BCDA News & Events

BioCardia completed its Pre-Submission to FDA under its Q-Submission program for the approval of its Helix Transendocardial Delivery Catheter for intramyocardial therapeutic and diagnostic agent delivery. The data supporting safety and effectiveness for the Helix Pre-Submission is from fifteen well-controlled clinical trials of cell and gene therapy delivery to the heart using Helix, where patients were enrolled in three primary cardiac clinical indications. The Helix Pre Submission has been made under the CardiAMP Cell Therapy System FDA Breakthrough Designation, which the Helix underlies. BioCardia seeks to align with FDA on the regulatory pathway and timing for approval in the next 45 days. An application for market clearance could soon follow.

BioCardia announces it has completed a third preliminary clinical consultation with Japan's Pharmaceutical and Medical Device Agency, PMDA, on CardiAMP Cell Therapy intended for treatment of Heart Failure with Reduced Ejection Fraction, HFrEF. The meeting was held in further preparation for formal clinical consultation on acceptability of the existing clinical data for submission of an application for approval. Based on the discussions in the most recent meeting, PMDA said it will allow BioCardia to advance to formal clinical consultation. Should PMDA agree in formal consultation that the available data provides sufficient evidence of safety and efficacy, BioCardia would be able to file for regulatory approval in Japan.

BioCardia (BCDA) announced the election of Marvin Slosman to its Board of Directors, effective December 2, 2025. Dr. Richard Krasno, who has served on the Board since 2016, has completed his term and departed the Board effective December 2, 2025. Slosman currently serves as President, Chief Executive Officer, and Director of InspireMD (NSPR)

BioCardia announces the appointment of Farhan Shahab as Vice President of Quality. Shahab joins BioCardia from Welldoc, where he served as Vice President of Quality and Regulatory