BioCardia provides timing update on FDA Helix pre-submission and PMDA CardiAMP HF Shonin submission
核心洞察
BioCardia is preparing a Shonin pre-market regulatory submission to Japan's PMDA in Q4 2026 for its CardiAMP autologous cell therapy in ischemic heart failure (搜索).
The company has answered detailed PMDA consultation questions and is working with partners on the Shonin Application, Quality Management System Application and Foreign Manufacturer Registration.
PMDA support and a successful review could yield market clearance by Q4 2027, while the confirmatory CardiAMP HF II study enrolls at four US centers.
BioCardia said it is working toward a Shonin pre-market regulatory submission to Japan's Pharmaceutical and Medical Device Agency (PMDA) in the fourth quarter of 2026 for CardiAMP, its autologous cell therapy for ischemic heart failure (搜索). 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 review could result in market clearance by Q4 2027.
The confirmatory CardiAMP HF II clinical study is actively enrolling in the United States at four engaged centers. The FDA's Center for Biologics Evaluation and Research (CBER) has indicated the study may support a Pre Marketing Application.
Separately, BioCardia intends to submit the follow-on De Novo pre-submission for the Helix Transendocardial Delivery Catheter System (搜索) incorporating the FDA Center for Devices and Radiological Health (CDRH) this quarter. 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. An independent FDA clearance of Helix could expand BioCardia's opportunities to partner with developers of investigational cell, gene and protein therapeutics requiring targeted delivery to the heart.