BioCardia Inc (BCDA) News & EventsBCDABioCardia Inc

BioCardia's Helix Catheter Pre-Submission Package Accepted by FDA

BioCardia announced the FDA has accepted its pre-submission package for marketing clearance of its Helix catheter intended for therapeutic and diagnostic agent delivery. In May, the company and FDA met and reviewed our initial De Novo pre-submission package. FDA agreed that there are two pathways for Helix marketing clearance and raised no concerns regarding the product's safety data, performance, or compatibility with general classes of agents. In August, FDA confirmed and accepted the meeting minutes. In September, the De Novo pre-submission was revised, incorporating the advice from FDA CDRH as detailed in the meeting minutes, re-submitted and has now been accepted by FDA. BioCardia expects FDA substantive review with written feedback, followed by a meeting with BioCardia to discuss approval via the De Novo pathway, this quarter. The extensive clinical data and safety profile from fifteen clinical trials including nearly five hundred patients presents an opportunity for FDA to ensure that follow-on catheters demonstrate a similar level of safety and clinical experience to obtain clearance. Marketing clearance of Helix by FDA has the potential to expand BioCardia's opportunities to partner with developers of investigational cells, genes, and protein therapeutics requiring targeted delivery to the heart.

BioCardia Completes FDA Pre-Submission for Helix Catheter

BioCardia reported it has completed its revised Pre-Submission to FDA Center for Devices and Radiological Health, CDRH, under its Q-Submission program for the approval of its Helix Catheter for therapeutic and diagnostic agent delivery to the heart.

BioCardia Updates Near Term Milestones, Plans Shonin Submission in 2026

BioCardia provided an update on near term milestones. BioCardia is working towards a Shonin pre-market regulatory submission to Japan's Pharmaceutical and Medical Device Agency in Q4 2026. The Company has recently provided detailed responses to PMDA consultation questions and is working with experienced partners on the Shonin Application, the Quality Management System Application, and Foreign Manufacturer Registration. PMDA support for the submission and a successful submission review could result in market clearance by Q4 2027. The confirmatory CardiAMP HF II clinical study is actively enrolling in the United States at four engaged world class centers. The Center for Biologics Evaluation and Research at the Food and Drug Administration has indicated this study may support a Pre Marketing Application. BioCardia intends to submit the follow-on De Novo pre-submission for the Helix Transendocardial Delivery Catheter System incorporating the FDA Center for Devices and Radiological Health this quarter. The FDA targets providing an initial acceptance/refusal review within 15 calendar days, and aims to issue written feedback or hold a meeting within 70 calendar days