BioCardia (BCDA) Corporate presentation summary

Scientific background and mechanism of action

• Bone marrow mononuclear cells, including endothelial progenitor and mesenchymal stem cells, are harvested from the iliac crest and have demonstrated therapeutic benefits for cardiac repair in preclinical and clinical studies.

• These cells act via paracrine mediators, releasing growth factors and cytokines that promote survival, contractility, neovascularization, differentiation, and remodeling of cardiac tissue.

• Microvascular dysfunction, a key factor in heart failure, is targeted by stem cell therapy through mechanisms that counteract fibrosis, inflammation, apoptosis, and endothelial dysfunction.

Preclinical and clinical evidence

• Preclinical studies in rats and pigs show that bone marrow mononuclear cell therapy reduces fibrosis and increases microvessel density in infarcted myocardium, with dose-dependent effects.

• Clinical trials, including the FOCUS-CCTRN and meta-analyses, indicate improved left ventricular ejection fraction (LVEF), reduced mortality, and fewer non-fatal myocardial infarctions and arrhythmias with cell therapy.

CardiAMP therapy process and delivery

• The therapy involves pre-procedure screening to select patients most likely to respond, bone marrow collection, point-of-care cell processing, and targeted transendocardial delivery to peri-infarct myocardial zones.

• Proprietary delivery systems, such as the Helix catheter, enhance myocardial retention and effective dosing compared to other delivery routes.