BCDA News & Events

BioCardia announced that the Company's Chief Executive Officer, Peter Altman, issued the following letter to shareholders. "Upon completion of our recent capital raise, I am providing this update on our strategy, top priorities, and business development opportunities to ensure understanding and appreciation of what is ahead. This quarter, with Japan's Pharmaceutical and Medical Device Agency's support for potential approval of CardiAMP Cell Therapy for the treatment of ischemic heart failure of reduced ejection fraction, the submission for approval is a top priority. This effort is synergistic with our other important programs... The submission for approval planned for end of 2026 is a meaningful milestone that could be transformative for our business. Strategic partners are expected to view the completed submission as a sign that our product will be in the market soon... Approval in Japan enables expedited registration based on reference country approvals in other regions of the world. Countries in Southeast Asia, Latin America, and the Middle East often designate Japan as a trusted "Reference Country." These countries will often bypass secondary clinical testing, lower their local evaluation timelines, and reduce registration fees for potential distribution partners... We are also driving to enroll the confirmatory CardiAMP HF II Trial in the United States, which the FDA has said may support Premarket Approval.. Near-Term Milestones and Outlook: We are entering a period of high-impact catalysts: Shonin Submission of CardiAMP Cell Therapy to Japan PMDA, Q4 2026; Continued CardiAMP Cell Therapy development in the USA with FDA engagement; Strategic partnership / licensing progress in Helix/Heart3D for cell, gene, and protein delivery to the heart; Strategic partnerships / licensing around our clinical allogeneic MSC platform. We believe these milestones create a compelling opportunity for value creation, particularly considering public market precedents for companies with similar clinical profiles and regulatory positioning."

BioCardia announced receipt of FDA minutes from its Q-Sub Meeting with FDA Center for Biologics Evaluation and Research, or CBER, on the CardiAMP Cell Therapy System for the treatment of ischemic heart failure of reduced ejection fraction. The meeting minutes from FDA confirm that the ongoing CardiAMP Heart Failure II Trial may support premarket approval for market clearance. FDA had previously indicated that they typically like to see two well designed trials for approval, particularly in large clinical indications such as HFrEF, where there are potentially over one million patients who could benefit from CardiAMP Cell Therapy in the United States. FDA has also previously demonstrated that they consider the CardiAMP Cell Therapy System safe, as this FDA determination is required to enable the Centers for Medicare and Medicaid to reimburse in the CardiAMP HF trials.

BioCardia announced the outcome of its pre-submission meeting with FDA on the Helix Transendocardial Delivery Catheter System. FDA agreed that there are two pathways for Helix marketing clearance and raised no concerns on Helix safety data, device performance, or compatibility with general classes of agents. FDA's preferred route of Helix approval was simultaneous with the approval of the CardiAMP cell therapy system for the treatment of heart failure. FDA also suggested a follow-on pre-submission incorporating agency advice could enable Helix approval via the DeNovo pathway.

BioCardia reported a positive outcome in its formal clinical consultation with Japan's Pharmaceutical and Medical Device Agency, PMDA. PMDA has determined that the clinical safety and efficacy evidence for the CardiAMP Cell Therapy in ischemic heart failure is likely sufficient to support market clearance. Good alignment was achieved in the meeting on the acceptability of the foreign clinical data that has been developed in the United States, the indications for use in patients, the approach for introduction of the therapy in Japan, and the need for continued post marketing studies in Japan. The Company will await the minutes from PMDA to provide detailed feedback and timeline for potential filing.