Tel Aviv, Israel â 18 November 2024 â SoniVie Ltd., a medical device company pioneering a renal denervation system for hypertension treatment, has announced the appointment of Raymond W. Cohen as Chairman of its Board of Directors. This appointment marks a significant step for the company as it progresses towards US FDA approval and commercialisation of its innovative technology.
Cohen brings a wealth of experience to SoniVie, garnered over four decades in the life sciences industry. He most recently served as CEO and board member of Axonics, Inc., a global medical technology company he co-founded in 2013 and successfully took public in October 2018. Axonics achieved remarkable growth, ranking No. 1 on the 2021 Deloitte Technology Fast 500⢠and the 2022 Financial Times ranking of fastest-growing companies in the Americas. His tenure at Axonics culminated with the company's $3.7 billion acquisition by Boston Scientific Corporation.
Prior to Axonics, Cohen led Vessix Vascular, Inc., a privately held company developing a catheter-based renal denervation system, which was also acquired by Boston Scientific in late 2012. This experience provides Cohen with invaluable insight into the specific market SoniVie is entering and the regulatory pathways involved. His extensive knowledge of renal denervation technology will be instrumental in guiding SoniVie's strategic direction.
Tomaso Zambelli, CEO of SoniVie, expressed his enthusiasm about Cohen's appointment, stating, "We look forward to leveraging Mr. Cohen's extensive experience in growing Medtech companies, particularly his expertise in renal denervation. This is crucial as we navigate our PMA study for US FDA approval and prepare for product commercialisation."
Cohenâs career achievements extend beyond his leadership roles. He is an accredited public company director and currently serves as an independent director of Kestra Medical Technologies, Inc., a commercial-stage company specialising in wearable defibrillators. His contributions to the medical technology sector have been widely recognised, with accolades including the 2024 MedTech MVP Award, the Orange County Business Journal's Businessperson of the Year award, and a SoCal Bio lifetime achievement award. In 2020, he was also named Entrepreneur of the Year by Ernst & Young for the Pacific Southwest United States.
SoniVie's flagship product, the TIVUS⢠(Therapeutic Intra-Vascular Ultrasound System), utilises high-frequency, non-focused ultrasound energy to ablate nerves in the renal artery. This innovative approach aims to reduce blood pressure in patients with hypertension, a condition affecting millions globally and significantly increasing the risk of heart attack, stroke, and kidney failure. The company's pivotal PMA study, "THRIVE," commenced in July 2024 and is currently enrolling patients across the US, Europe, and Israel. This international, multi-centre, randomised, double-blind, sham-controlled study will evaluate the safety and efficacy of the TIVUS⢠System in hypertensive patients who have been off anti-hypertensive medication for a month prior to, and for two months following, the procedure. Data unblinding is scheduled for six months post-procedure. SoniVie operates across Israel, the US and Europe.
Cohen's appointment reinforces SoniVie's commitment to delivering its innovative hypertension treatment to patients worldwide. His leadership and expertise will be vital in navigating the complex regulatory landscape and driving the company's commercial success.