BioCardia provided a regulatory update outlining near-term milestones for its CardiAMP and Helix programs.
BioCardia is working toward a Shonin pre-market submission to Japan’s Pharmaceutical and Medical Device Agency in Q4 2026 and has supplied detailed responses to PMDA consultation questions while preparing the Shonin application, the Quality Management System application and foreign manufacturer registration; PMDA support and a successful review could lead to market clearance by Q4 2027.
The confirmatory CardiAMP HF II study is actively enrolling at four U.S. centers and the FDA Center for Biologics Evaluation and Research has indicated the study may support a Pre-Marketing Application.
BioCardia intends to submit a follow-on De Novo pre-submission for the Helix Transendocardial Delivery Catheter System to the FDA Center for Devices and Radiological Health this quarter, and the FDA targets an initial acceptance or refusal review within 15 calendar days and aims to issue written feedback or hold a meeting within 70 calendar days.
The company states that an independent FDA clearance of Helix could expand opportunities to partner with developers of cell, gene and protein therapeutics requiring targeted delivery to the heart.
