BioCardia (NASDAQ:BCDA) (NASDAQ: BCDA) is a clinical‐stage biotechnology company focused on the development and commercialization of cell‐based therapies for cardiovascular and pulmonary diseases. The company’s proprietary Helix biotherapeutic delivery system is designed to facilitate precise intramyocardial and intravascular delivery of therapeutic cells or biologics. BioCardia’s lead clinical programs include CardiAMP™ for ischemic heart failure, which employs patients’ own bone marrow‐derived cells to promote neovascularization and improve cardiac function, and CardiALLO™, an off‐the‐shelf allogeneic cell therapy in development for similar indications.
Beyond its core cardiovascular pipeline, BioCardia is exploring additional regenerative medicine applications in pulmonary arterial hypertension and chronic obstructive pulmonary disease. The Helix catheter platform supports these efforts by enabling targeted cell administration to affected tissue beds. The company also offers a suite of development services, including cell processing, quality control and regulatory support, aimed at advancing investigator‐sponsored trials and potential strategic partnerships with larger pharmaceutical and medical device companies.
Founded in 2004 and headquartered in Newark, California, BioCardia has conducted clinical studies across multiple centers in the United States and Europe. The company maintains collaborations with leading academic institutions and clinical investigators to evaluate safety and efficacy outcomes. These multi‐center trials are designed to fulfill regulatory requirements for potential marketing approvals in North America, the European Union and other global markets.
Leadership at BioCardia is headed by President and Chief Executive Officer David Mazzo, who brings more than two decades of experience in life sciences, including previous roles at Becton Dickinson and Novartis. The company’s board and management team combine expertise in interventional cardiology, cell therapy manufacturing, and regulatory affairs. BioCardia continues to advance its clinical programs with the goal of offering new therapeutic options for patients with unmet medical needs in cardiovascular and pulmonary disease.