BioCardia Confirms Timing and Provides Update on FDA Helix Pre-Submission and PMDA CardiAMP HF Shonin Submission (Form 8-K)

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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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The confirmatory CardiAMP HF II clinical study is actively enrolling in the United States at four engaged world class centers. The Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration (FDA) has indicated this study may support a Pre Marketing Application.

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BioCardia intends to submit the follow-on De Novo pre-submission for the Helix Transendocardial Delivery Catheter System incorporating the advice from 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.

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An independent FDA clearance of Helix has the potential to expand BioCardia's opportunities to partner with developers of investigational cell, gene and protein therapeutics requiring targeted delivery to the heart.