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BioCardia (NasdaqCM:BCDA) Q4 2025 Earnings call March 24, 2026 04:30 PM ET Company ParticipantsDavid McClung - CFOJames Molloy - Managing DirectorMiranda Peto - Investor Relations RepresentativePeter Altman - President and CEOConference Call ParticipantsNone - AnalystOperatorI would now like to turn the conference over to Miranda Peto of BioCardia Investor Relations. Please go ahead, Miranda.Miranda PetoGood afternoon, and thank you for participating in today's conference call. Joining me from BioCardia's l ...

BioCardia (NasdaqCM:BCDA) Q4 2025 Earnings call March 24, 2026 04:30 PM ET Speaker4I would now like to turn the conference over to Miranda Peto of BioCardia Investor Relations. Please go ahead, Miranda.Speaker3Good afternoon, and thank you for participating in today's conference call. Joining me from BioCardia's leadership team are Peter Altman, President and Chief Executive Officer, and David McClung, the company's Chief Financial Officer. During this call, management will be making forward-looking stateme ...

Recent Business Highlights CardiAMP® autologous cell therapy in ischemic heart failure of reduced ejection fraction (BCDA-01) In parallel to advancing the regulatory discussions with the USA FDA and Japan PMDA on the potential market release of the CardiAMP System for the treatment of ischemic heart failure, we are advancing the confirmatory CardiAMP HF II Trial. ● In October and November, the first enrollment in the CardiAMP HF II clinical study began at University of Wisconsin at Madison and Henry Ford He ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission file number: 001-38999 BIOCARDIA, Inc. (Exact name of registrant as specified in its charter) Delaware 23-2753988 (State or other jurisdiction of incorporation or organization) (I.R.S ...

SUNNYVALE, Calif., March 24, 2026 (GLOBE NEWSWIRE) -- BioCardia, Inc. [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today reported financial results for the year ended December 31, 2025 and filed its annual report on Form 10-K with the Securities and Exchange Commission. The Company will host a corporate update conference call today, on Tuesday, March 24, 2026, at 4:30 PM ET, in which it will discuss business highlights. ...

Core Insights - BioCardia, Inc. will provide a corporate update and report its financial results for the year ended December 31, 2025, on March 24, 2026, at 4:30 PM EDT [1] Company Overview - BioCardia, Inc. is headquartered in Sunnyvale, California, and focuses on developing cellular and cell-derived therapeutics for cardiovascular and pulmonary diseases [4] - The company’s biotherapeutic platforms include CardiAMP® autologous and CardiALLO™ allogeneic cell therapies, aimed at treating heart disease [4] - BioCardia utilizes its Helix™ biotherapeutic delivery and Morph® vascular navigation product platforms to enable these therapies [4] - The company also acts as a biotherapeutic delivery partner for therapies targeting heart failure, chronic myocardial ischemia, and acute myocardial infarction [4]

FDA Substantive Review and Meeting Scheduled for Early Q2SUNNYVALE, Calif., March 17, 2026 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [NASDAQ: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced the FDA has accepted its pre-submission package for the approval of its Helix Transendocardial Delivery Catheter (“Helix”) intended for intramyocardial therapeutic and diagnostic agent delivery. BioCardia has had preliminary meetings wit ...

Core Insights - BioCardia, Inc. has reported promising late-breaking echocardiography results from its Phase III clinical trial for ischemic heart failure with reduced ejection fraction (HFrEF), indicating a potential reduction in negative remodeling of heart volumes in treated patients [1][3]. Clinical Results - The clinical results were presented by Dr. Amish Raval at the Technology and Heart Failure Therapeutics (THT) conference, highlighting the effectiveness of autologous CardiAMP cell therapy in reducing pathological left ventricular remodeling over time compared to control patients [2][3]. - Treated patients showed a statistically significant reduction in left ventricular end diastolic volume (p = 0.06) and left ventricular end systolic volume (p = 0.09), with clinically meaningful differences in a subgroup with elevated biomarkers of heart stress [3][4]. Treatment Implications - CardiAMP treatment is associated with less adverse cardiac remodeling in patients with elevated NTproBNP levels, a biomarker of myocardial stress, suggesting its potential benefits in targeted patient subgroups [4][5]. - The results from the CardiAMP-HF trial indicate a promising avenue for addressing the growing burden of heart failure, particularly as current pharmaceutical options have limited impact [5]. Company Overview - BioCardia is a leader in cellular and cell-derived therapeutics for cardiovascular and pulmonary diseases, with its CardiAMP autologous cell therapy receiving FDA Breakthrough designation [6][7]. - The company is developing three cardiac clinical stage product candidates and utilizes advanced biotherapeutic delivery platforms [7].