BioCardia targets Q4 2026 Shonin submission for CardiAMP; FDA supports PMA path

BioCardia, Inc.

Targets Q4 2026 Shonin pre-market submission to Japan's PMDA for CardiAMP cell therapy for ischemic heart failure.
FDA meeting minutes confirm ongoing CardiAMP HF II pivotal trial may support Premarket Approval (PMA) in the U.S.
Plans to submit follow-on De Novo pre-submission for Helix transendocardial delivery catheter in Q3 2026.
Advancing Heart3D Fusion Imaging with partner CART-Tech toward potential FDA 510(k) submission.
CEO Peter Altman to present at H.C. Wainwright 28th Annual Global Investment Conference, Sept 14-16, 2026.

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