BioCardia Files Q2 FDA Meeting Request for Accelerated Approval of CardiAMP in 125-Patient Trial
BioCardia filed for an FDA meeting this quarter under its Breakthrough Designation to discuss accelerated approval of the CardiAMP System based on 125-patient CardiAMP HF trial data. The subgroup with elevated heart stress biomarkers showed 47% lower all-cause cardiac death and 37% fewer non-fatal major adverse cardiac events.
1. FDA Meeting Request
BioCardia has submitted CardiAMP HF trial data to the FDA and requested a meeting this quarter under its Breakthrough Designation to explore an accelerated approval pathway for the CardiAMP System in ischemic chronic heart failure with reduced ejection fraction.
2. CardiAMP HF Trial Data
In the CardiAMP HF study, 125 ischemic HFrEF patients received autologous bone marrow cell injections and showed a favorable safety profile; the subgroup with elevated biomarkers experienced a 47% relative risk reduction in all-cause cardiac death and a 37% reduction in non-fatal major adverse cardiac events, plus improved quality of life (p=0.04).
3. CardiAMP System and Development
The CardiAMP System uses a minimally invasive catheter-based procedure to deliver a patient’s own cells to myocardial tissue, aiming to increase capillary density and reduce fibrosis; clinical development is supported by the Maryland Stem Cell Research Fund and reimbursed by CMS under the FDA’s Breakthrough Designation.