FDA agrees on two clearance pathways for BioCardia's Helix delivery catheter, favoring simultaneous CardiAMP therapy approval.

BioCardia announced that the FDA agreed on two possible marketing clearance pathways for its Helix Transendocardial Delivery Catheter System, with no safety or performance concerns raised. The FDA's preferred approval route is simultaneous with the CardiAMP cell therapy system for heart failure, but a follow-up pre-submission could allow Helix approval via the DeNovo pathway. This alignment supports BioCardia's goal to independently clear Helix to enhance development and partnerships for other cell, gene, and protein therapies. Upcoming milestones include FDA meetings and clinical presentations in May 2026.