BioCardia files FDA meeting request for CardiAMP HF accelerated approval; subgroup shows risk reduction

BioCardia, Inc.

Submitted CardiAMP HF clinical study data to FDA; meeting expected Q2 2026 under Breakthrough Designation.
Subgroup with elevated biomarkers showed 47% relative risk reduction in all-cause cardiac death.
Same subgroup had 37% relative risk reduction in non-fatal major adverse cardiac events (stroke, MI, hospitalization).
Quality of life improvements were statistically significant (p=0.04) in the elevated-biomarker subgroup.
Seeking accelerated approval for CardiAMP System in ischemic HFrEF.

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