BioCardia files revised De Novo pre-submission for Helix catheter

BioCardia, Inc. (Nasdaq: BCDA) has completed the filing of its revised Pre-Submission to the FDA Center for Devices and Radiological Health (CDRH) for the Helix catheter, a device designed for the therapeutic and diagnostic delivery of agents to the heart. The submission is part of the company's Q-Submission program and incorporates specific advice provided by the FDA during a review meeting held in May 2026.

During that May meeting, BioCardia and the FDA reviewed the initial De Novo pre-submission. The agency identified two potential pathways for marketing clearance and raised no concerns regarding the safety data, device performance, or compatibility of the Helix catheter with general classes of agents. In August 2026, the FDA validated the minutes as outlined by BioCardia. The company states that the revised pre-submission reflects the advice detailed in those minutes.

The regulatory filing is supported by clinical data from 15 trials involving nearly 500 patients. BioCardia notes that if the FDA clears the Helix catheter as the first device of its kind, this extensive clinical experience could provide a basis for requiring follow-on catheters to demonstrate non-inferiority to the Helix safety profile before they receive marketing clearance. An independent clearance would also potentially expand BioCardia's opportunities to partner with developers of investigational cell, gene, and protein therapeutics that require targeted delivery to the heart.

The FDA targets providing an initial acceptance or refusal review within 15 calendar days of submission. The agency aims to issue written feedback or hold a meeting within 70 calendar days. BioCardia, headquartered in Sunnyvale, California, develops cellular and cell-derived therapeutics for cardiovascular and pulmonary diseases. Its platforms include CardiAMP autologous and CardiALLO allogeneic cell therapies, which are enabled by the Helix biotherapeutic delivery and Morph vascular navigation systems. The company also has three cardiac clinical-stage product candidates in development and is preparing to launch its Heart3D fusion imaging platform.

The press release includes forward-looking statements regarding the timing and potential outcome of regulatory submissions. These statements are subject to risks and uncertainties, including the company's liquidity position, its ability to raise additional funds, and its success in progressing clinical trials and regulatory programs. BioCardia disclaims any obligation to update these statements except as required by law.