BioCardia Inc (NASDAQ: BCDA) is a clinical-stage biotherapeutics company developing cell therapy systems for cardiovascular disease. The company has generated no meaningful commercial revenue as of December 31, 2025, and has funded operations through equity and convertible debt sales, accumulating a deficit of approximately $168.3 million since inception. Its two primary therapeutic platforms are the autologous CardiAMP Cell Therapy System, targeting heart failure and chronic myocardial ischemia, and an allogeneic mesenchymal stem cell platform with two FDA-approved INDs targeting ischemic heart failure with reduced ejection fraction (BCDA-03) and acute respiratory distress (BCDA-04). CardiAMP trials have received CMS Medicare national coverage designation, with covered costs up to $17,500 per patient for treatment and control arms. BioCardia manufactures allogeneic cells at its Sunnyvale, California facility, certified for manufacturing in 2022. Cash and cash equivalents stood at approximately $2.5 million as of December 31, 2025, with cash used in operating activities of approximately $7.4 million for the year ended December 31, 2025.

Revenue model

BioCardia has no commercial product revenue as of December 31, 2025. The company describes a target recurring revenue model based on biotherapeutic delivery partnering, but this has not yet generated meaningful revenue. Operations are financed through equity sales, including an at-the-market facility with HCW with approximately $5.1 million remaining as of March 24, 2026, plus potential future licensing, collaboration, and government funding arrangements.

Products and services

CardiAMP Cell Therapy System (autologous, targeting heart failure and chronic myocardial ischemia); CardiAMP HF and CardiAMP HF II clinical trials; CardiALLO allogeneic MSC therapy for ischemic heart failure with HFrEF (BCDA-03); allogeneic MSC therapy for acute respiratory distress (BCDA-04); proprietary biotherapeutic delivery platform intended for partnering.

Customers and end markets

Target end markets are interventional cardiologists and cardiologists treating heart failure and chronic myocardial ischemia in the United States. CMS Medicare coverage applies to CardiAMP trial participants, with private insurers covering approximately 50 million Americans anticipated to follow CMS policy. No commercial customers as of December 31, 2025.

Value-chain role

Clinical-stage developer and manufacturer of cell therapy products. BioCardia manufactures allogeneic MSC cells internally at its Sunnyvale facility and relies on third-party vendors for certain components and sub-assemblies. Plans to commercialize approved products through an internal sales force directed at cardiologists and third-party payors in the United States.

Geographic exposure

Operations based in Sunnyvale, California. Regulatory references include U.S. FDA jurisdiction and European Economic Area medical device regulations, indicating anticipated international activity, though no commercial geographic revenue mix is disclosed in the filing excerpts.

Source: SEC 10-K, filed 2026-03-24

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