BioCardia, Inc. Submits CardiAMP HF Clinical Data To U.S. Food And Drug Administration To Pursue Potential Accelerated Approval Pathway

BioCardia, Inc. announced that it has submitted clinical data from its CardiAMP HF study to the U.S. Food and Drug Administration (FDA) and is preparing to meet with regulators to discuss a potential accelerated approval pathway for its CardiAMP System, an investigational therapy for patients with ischemic chronic heart failure with reduced ejection fraction (HFrEF).

According to the company, the meeting request follows previously outlined plans, with the discussion expected to take place this quarter. The consultation will occur under the FDA Breakthrough Device Designation already granted to the CardiAMP System, a status intended to streamline development and review of promising technologies for serious medical conditions.

BioCardia said it will seek FDA feedback on whether its proposed approval pathway is supported by the CardiAMP HF Trial findings, which include safety outcomes, clinical response data from 125 enrolled ischemic HFrEF patients, and a positive benefit-risk assessment in a subgroup of participants showing elevated biomarkers of heart stress.

For this higher-risk subgroup, the CardiAMP cell therapy has demonstrated additional clinical benefits when used alongside standard American Heart Association and American College of Cardiology guideline-directed medical therapy. Over a two-year period, patients in this category experienced a 47% relative reduction in all-cause cardiac death, a 37% reduction in non-fatal major adverse cardiac events such as stroke, myocardial infarction and hospitalization, and statistically significant improvements in quality of life.

The company noted that these findings support the potential of the CardiAMP System to address an urgent unmet need for patients whose condition persists despite currently recommended treatments. Updated study results were recently presented at the Technology and Heart Failure Therapeutics (THT) 2026 Annual Meeting and are now available on BioCardia’s website.