In April, BioCardia held a Formal Clinical Consultation with PMDA attended by six cardiologists, during which regulators agreed the U.S. clinical safety and efficacy evidence for CardiAMP autologous cell therapy in ischemic heart failure supports market clearance. The company received a preliminary Advisory Record in May and is preparing responses to advance its Shonin pre-market approval submission, targeting treatment for 20,000 patients annually.

In May, BioCardia’s Q-Sub meeting with the FDA Center for Biologics Evaluation and Research confirmed that Premarket Approval remains the appropriate pathway for CardiAMP HF, with no safety concerns noted. The FDA endorsed continuation of the confirmatory CardiAMP HF II trial across four active U.S. sites: University of Wisconsin, Morton Plant Mease Hospital, Emory University and Henry Ford Health.

BioCardia submitted a Pre-Submission for its Helix Transendocardial Delivery Catheter under the FDA Q-Submission program in February and received feedback in May indicating two viable clearance pathways, including simultaneous approval with CardiAMP or a De Novo route. Regulators raised no safety or performance concerns and advised on a follow-up Pre-Submission to streamline the Helix approval process.

The company maintains a portfolio of over 60 patents and applications worldwide. In March, a Japanese patent titled 'Target Site Selection, Entry, and Update with Automatic Remote Image Annotation' was allowed, extending protection for BioCardia’s Heart3D Fusion Imaging software used in procedural planning and navigation during cell therapy delivery.