SUNNYVALE, Calif., June 5, 2026
BioCardia, Inc. announced that it has received official meeting minutes from the U.S. Food and Drug Administration (FDA) following a Q-Sub meeting with the Center for Biologics Evaluation and Research (CBER) regarding its investigational CardiAMP® Cell Therapy System for the treatment of ischemic heart failure with reduced ejection fraction (HFrEF). According to the FDA feedback, the ongoing CardiAMP Heart Failure II (HF II) Trial may support a future Premarket Approval (PMA) application, representing a significant regulatory milestone for the company’s lead cardiovascular cell therapy program. The development strengthens BioCardia’s pathway toward commercialization of a treatment designed to address a major unmet need in heart failure care.
FDA Feedback Strengthens Regulatory Pathway
The FDA’s confirmation that the ongoing CardiAMP HF II trial may support a PMA application marks an important advancement for the program. PMA is the agency’s most rigorous regulatory pathway for high-risk medical devices and requires substantial evidence demonstrating safety and effectiveness before approval for public use. Historically, the FDA has indicated a preference for two well-designed clinical studies when evaluating therapies for large patient populations such as ischemic HFrEF, a condition affecting more than one million patients in the United States. BioCardia noted that the agency recognizes both the unmet medical need in this patient population and the strengths of the clinical data generated from the completed CardiAMP HF study, which may serve as one of the key trials supporting future approval.
CardiAMP Therapy Targets Cardiac Repair
CardiAMP Cell Therapy is an autologous regenerative treatment that utilizes a patient’s own bone marrow-derived cells. The therapy is delivered directly to damaged heart tissue through a minimally invasive catheter-based procedure designed to improve cardiac function by increasing capillary density and reducing tissue fibrosis. The treatment aims to address underlying microvascular dysfunction, a significant contributor to progressive heart failure. The therapy has previously received FDA Breakthrough Device Designation, reflecting its potential to provide more effective treatment options for patients suffering from serious cardiovascular conditions. BioCardia believes the therapy could offer a novel approach for patients with limited treatment alternatives despite advances in standard heart failure management.
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Global Development Efforts Continue
Beyond the United States, BioCardia continues to advance CardiAMP through international regulatory discussions. The company reported that Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has indicated that data from three completed clinical studies may provide sufficient evidence of safety and efficacy to support a future regulatory submission. Clinical development of CardiAMP for heart failure has also received support from the Maryland Stem Cell Research Fund, while trial participation costs are reimbursed by the Centers for Medicare & Medicaid Services (CMS). These developments underscore growing institutional support for the program as it progresses through late-stage clinical evaluation.
Expanding Regenerative Medicine Opportunities
BioCardia is focused on developing cellular and cell-derived therapies targeting cardiovascular and pulmonary diseases. In addition to the CardiAMP platform, the company is advancing CardiALLO™ allogeneic cell therapies and leveraging its proprietary Helix™ biotherapeutic delivery, Morph® vascular navigation, and upcoming Heart3D™ fusion imaging technologies. The positive FDA feedback provides additional momentum for the CardiAMP HF II trial and reinforces the company’s broader strategy of bringing regenerative medicine solutions to patients with severe cardiovascular disease. If successful, CardiAMP could become one of the first cell-based therapies approved for ischemic heart failure, potentially offering a new treatment paradigm for a large and underserved patient population.
Source: BioCardia press release
