BioCardia, Inc.

BioCardia, Inc. is a clinical-stage biotherapeutic company dedicated to developing cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases with significant unmet medical needs. The company's mission is to improve the lives of patients through the development of meaningful therapeutics. BioCardia is headquartered in Sunnyvale, California.

The company's pipeline includes several biotherapeutic platforms and delivery systems. Key product candidates are CardiAMP (an autologous cell therapy) and CardiALLO (an allogeneic cell therapy), targeting indications such as ischemic heart failure with reduced ejection fraction (HFrEF) and chronic myocardial ischemia with refractory angina. BioCardia also develops and provides the Helix Biotherapeutic Delivery System, Morph DNA and AVANCE Steerable Introducers, and the Heart3D fusion imaging platform, which are designed for minimally invasive, targeted delivery of biologic agents to the heart. Additionally, BioCardia partners with other biotherapeutic companies, offering its Helix System and clinical support for their therapeutic programs.

Led by President and CEO Dr. Peter Altman, BioCardia has recently achieved several notable milestones. In April 2026, Japan's Pharmaceuticals and Medical Devices Agency (PMDA) indicated that CardiAMP clinical data for ischemic heart failure is likely sufficient to support market clearance. The company also announced in March 2026 that the FDA accepted its pre-submission package for the Helix Transendocardial Delivery Catheter, with a substantive review and meeting scheduled for Q2 2026. In March 2024, BioCardia entered a partnership with StemCardia to advance a pluripotent stem cell product candidate for heart failure, serving as the exclusive biotherapeutic delivery partner. The CardiAMP cell therapy system previously received FDA Breakthrough Device Designation for heart failure in February 2022.