Business
BioCardia Reports Third Quarter 2020 Financial Results and Business Highlights
SAN CARLOS, Calif., Nov. 10, 2020 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [NASDAQ: BCDA], a leader in the development of autologous and allogenic cell therapies,
About this update from Biocardia, Inc.
[{"type":"text","content":"SAN CARLOS, Calif., Nov. 10, 2020 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [NASDAQ: BCDA], a leader in the development of autologous and allogenic cell therapies, today reported financial results and business highlights for the third quarter of 2020 and filed its quarterly report on Form 10-Q for the three and nine months ended September 30, 2020 with the Securities and Exchange Commission on November 10, 2020.\n The Company is advancing its autologous and allogenic bone marrow-derived cell therapies for three cardiovascular indications and one respiratory indication. Third Quarter 2020 Business Highlights: Autologous Cell Therapies BCDA-01: Patient enrollment in the Phase III pivotal trial of the investigational CardiAMP® cell therapy for the treatment of heart failure continued as centers slowly emerge from the challenges related to COVID-19. As of today, 81 patients have been randomized, four patients are being scheduled for treatment after passing screening with the cell potency assay, and nine additional patients have recently been consented and are actively being screened. Clinical sites remain engaged and momentum is resuming for these elective enrollment activities. Data transfer for the DSMB review scheduled for December 15th has been completed. The anticipated DSMB review in the fourth quarter of 2020, including the risk benefit analysis of 60 patients at their primary endpoint, appears to be on track.BCDA-02: A second clinical application of CardiAMP cell therapy for the treatment of chronic myocardial ischemia is also advancing in an FDA-approved pivotal trial, which is also being reimbursed by the Centers for Medicaid and Medicare Services (CMS). The Company began the third quarter by activating this trial at the University of Florida as the first clinical site. Four additional sites are in active contracting and budget negotiations. Enrollment of the first patient in this trial in the fourth quarter of 2020 appears to be on track. Allogenic Cell Therapies BCDA:03: Development continued in the CardiALLO™ neurokinin-1 receptor positive (NK1R+) mesenchymal stem cell (MSC) program targeted to treat patients with heart failure who are ineligible for the Company’s autologous cell therapy due to their cell potency assay score. After responding to FDA comments on the Investigational New Drug Application in the second quarter o...