BioCardia, Inc. (NASDAQ:BCDA), a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today provided an update on near term milestones.

  • BioCardia is working towards a Shonin pre-market regulatory submission to Japan’s Pharmaceutical and Medical Device Agency (PMDA) in Q4 2026. The Company has recently provided detailed responses to PMDA consultation questions and is working with experienced partners on the Shonin Application, the Quality Management System Application, and Foreign Manufacturer Registration. PMDA support for the submission and a successful submission review could result in market clearance by Q4 2027.
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  • BioCardia intends to submit the follow-on De Novo pre-submission for the Helix Transendocardial Delivery Catheter System incorporating the FDA Center for Devices and Radiological Health (CDRH) this quarter. The FDA targets providing an initial acceptance/refusal review within 15 calendar days, and aims to issue written feedback or hold a meeting within 70 calendar days.