BioCardia, Inc.

We are a clinical-stage company focused on developing cellular and cell-derived therapies for cardiovascular and pulmonary diseases. Our primary platform is the CardiAMP® autologous mononuclear cell therapy, which is in clinical development for two cardiac conditions: ischemic heart failure with reduced ejection fraction (HFrEF) and refractory angina due to chronic myocardial ischemia (CMI). This platform targets microvascular dysfunction, aiming to enhance microvascular density and reduce fibrosis. We also have an allogeneic mesenchymal stem cell (MSC) therapy platform, an "off the shelf" cell therapy, in clinical development for ischemic inflammatory HFrEF, based on its immunomodulatory mechanism. While our investigational new drug (IND) for these same cells in acute respiratory distress syndrome has been approved by the FDA, this program has not yet advanced clinically. Our Helix™ transendocardial biotherapeutic delivery system facilitates minimally invasive catheter-based intramyocardial therapeutic delivery for our cardiac candidates. We also partner this delivery platform and offer development services to other companies developing biotherapeutic interventions for local heart delivery. Heart failure, a condition where the heart's blood output is insufficient, affected nearly 6.7 million American adults aged 20 and older in 2024, according to the American Heart Association (AHA). The AHA projects a 55% increase in heart failure prevalence from 2012 to 2030, impacting over 8.5 million people aged 18 and above. The total percentage of the population with HF is projected to rise from 2.4% in 2012 to 3.0% in 2030, with 47% of the effective population estimated to have HFrEF. In 2012, heart failure cost the nation an estimated $30.7 billion.