His appointment comes as BioVentrix moves into the advanced stages of its Premarket Approval (PMA) submission for the Revivent TCÒ System.
Dr. Ben-Yehuda is a distinguished clinical cardiologist and clinical trialist with more than 25 years’ experience in the treatment of cardiac patients with coronary disease, myocardial infarction, and heart failure. He is currently Professor of Medicine, University of California, San Diego (UCSD). He is also the Editor-in-Chief of Coronary Artery Disease and Deputy Editor of Structural Heart: The Journal of the Heart Team, both peer-reviewed journals.
Previously, Dr. Ben-Yehuda was the Executive Director of the Clinical Trials Center (CTC) at the Cardiovascular Research Foundation (CRF), one of the world’s leading nonprofit organizations specializing in interventional cardiology innovation, research, and education, and Vice President, Cardiovascular Clinical Trials, at Gilead Sciences.
Dr. Ben-Yehuda has personally authored and co-authored over 200 peer-reviewed publications and is the recipient of multiple awards including Top Abstract, TCT Conference 2017, UCSD Department of Medicine Teaching Awards, and Sackler Faculty Prize for Excellence for his MD Thesis.
“We are very pleased to welcome Dr. Ori Ben-Yehuda to BioVentrix as a senior member of our management team,” said Jim Dillon, President and CEO, BioVentrix. “His extensive experience with clinical trial management will make a significant difference as we move forward with the ALIVE Expanded Access Program (ALIVE-EA) and continue to work towards FDA clearance of the Revivent TC System.”
“Despite advances in the care of patients with post myocardial infarction heart failure there remains significant unmet need, particularly in patients with significant scar,” stated Dr. Ben-Yehuda. “The Revivent TC device allows for a minimally invasive therapy, and I am excited at bringing my clinical trial experience to the BioVentrix team as we implement the ALIVE-EA trial and bring the ALIVE pivotal trial to its primary endpoint.”
About the Revivent TC® System
The BioVentrix Revivent TC System is designed to support a minimally invasive procedure to treat a dilated left ventricle of patients with ischemic heart failure with reduced ejection fraction (HFrEF) and extensive left ventricular scar, who have a suboptimal response to guideline-directed medical therapy. The procedure, referred to as Less Invasive Ventricular Enhancement (LIVEÒ) therapy, utilizes myocardial micro-anchor implants to reconstruct the dilated left ventricle to produce a more efficient chamber.
The company announced that it had received approval from the Food and Drug Administration (FDA) for an Expanded Access Program following the successful completion of enrollment in the ALIVE (American Less Invasive Ventricular Enhancement) Trial, a prospective, multi-center, dual-arm pivotal study of the BioVentrix Revivent TC System. Enrollment in the ALIVE Trial was completed in April 2022.
BioVentrix, Inc. is a privately held medical device company focused on the development of less invasive therapies to treat the failing left ventricle (LV), the most common cause of heart failure. BioVentrix technologies aim to improve cardiac function by directly addressing LV dilation. The Company markets the Revivent TC System in Europe and is preparing to submit the Premarket Approval (PMA) application to the FDA for the system later this year.
The BioVentrix, LIVE and Revivent TC trademarks are federally registered trademarks owned by BioVentrix. Any unauthorized use is expressly prohibited.
Investigational Device. Limited to Investigational Use Only in The United States.
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