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 second quarter 2026 results and regulatory progress for its cardiovascular cell therapies and enabling technologies.
Japan’s PMDA indicated support for a Shonin pre-market submission of CardiAMP Cell Therapy for ischemic heart failure based on three completed trials, while requesting additional data on guideline-directed medical therapy, revascularization eligibility and serious outcomes. The U.S. FDA informed BioCardia that the ongoing CardiAMP HF II trial may support a Premarket Approval filing. FDA also indicated De Novo approval of the Helix transendocardial delivery catheter is possible following a May pre-submission meeting.
In refractory angina, EuroPCR data showed the CardiAMP procedure was well-tolerated, with average exercise time improving 179 seconds and angina episodes reduced by 82% at six months, sustained to two years. Financially, Q2 operating cash use was $1.7 million; BioCardia raised $4.9 million via its ATM, ending with $4.1 million in cash and cash equivalents and reporting a narrower quarterly net loss of $1.6 million.
BioCardia (NASDAQ:BCDA) will host a conference call on Wednesday, August 12, 2026 at 4:30 PM EDT to provide a corporate update and report its Q2 2026 financial results. The event will include prepared remarks followed by a question-and-answer session.
Participants can register online to receive dial-in details or join by phone at 1-833-316-0559 (U.S.) or 1-412-317-5730 (international). A live webcast and both webcast and telephonic replays will be available, with webcast replay access through approximately November 12, 2026.
BioCardia (Nasdaq: BCDA) outlined 2026 priorities following a recent financing. The company is preparing a Shonin submission to Japan’s PMDA for CardiAMP cell therapy for ischemic heart failure, targeting an initial 20,000-patient subgroup within a 300,000-patient population, with precedent reimbursement of $124,000 per procedure.
Additional priorities include enrolling the U.S. CardiAMP HF II trial, advancing the Helix/Heart3D delivery platform, progressing allogeneic MSC programs with two FDA-cleared INDs, and pursuing partnerships. The financing is expected to fund the Japan submission, U.S. enrollment, and pipeline discussions.
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.