Business
BioCardia Reports Fourth Quarter and Full Year 2023 Business Highlights and Financial Results
SUNNYVALE, Calif., March 27, 2024 (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., March 27, 2024 (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 year ended December 31, 2023 and filed its annual report on Form 10-K 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 with call details below. “Heart failure of reduced ejection fraction or HFrEF remains an unmet clinical need with none of the recently approved therapies reducing mortality,” said BioCardia CEO Peter Altman, Ph.D. “The interim data from our CardiAMP Heart Failure trial, where we missed the primary endpoint, shows reduced heart death equivalents, reduced major adverse cardiac events, reduced cardiac arrhythmias, and enhanced heart function in treated patients relative to the control patients. These results and their remarkable subgroup outcomes in patients with active heart failure underlie the potential to help millions of patients should they be confirmed.” Dr. Altman continued, “In 2024, we aim to complete the study follow-up, seek approval in Japan, and advance the confirmatory CardiAMP Heart Failure II Trial. We also intend to advance our earlier biotherapeutic product candidates, while securing meaningful value from our supportive Helix™ Biotherapeutic Delivery and Morph Access Innovations businesses.” RECENT BUSINESS HIGHLIGHTS: CardiAMP® Autologous Cell Therapy for Ischemic HFrEF (BCDA-01) The CardiAMP Cell Therapy Heart Failure Trial Study enrollment in the randomized double-blind controlled trial, which has both FDA breakthrough designation and Medicare coverage, was completed during the fourth quarter of 2023 as the study was unlikely to be able to meet the primary endpoint as designed.The interim results on 110 randomized patients were presented at the Technology and Heart Failure Therapy meeting in March 2024 and showed treated patients appeared to benefit in the two most important tiers of the primary composite endpoint. Treated patients had a 37% relative risk reduction in heart death equivalent (all cause death, heart transplantation, and left ventricular assist device implantation) and a 9% reduction in non-fatal major adverse cardiac and cerebrovascular ...