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. develops cellular and cell-derived therapeutics for cardiovascular and pulmonary diseases. Its recurring company updates center on the CardiAMP autologous cell therapy platform, CardiALLO allogeneic cell therapy programs, and device and software technologies used to deliver therapies to the heart, including the Helix transendocardial delivery catheter and Heart3D Fusion Imaging software.
News about BCDA commonly covers clinical results in ischemic heart failure with reduced ejection fraction, FDA and Japan PMDA regulatory interactions, patent protection for procedure-planning and navigation technology, and annual financial results. Company communications also address the role of Helix and related vascular navigation platforms in minimally invasive intramyocardial delivery of therapeutic and diagnostic agents.
BioCardia (Nasdaq: BCDA) reported first quarter 2026 results and regulatory progress for its CardiAMP cell therapies and Helix delivery system.
Net loss narrowed to about $2.3 million with lower R&D and SG&A, cash used in operations was $1.7 million, and quarter-end cash totaled $951,000.
Regulators in Japan and the US provided supportive feedback toward potential CardiAMP and Helix approvals.
BioCardia (NASDAQ:BCDA) will host a Q1 2026 financial results and corporate update conference call on May 15, 2026 at 4:30 PM EDT. The event includes management remarks and a Q&A session, with access via phone registration or live webcast and replay options.
BioCardia (Nasdaq: BCDA) reported FDA alignment on clearance pathways for the Helix Transendocardial Delivery Catheter. FDA agreed there are two potential routes to market, raised no concerns about Helix safety, device performance, or compatibility with broad agent classes, and preferred simultaneous approval with CardiAMP.
FDA also suggested a follow-on pre-submission could enable Helix approval via the DeNovo pathway.
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).