 and filed its quarterly report on Form 10-Q for the three and six months ended June 30, 2021 with the Securities and Exchange Commission. Q2 and Recent Business Highlights: CardiAMP® Autologous Cell Therapy for ischemic heart failure (BCDA-01) The independent Data Safety Monitoring Board (DSMB) completed its fourth prespecified data review for the Phase III pivotal CardiAMP Heart Failure Trial on June 22, 2021. The DSMB preformed a risk-benefit assessment, which typically includes an analysis of futility to reach the primary endpoint of the clinical trial as designed. The DSMB based its review on all available data for the 97 patients enrolled in the trial at that time, 75% of which should have reached their primary clinical endpoint at one-year follow-up. The DSMB indicated no safety concerns and recommended continuing the study as planned.Clinical investigators have enrolled 104 patients. 24 sites are active across the United States.Data was presented at the virtual European Society of Cardiology Heart Failure Annual Meeting 2021 by Dr. Amish Raval on behalf of the CardiAMP Heart Failure trial investigators, demonstrating the high CD34+ cell dosing being achieved in the trial.Continued enrollment and expansion of the trial to additional sites in United States, Canada and Japan is underway. CardiAMP Autologous Cell Therapy for Chronic Myocardial Ischemia (BCDA-02) The pivotal CardiAMP Cell Therapy in Chronic Myocardial Ischemia Trial has been activated and the first patient was consented during the quarter. The Company is working towards initial patient enrollment in the third quarter of 2021. Neurokinin-1 Receptor Positive (NK1R+™) Allogeneic Mesenchymal Cell Therapy (BCDA-03 and 04) BioCardia is working to secure acceptance of Investigational New Drug (IND) applications for Phase I/II trials in ischemic systolic heat failure (BCDA-03) and acute respiratory distress syndrome caused by COVID-19 (BCDA-04) in 2021. The FDA recently provided helpful and positive feedback, including information on required animal testing and clinical trial design. Business Development In A...