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) completed a $4.4 million equity financing, selling 3,509,604 shares at an average price of $1.279 on June 5, 2026. Net proceeds are anticipated to extend the company’s cash runway into the first quarter of 2027, beyond the expected Japan PMDA submission. If currently outstanding warrants from prior financings are exercised for cash, BioCardia anticipates cash runway extending beyond PMDA approval and into initial commercial sales. No new warrants were issued in this capital raise.
BioCardia (Nasdaq: BCDA) reported that FDA minutes from a recent Q-Sub meeting indicate the ongoing CardiAMP Heart Failure II Trial may support Premarket Approval (PMA) of the CardiAMP Cell Therapy System for ischemic heart failure with reduced ejection fraction (HFrEF).
The FDA has previously indicated it typically prefers two well-designed trials for large indications like HFrEF and has already determined the system safe enough to enable Centers for Medicare and Medicaid reimbursement in CardiAMP HF trials.
BioCardia (Nasdaq: BCDA) reported that Japan’s PMDA Consultation Record supports a regulatory submission in Q4 2026 for CardiAMP cell therapy to treat ischemic heart failure with reduced ejection fraction. Alignment was reached on remaining questions, post‑marketing study plans, and collaboration with Japanese academic societies for proper-use guidelines.
About 20,000 of 300,000 Japanese patients may initially qualify. BioCardia targets a seven‑month timeline to file through a Designated Marketing Authorization Holder and is ISO13485 compliant, already manufacturing FDA‑cleared cardiovascular products.
BioCardia (NASDAQ:BCDA) reported preliminary open-label cohort results from the CardiAMP CMI trial in refractory angina, presented at EuroPCR 2026. The minimally invasive autologous cell therapy was well tolerated with no treatment-emergent major adverse cardiac events, improved exercise tolerance by 179 seconds, and reduced angina episodes by 82% at six months, with exercise gains sustained to two years.
BioCardia (Nasdaq: BCDA) will participate virtually in a fireside chat at the A.G.P. Healthcare Company Showcase.
Timing: 11:40 AM ET on Wednesday, May 20, 2026. According to BioCardia, investors can register for the conference and view the session online.
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.