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), a cardiovascular and pulmonary therapeutics company, has successfully regained compliance with Nasdaq Capital Market's Listing Requirements. The company received official confirmation from Nasdaq on October 1, 2025, verifying its compliance with Listing Rule 5550(b)(1), known as the Equity Rule.
This achievement follows BioCardia's efforts to strengthen its balance sheet through capital raising initiatives, which will support the continued development of its therapeutic candidates and advancement of approved products. The company's securities will maintain their listing on the Nasdaq Capital Market under the symbol "BCDA".
BioCardia (NASDAQ:BCDA), a cardiovascular and pulmonary therapeutics developer, has completed a positive preliminary clinical consultation with Japan's Pharmaceutical and Medical Device Agency (PMDA) regarding their CardiAMP Heart Failure Trial results.
The PMDA has requested additional information about the trial's prespecified composite endpoints, statistical power, and the NTproBNP subgroup's risk-benefit profile. The company plans to submit responses and anticipates a formal clinical consultation by year-end.
The consultation covers three completed clinical trials involving 178 ischemic heart failure patients, focusing on those with limited therapeutic options who showed significant benefits from BioCardia's autologous minimally invasive cell therapy.
BioCardia (NASDAQ:BCDA), a cardiovascular and pulmonary disease therapeutics developer, has announced a $12 million public offering. The offering consists of 4.8 million shares of common stock and short-term warrants at a combined price of $1.25 per share and warrant.
The initial offering will raise $6 million in gross proceeds, with potential for an additional $6 million if all warrants are exercised. The warrants have an exercise price of $1.25 per share and a two-year expiration period. H.C. Wainwright & Co. serves as the exclusive placement agent, with closing expected around September 19, 2025.
Proceeds will support working capital and general corporate purposes, including advancement of BioCardia's investigational biotherapeutic candidates and delivery partnering business.
BioCardia (NASDAQ: BCDA) reported positive top-line data from the roll-in cohort of its CardiAMP® Cell Therapy trial in Chronic Myocardial Ischemia patients. The study demonstrated that patients experienced an average 80-second increase in exercise tolerance and an 82% reduction in angina episodes at the six-month primary endpoint.
The minimally-invasive procedure showed promising results with 60% of patients experiencing substantial improvements in both measures. The therapy was well-tolerated with no treatment emergent major adverse cardiac events, and results compared favorably to current FDA-approved therapies like Ranolazine and Enhanced External Counter Pulsation (EECP).
BioCardia (NASDAQ:BCDA), a cardiovascular and pulmonary therapeutics developer, announces CEO Peter Altman's upcoming presentation at the H.C. Wainwright Global Investment Conference on September 10, 2025. The presentation will focus on three key areas: the company's clinical cell therapy programs for ischemic heart disease, regulatory progress for CardiAMP® cell therapy and Helix™ delivery catheter with FDA and Japan PMDA, and recent developments including the Heart3D fusion imaging partnership and CardiALLO program funding.
Dr. Altman will present at 2:00 PM ET at the Lotte Palace Hotel in New York City and will be available for one-on-one meetings with investors during the conference, which runs from September 8-10, 2025.
BioCardia (NASDAQ:BCDA) and CART-Tech have formed an exclusive partnership to develop and commercialize Heart3D™ Fusion Imaging technology for cardiac interventions. The system enhances 2D x-ray images by fusing them with annotated 3D heart models from MRI and CT scans.
Under the agreement, BioCardia secures exclusive worldwide distribution rights for biotherapeutic delivery and U.S. rights for cardiac biopsy. Management estimates that a single approved biologic therapy could generate $100 million in annual revenue if Heart3D becomes the standard of care. The system will initially launch as a research tool before seeking approval for clinical practice.
BioCardia (NASDAQ:BCDA) reported Q2 2025 financial results and significant progress in its cardiovascular therapeutics pipeline. The company's flagship CardiAMP HF Trial showed promising two-year results, with treatment groups demonstrating lower incidence of death and complications, particularly significant in patients with elevated NTproBNP (p=0.02).
Financial highlights include increased R&D expenses to $1.4M in Q2 2025, a net loss of $2.0M, and a current cash balance of approximately $1.1M providing runway into October 2025. The company strengthened its intellectual property portfolio with a new US patent for its biotherapeutic delivery catheter systems.
Key upcoming milestones include FDA meetings on CardiAMP HF approvability in Q4 2025, Japan PMDA clinical review, and planned FDA submission for the Helix biotherapeutic delivery system in Q3 2025.
BioCardia (NASDAQ:BCDA), a company focused on developing cellular and cell-derived therapeutics for cardiovascular and pulmonary diseases, will host its Q2 2025 earnings conference call on August 11, 2025 at 4:30 PM ET.
The company will provide a corporate update and discuss financial results for the quarter ended June 30, 2025. The call will include management remarks followed by a Q&A session. Participants can join through a dial-in number after registration or via webcast.
BioCardia (NASDAQ:BCDA) has outlined its regulatory timeline for seeking approvals of its CardiAMP® Cell Therapy System and Helix™ Transendocardial Delivery Catheter from both FDA and Japan PMDA. The company plans to submit a DeNovo 510(k) application for the Helix system in Q3 2025, backed by safety data from over 4,000 intramyocardial deliveries.
In Q4 2025, BioCardia will request an FDA meeting to discuss CardiAMP Cell Therapy's approval for heart failure treatment, supported by its Breakthrough Designation status and clinical trial results. Simultaneously, the company expects an in-person consultation with Japan's PMDA regarding CardiAMP system approval, potentially benefiting from Japan's adaptive framework for regenerative medical products.
BioCardia (NASDAQ:BCDA) has submitted its CardiAMP autologous cell therapy for clinical consultation with Japan's Pharmaceuticals and Medical Devices Agency (PMDA). The submission includes comprehensive clinical data from the completed CardiAMP HF trial and the principal clinical portion of the Summary Technical Documentation (STED).
The PMDA consultation will evaluate the therapy's efficacy and safety data, assess target patient populations, and determine its fit within Japan's heart failure treatment landscape. A successful review could enable BioCardia to pursue market approval in Japan, potentially leading to a post-marketing study in 2026.