BioCardia announced positive FDA Pre-Submission Meeting outcomes for Helix Transendocardial Delivery Catheter System, confirming two clearance pathways with no safety or performance concerns.
Key takeaways
FDA agreed on two marketing clearance pathways for Helix: simultaneous with CardiAMP approval or DeNovo pathway via follow-on pre-submission.
FDA raised no concerns on Helix safety data, device performance, or compatibility with general classes of agents.
FDA prefers simultaneous approval of Helix with CardiAMP cell therapy for heart failure treatment.
Helix enables precise intramyocardial delivery of therapeutics with superior retention and access to hard-to-reach heart regions.
Upcoming catalysts include FDA CBER meeting on CardiAMP approval pathways and CardiAMP readout at EuroPCR.
CEO Altman views pathways as synergistic, enhancing partnering for cell, gene, and protein therapeutics.