New heart catheter for cell therapy delivery 1 step closer to FDA approval
BioCardia, a California-based regenerative medicine company, is closer than ever to receiving U.S. Food and Drug Administration (FDA) approval for a new catheter capable of delivering cell and gene therapies directly into the heart.
The company has officially completed its pre-submission to the FDA after previously receiving the agency’s breakthrough device designation. Its goal is to work with the FDA and then follow up with an application for market clearance.
The Helix Transendocardial Delivery Catheter was designed to deliver therapies intramyocardially. It is guided by BioCardia’s FDA-approved Morph DNA Steerable Introducer and includes a small distal helical needle that directly engages with the patient’s cardiac tissue. The investigational device can be used by interventional cardiologists, electrophysiologists or cardiac surgeons.
“This pre-submission and discussion with FDA should lead to our Helix catheter being the first approved transendocardial delivery catheter system in the United States,” Peter Altman, PhD, BioCardia’s president and CEO, said in a statement. “FDA clearance of Helix will streamline the future approvals of BioCardia’s autologous and allogeneic cell therapies for the treatment of heart failure and chronic myocardial ischemia. Approval should also reduce development risk for biopharmaceutical and biotechnology partners seeking to employ our best-in-class minimally invasive delivery technology for cardiovascular cell, gene and protein development programs aiming to address enormous unmet medical needs.”
BioCardia pointed to positive data on the Helix technology published in Cardiovascular Revascularization Medicine and International Heart Journal in 2021 and 2017, respectively.[1, 2]
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.