The Company will host a corporate update conference call today, on Tuesday, March 24, 2026, at 4:30 PM ET, in which it will discuss business highlights. Call details and dial-in are provided below.
Recent Business Highlights
CardiAMP® autologous cell therapy in ischemic heart failure of reduced ejection fraction (BCDA-01)
In parallel to advancing the regulatory discussions with the USA FDA and Japan PMDA on the potential market release of the CardiAMP System for the treatment of ischemic heart failure, we are advancing the confirmatory CardiAMP HF II Trial.
In October and November, the first enrollment in the CardiAMP HF II clinical study began at University of Wisconsin at Madison and Henry Ford Health System in Detroit MI, respectively. Emory University in Atlanta, GA was also activated as a study site. With BayCare Morton Plant Mease hospital in Clearwater, Florida, four centers are actively enrolling in this study.
In December, Japan's Pharmaceutical and Medical Device Agency (PMDA) granted a preliminary clinical consultation on the acceptability of the existing CardiAMP HF clinical data for submission of an application for approval with post marketing studies. PMDA has subsequently scheduled our formal clinical consultation. In preparation for our formal consultation, we have answered several series of additional thoughtful questions regarding safety and efficacy of the CardiAMP Cell Therapy.
In March, the CardiAMP HF echocardiography clinical results measured by the blinded core laboratory at the Yale University Cardiovascular Research Group were presented at the Late Breaking Clinical trial session at the Technology and Heart Failure Therapeutics conference in Boston, Massachusetts. These results showed positive evidence of decreased pathological left ventricular remodeling over time in patients receiving CardiAMP cell therapy treatment compared to patients not receiving the treatment. These results correlated to findings for the trial primary and key secondary endpoints of reduced fatal and non-fatal major adverse cardiovascular events and improved quality of life measures for treated patients. The Yale core laboratory measured both left ventricular end diastolic volume indices, when the heart ventricle is fully dilated (p = 0.06), and the left ventricular end systolic volume, when the heart is fully contracted (p=0.09). For the prespecified subgroup of patients having elevated biomarkers of heart stress, the differences between the treated and control patients were both clinically meaningful (>20ml/m2 and 15 ml/m2, respectively) and statistically significant (p = 0.02 and p = 0.01, respectively).
This first quarter of 2026, we have submitted the manuscript providing all the details on the CardiAMP HF study for peer review.
In the USA, we expect to soon file a Q-Sub request with FDA Center for Biologics Evaluation and Research (CBER) on approvability of the CardiAMP System based on its safety and signals of benefit in patients with elevated biomarkers of heart stress from our three clinical trials. This discussion is expected to focus on our FDA approved CardiAMP CS cell processing platform to extend labelling to a therapeutic indication for ischemic HFrEF, as its dedicated Helix transendocardial delivery catheter has a Pre-Submission packet actively under review by FDA Center for Devices and Radiological Health (CDRH).
In Japan, we expect to soon have our formal clinical consultation to align with PMDA on the acceptability of the existing clinical data from our three trials for CardiAMP System submission for Shonin approval.
CardiAMP autologous cell therapy in chronic myocardial ischemic with refractory angina (BCDA-02)
Results from the open-label roll-in cohort of patients having chronic myocardial ischemia with refractory angina showed an average 107 second increase in exercise tolerance and an 82% average reduction in angina episodes at the primary six-month follow-up endpoint compared to before receiving the study treatment. Primary results of this cohort were submitted for presentation at Euro PCR, a world-leading course in interventional cardiovascular medicine, in May of 2026.
CardiALLO Cell Therapy in Ischemic Heart Failure (BCDA-03)
The low dose cohort of 20 million cells has been completed and there have been no treatment-emergent adverse events, arrhythmias, rejection, or allergic response. The Data Safety Monitoring Board has recommended that the study proceed as designed based on the 30-day data safety assessment from this cohort.
Phase 2 development is anticipated to be advanced in both the United States and Japan and would also enroll in approximately one year. It is expected that after the completion of this Phase 2 study that conditional approval in Japan may be pursued followed by a post-marketing study over a period of five years to further add to the evidence of safety and patient benefit.
We intend to fund development of our CardiALLO MSC program through nondilutive grants and partnering. The Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs expired September 30, 2025, with our grant application before it. These were reauthorized on March 17th by the House and Senate and are expected to pass into law this month. We are hopeful that this will provide clarity on this funding path for this important program and the technologies that underlie it.
Our clinical grade mesenchymal stem cells are believed to be substantially equivalent and possibly superior to other mesenchymal stem cells currently approved for clinical indications with simple intravenous delivery. The route of administration and dosing are near identical to our approved Investigational New Drug Application for Acute Respiratory Distress Syndrome. We welcome partnering discussions on this cell therapy technology platform and our extensive intellectual property which has applications in indications we are unable to pursue. We have had discussions with other companies with respect to these opportunities.
Helix™ Biotherapeutic Delivery System
In February 2026, we announced a Pre-Submission to FDA under its Q-Submission program for the approval of its Helix Transendocardial Delivery Catheter (Helix) for intramyocardial therapeutic and diagnostic agent delivery. The data supporting safety and effectiveness for the Helix Pre-Submission is from fifteen clinical trials of cell and gene therapy delivery to the heart using Helix, where patients were enrolled in three primary cardiac clinical indications.
FDA has accepted the Helix Pre-Submission and has confirmed that it contains all the necessary elements and information needed to proceed with substantive review. We are scheduled to meet with the FDA in the second quarter of 2026, after receiving written feedback in advance. We expect that the FDA Center for Devices and Radiological Health (CDRH) will lead the review in consultation with the FDA Center for Biologics Evaluation and Research (CBER). The FDA has acknowledged to us that the CBER Breakthrough Designation on Helix enables CardiAMP Cell Therapy for ischemic heart failure.
"We are at an important juncture of advancing our confirmatory CardiAMP HF II trial while we explore approvals based on the strength of the results in our completed trials for our autologous cell therapy for the treatment of ischemic HFrEF," said BioCardia CEO Peter Altman, Ph.D. "The risk benefit profile ...
