Business
BioCardia Reports Second Quarter 2023 Business Highlights and Financial Results
SUNNYVALE, Calif., Aug. 09, 2023 (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":"SUNNYVALE, Calif., Aug. 09, 2023 (GLOBE NEWSWIRE) -- BioCardia, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today reports financial results for the second quarter of 2023 and filed its quarterly report on Form 10-Q for the three and six months ended June 30, 2023 with the Securities and Exchange Commission. The Company will also hold a conference call at 4:30 PM ET today in which it will discuss business highlights. Following management’s formal remarks, there will be a question-and-answer session. “We have followed the recent recommendation from our Data Safety Monitoring Board (DSMB) to pause enrollment of new patients in our autologous cell therapy trial for ischemic heart failure or BCDA-01, even as there were no treatment emergent safety issues reported, patients in aggregate appear to be showing clinical improvements, and enrollment had accelerated in recent months. We continue to randomize and monitor patients enrolled in this clinical study. Unblinded statistics and clinical consultants are reviewing the primary endpoint analysis and secondary outcome measures. Potential next steps in Q3 include discussions between the DSMB and the consultancies before BioCardia unblinds itself to the interim data,” said Peter Altman PhD. “As we work through this process for BCDA-01, we expect important milestones for our other clinical programs. We look forward to completion of enrollment for the roll-in cohort of the Phase III trial of our autologous cell therapy for patients with chronic myocardial ischemia or BCDA-02, as well as treatment of the first patients in the Phase I/II clinical trial of our allogeneic mesenchymal stem cell therapy for ischemic heart failure or BCDA-03. Business development is active around our Helix biotherapeutic delivery platform and in other areas, and we are working to close two meaningful deals by the end of the year.” RECENT BUSINESS HIGHLIGHTS: CardiAMP® Autologous Cell Therapy for Patients with Ischemic Heart Failure (BCDA-01) The CardiAMP Cell Therapy Trial for Heart Failure is a Phase III, multi-center, randomized, double-blinded, sham-controlled study intended to include up to 260 patients. The Phase III pivotal trial, which was granted Breakthrough designation by the U.S. Food and Drug Administration (FDA),...