The CardiAMP Cell Therapy System is BioCardia's lead product, designed for treating heart failure and chronic myocardial ischemia. Research and development activities focus on Phase 3 clinical trials to evaluate the safety and efficacy of autologous cell therapy. The technology utilizes a patient's own bone marrow-derived cells, which are processed and delivered to the heart using the Helix biotherapeutic delivery system. This approach aims to regenerate damaged heart tissue and improve cardiac function. Patient impact includes potential improvements in heart function, reduced hospitalizations, and enhanced quality of life for those suffering from heart failure. BioCardia's market positioning is as a pioneer in regenerative medicine for cardiovascular diseases, with a focus on addressing unmet medical needs. Future opportunities include expanding the application of CardiAMP to other cardiac conditions and securing regulatory approvals globally. Clinical trials are a key aspect of this segment, with ongoing efforts to gain FDA approval and expand into international markets. Partnerships with research institutions and hospitals are crucial for conducting clinical trials and advancing the technology.

The Helix system is a percutaneous catheter delivery system designed for cardiovascular regenerative medicine. Research and development efforts are focused on refining the catheter's design and improving its delivery capabilities for various cell therapies. The technology involves a steerable catheter that allows for precise and targeted delivery of therapeutic cells to the heart. This system is used in conjunction with the CardiAMP Cell Therapy System and other regenerative medicine approaches. The primary therapeutic area is cardiovascular disease, specifically heart failure and chronic myocardial ischemia. Patient impact includes improved precision in cell delivery, potentially leading to better therapeutic outcomes. BioCardia's market positioning is as a provider of innovative delivery systems that enhance the effectiveness of cell therapies. Future opportunities include expanding the use of the Helix system to deliver other types of therapeutics and to treat a wider range of cardiovascular conditions. Regulatory aspects involve obtaining FDA approval for the device and ensuring compliance with medical device regulations. Partnerships with cell therapy developers and research institutions are essential for integrating the Helix system with new therapeutic approaches.

The Morph product family includes steerable introducer product family. Research and development activities focus on improving the design and functionality of the Morph devices to enhance their performance in various cardiovascular procedures. The technology involves steerable introducers and sheaths that provide precise access and navigation within the cardiovascular system. These devices are used in conjunction with other therapeutic interventions, including cell therapies and catheter-based procedures. The primary therapeutic area is cardiovascular disease, with applications in procedures such as cell delivery and diagnostic interventions. Patient impact includes improved precision and safety during cardiovascular procedures, potentially leading to better outcomes. BioCardia's market positioning is as a provider of innovative access devices that support a range of cardiovascular interventions. Future opportunities include expanding the Morph product line to include new features and applications, as well as securing regulatory approvals for new indications. Regulatory aspects involve obtaining FDA approval for the devices and ensuring compliance with medical device regulations. Partnerships with interventional cardiologists and device manufacturers are important for product development and market access.