BioCardia, Inc. (Nasdaq: BCDA) filed a Current Report on Form 8-K on September 23, 2026, to announce updates regarding its regulatory submissions in the United States and Japan. The company confirmed specific timelines for a pre-submission regarding its Helix delivery platform and a Shonin application for its CardiAMP therapy in Japan.
Regarding the CardiAMP autologous cell therapy for ischemic heart failure, BioCardia stated it is working towards a Shonin pre-market regulatory submission to Japan’s Pharmaceutical and Medical Device Agency (PMDA) in the fourth quarter of 2026. The company noted that it has recently provided detailed responses to PMDA consultation questions and is collaborating with experienced partners on the Shonin Application, the Quality Management System Application, and Foreign Manufacturer Registration. The company indicated that PMDA support for the submission and a successful review could result in market clearance by the fourth quarter of 2027.
In the United States, BioCardia confirmed that the confirmatory CardiAMP HF II clinical study is actively enrolling at four engaged centers. The FDA’s Center for Biologics Evaluation and Research (CBER) has indicated that this study may support a Pre Marketing Application.
The company also provided an update on its Helix Transendocardial Delivery Catheter System. BioCardia intends to submit a follow-on De Novo pre-submission this quarter, incorporating advice from the FDA Center for Devices and Radiological Health (CDRH). The FDA has targeted providing 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 noted that 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.
