BioCardia updates FDA Helix pre-submission and PMDA CardiAMP HF Shonin timing

BioCardia, Inc.

PMDA Shonin pre-market submission targeted for Q4 2026; possible market clearance by Q4 2027.
FDA Helix follow-on De Novo pre-submission intended this quarter; FDA feedback within 70 calendar days.
CardiAMP HF II trial actively enrolling at four U.S. centers; CBER indicates study may support a PMA.
Company provided detailed responses to PMDA consultation questions; working on QMS and Foreign Manufacturer Registration.

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