GlobeNewswire·Oct 19, 2026, 9:15 AM ET

BioCardia Announces FDA Acceptance of De Novo Pre-Submission Package for Helix™ Catheter Marketing Clearance FDA Substantive Review and Meeting Expected this Quarter

BioCardia, Inc. announced that the FDA has accepted its revised De Novo pre-submission package for marketing clearance of the Helix catheter.
The FDA agreed in May 2026 that two pathways exist for clearance & raised no safety, performance, or compatibility concerns.
BioCardia expects substantive FDA review with written feedback & a meeting to discuss De Novo approval this quarter.
The submission includes extensive clinical data from fifteen trials involving nearly 500 patients to demonstrate safety & clinical experience.
FDA clearance could enable BioCardia to partner with developers of investigational cells, genes, & protein therapeutics for targeted heart delivery.
The Helix catheter is a minimally invasive platform designed for precise intramyocardial delivery of agents with superior retention.
The device features a specialized distal helical needle that engages heart tissue from within the chamber to ensure stability during delivery.
BioCardia develops cellular therapeutics including CardiAMP® autologous & CardiALLO™ allogeneic cell therapies for cardiovascular & pulmonary diseases.
The press release includes standard forward-looking statements regarding risks such as regulatory approvals, funding needs, & clinical trial progress.