Welcome to our dedicated page for Biocardia news (Ticker: BCDA), a resource for investors and traders seeking the latest updates and insights on Biocardia stock.
BioCardia, Inc. (NASDAQ: BCDA) generates news centered on its development of cellular and cell-derived therapeutics for cardiovascular and pulmonary disease. As a clinical-stage company headquartered in Sunnyvale, California, its updates often relate to progress in late-stage trials, regulatory interactions, and advances in its enabling delivery and imaging technologies.
Investors and clinicians following BCDA news can expect regular coverage of the CardiAMP autologous cell therapy platform in ischemic heart failure with reduced ejection fraction (HFrEF) and chronic myocardial ischemia with refractory angina, as well as the CardiALLO allogeneic mesenchymal stem cell platform in ischemic heart failure. Recent announcements have highlighted Phase 3 CardiAMP HF II trial enrollment at leading centers, subgroup efficacy signals from prior trials, and discussions with Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) on the potential approvability of CardiAMP Cell Therapy for HFrEF.
News items also address BioCardia’s Helix transendocardial biotherapeutic delivery system, Morph vascular navigation platform, and Heart3D fusion imaging platform, including updates on planned regulatory submissions and performance in preclinical and clinical settings. Corporate developments such as leadership appointments, board changes, financing activities, and Nasdaq listing compliance updates are disclosed through press releases and corresponding SEC filings.
This BCDA news page brings together these announcements so readers can follow clinical milestones, regulatory consultations, device platform progress, and governance developments in one place. For those tracking investigational therapies in heart failure, refractory angina, and related conditions, the BioCardia news feed provides an ongoing view into how the company’s programs and platforms are evolving over time.
BioCardia (Nasdaq: BCDA) announced allowance of a Japanese patent titled “Target Site Selection, Entry, and Update with Automatic Remote Image Annotation” on April 28, 2026. The patent covers the company’s Heart3D™ Fusion Imaging software for preoperative 3D-to-2D image transposition, intraoperative 3D model reconstruction, procedure planning, and real-time navigation within or adjacent to a sterile field.
BioCardia said Heart3D is intended to support CardiAMP® cell therapy and the Helix™ intramyocardial delivery system, and the company is working to submit these product candidates for approval in Japan after a positive PMDA consultation and is discussing U.S. approval pathways.
BioCardia (Nasdaq: BCDA) reported on April 20, 2026 that Japan’s PMDA found the CardiAMP clinical safety and efficacy data likely sufficient to support market clearance for ischemic heart failure. The meeting achieved alignment on acceptability of U.S. clinical data, indications, introduction approach in Japan, and required post‑marketing studies. The company will await PMDA meeting minutes for detailed feedback and a potential filing timeline.
BioCardia said the consultation included unanimous clinician support and affirmed progress toward a first minimally invasive biologic therapy approval in Japan.
BioCardia (Nasdaq: BCDA) submitted CardiAMP HF clinical study data and requested an FDA meeting to discuss an accelerated approval pathway for the CardiAMP System in ischemic HFrEF. The meeting is expected this quarter under the device's Breakthrough Designation.
Key data: 125 ischemic HFrEF patients enrolled; subgroup with elevated heart-stress biomarkers showed a 47% relative reduction in all-cause cardiac death, 37% relative reduction in non-fatal major adverse cardiac events, and quality-of-life improvement (p=0.04). Results were presented at THT 2026.
BioCardia (Nasdaq: BCDA) reported 2025 results and business highlights on March 24, 2026, and filed its 2025 Form 10-K. Key clinical advances include enrollment starts in the CardiAMP HF II trial, PMDA preliminary clinical consultation in Japan, FDA acceptance of a Helix Pre-Submission, and Yale core‑lab echocardiography results showing reduced pathological remodeling in treated patients.
Financially, net cash used in operations was approximately $7.4M, cash and cash equivalents were approximately $2.5M, R&D expenses were $5.0M, and the net loss was approximately $8.2M for 2025.
BioCardia (NASDAQ:BCDA) will report 2025 financial results and provide a corporate update on a conference call on March 24, 2026 at 4:30 PM EDT. The event includes management remarks and a Q&A, with live webcast access and replay availability through June 24, 2026.
Registered participants receive dial-in details; domestic and international phone numbers and replay instructions are provided for listeners.
BioCardia (NASDAQ: BCDA) announced that the FDA accepted its pre-submission package for the Helix Transendocardial Delivery Catheter on March 17, 2026. A substantive review and an FDA meeting are scheduled for early Q2, with CDRH expected to lead review in consultation with CBER.
CDRH acknowledged CBER's CardiAMP Cell Therapy Breakthrough Designation enabled by Helix. Company leadership said FDA clearance of Helix could materially support minimally invasive intramyocardial delivery and potentially streamline approval for its CardiAMP cell therapy for ischemic heart failure.
BioCardia (Nasdaq: BCDA) presented late‑breaking echocardiography results from the Phase III CardiAMP HF trial on March 3, 2026 at THT. Core‑lab measured left ventricular volumes showed treated patients had less adverse remodeling overall and statistically significant, clinically meaningful volume reductions in a prespecified subgroup with elevated NTproBNP.
For that subgroup differences exceeded 20 ml/m2 (LVEDV) and 15 ml/m2 (LVESV) with p=0.02 and p=0.01, respectively; overall LVEDV and LVESV comparisons were not statistically significant (p=0.06 and p=0.09).
BioCardia (Nasdaq: BCDA) completed a Pre-Submission to FDA under the Q-Submission program seeking approval of its Helix Transendocardial Delivery Catheter for intramyocardial therapeutic and diagnostic delivery.
Support includes safety and effectiveness data from 15 well-controlled clinical trials across three primary cardiac indications. BioCardia aims to align with FDA on the regulatory pathway and timing within 45 days, with a market clearance application to follow.
BioCardia (NASDAQ: BCDA) announced that echocardiography data from the CardiAMP HF trial has been accepted for a Late Breaking Clinical Trial Oral Presentation at Technology and Heart Failure Therapeutics (THT) in Boston, March 2-4, 2026.
Dr. Amish Raval will present the late-breaking echocardiography results on March 2 at 2:00 PM ET, focusing on autologous cell therapy and ventricular remodeling in chronic ischemic HFrEF patients selected for favorable cell characteristics.
BioCardia (NASDAQ: BCDA) completed a third preliminary clinical consultation with Japan’s PMDA on CardiAMP Cell Therapy for ischemic heart failure (HFrEF) on Dec 16, 2025. PMDA indicated BioCardia may advance to a formal clinical consultation to assess whether existing clinical data are acceptable for a regulatory submission in Japan. The company says its compiled Phase I, II and III data show favorable safety and efficacy signals, including improved survival, reduced major adverse cardiovascular events, and better heart function and quality of life versus controls. The data remain subject to ongoing regulatory discussions in Japan and the United States, and a formal PMDA determination would be required before a Japan regulatory filing.