BioCardia, Inc. has reported its financial results for the fiscal year ending December 31, 2025, revealing a net loss of $8.2 million, an increase from a loss of $7.9 million in the previous year. The company's total revenue for 2025 was $0, a decline from $58,000 in 2024, primarily due to the timing of collaboration revenues, which are dependent on partner development activities. Research and development expenses rose to approximately $5 million, up from $4.4 million in 2024, driven by activities related to the CardiAMP Heart Failure Trial and the initiation of the CardiAMP Heart Failure II Trial. Selling, general, and administrative expenses decreased to $3.3 million from $3.7 million, attributed to lower professional service fees and share-based compensation.
In terms of operational developments, BioCardia is advancing its CardiAMP Cell Therapy System, which has received Breakthrough Device Designation from the FDA for treating ischemic heart failure with reduced ejection fraction (HFrEF) and chronic myocardial ischemia. The company is currently conducting pivotal trials for these indications, with the CardiAMP HF trial presenting data that showed a 47% relative risk reduction in heart death equivalents among patients with elevated NTproBNP biomarkers. The company is also exploring market release approvals in the U.S. and Japan, with expectations of post-marketing studies to gather additional safety and efficacy evidence.
As of December 31, 2025, BioCardia had cash and cash equivalents of approximately $2.5 million, which management believes will not be sufficient to fund operations beyond May 2026 without additional financing. The company has indicated plans to raise capital through various means, including equity or debt financing, but acknowledges the uncertainty surrounding its ability to secure necessary funds. The company’s accumulated deficit has reached approximately $168.3 million, reflecting its ongoing investment in research and development.
BioCardia's workforce consisted of 17 full-time and four part-time employees as of the end of 2025, with no employees covered by collective bargaining agreements. The company has emphasized the importance of attracting and retaining qualified personnel to support its growth and development objectives. Additionally, the company has been proactive in managing its intellectual property, holding over 70 issued or pending patents related to its therapeutic candidates and delivery systems.
Looking ahead, BioCardia's future performance is contingent on the successful completion of its clinical trials and the ability to secure regulatory approvals for its therapeutic candidates. The company faces significant competition in the biotechnology sector, and its ability to generate revenue will depend on market acceptance of its products, if approved. The ongoing development of its CardiAMP Cell Therapy System and allogeneic therapies will require substantial financial resources, and the company remains focused on securing the necessary funding to continue its operations and achieve its strategic goals.
About BioCardia, Inc.
BioCardia, Inc. is a clinical-stage biotechnology company developing autologous and allogeneic cell therapies for cardiovascular and pulmonary diseases, including ischemic heart failure, chronic myocardial ischemia, and acute respiratory distress syndrome. Its core products include the CardiAMP autologous cell therapy system and CardiALLO allogeneic mesenchymal stem cell therapies, delivered via the proprietary Helix biotherapeutic delivery platform. BioCardia targets specialist cardiologists and medical centers, leveraging patented technologies and a direct sales model.
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