Business
BioCardia Reports Fourth Quarter and Full Year 2022 Business Highlights and Financial Results
SUNNYVALE, Calif., March 29, 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., March 29, 2023 (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, 2022 and filed its annual report on Form 10-K for the year ended December 31, 2022 with the Securities and Exchange Commission. The Company will also hold an update conference call at 4:30 PM ET today in which it will discuss business highlights with call details below. “I am tremendously proud of the BioCardia team and its clinical partners for the regulatory, reimbursement and clinical progress we have made over the last year,” said BioCardia CEO Peter Altman, Ph.D. “We are now advancing four novel autologous and allogeneic cell therapies in clinical studies, each of which is delivered locally to the heart or the lungs, where they are intended to stimulate natural reparative processes and reduce inflammation. This year holds the potential for catalysts that could dramatically improve our prospects, timetable, and attractiveness as a business. We are excited about what the future holds and are grateful for the opportunity in front of us to create an entirely new class of heart failure treatments with the potential to transform cardiovascular and pulmonary care.” RECENT BUSINESS HIGHLIGHTS: CardiAMP® Cell Therapy for Heart Failure (FDA Breakthrough Device Designation) and Chronic Myocardial Ischemia The CardiAMP Cell Therapy Heart Failure Trial (BCDA-01) is a Phase III, 260-patient randomized controlled clinical study intended to provide the primary data to support safety and efficacy in pursuit of market clearance. Data published to date has shown improved functional capacity and quality of life in treated patients. Blinded echocardiography data on the open label roll-in cohort from the core laboratory presented at the American College of Cardiology Annual Meeting in March 2023 showed a 35% improvement in left ventricular ejection fraction over baseline, with 100% survival at two years. Clinical investigators at 22 active partner sites across the United States and Canada have enrolled 119 patients to date, with 10 additional control patients having crossed over to receive therapy after completing their 2-year follow-up study visit. The independent Data Safety Monitor...