Cagent Vascular Reports First Human Use of Serranator® SONIC IVL System and Closes Oversubscribed $41M Series D Financing

Financing supports clinical advancement and commercialization of the company’s dual-modality IVL platform, with proceeds funding peripheral commercial launch and coronary program development

WAYNE, Pa.--Cagent Vascular, Inc., a leader in endovascular technologies, today announced two milestones: the successful completion of first human-use cases with the Serranator® SONIC Intravascular Lithotripsy (IVL) System and the closing of a $41 million Series D financing round.

The Serranator® SONIC IVL System brings together Cagent Vascular’s Serranator® Serration Remodeling Therapy (SRT) platform with the SONIC lithotripsy generator—creating a system whose combined effect exceeds what either technology delivers on its own. It is the first IVL system to transmit ultrasonic acoustic waves through the balloon and its serrated metal elements directly into calcified plaque, force-multiplying the therapeutic effect on the arterial wall and improving vessel compliance at low inflation pressures. The system, including the generator, is fully disposable, requires no capital equipment, and gives physicians the ability to tailor energy delivery in real time. Because SRT addresses a broad range of complex lesion morphologies, including heavily calcified disease, which is often accompanied by resistant fibrous plaque, the SONIC IVL System is positioned to address a substantially larger share of the estimated $17 billion peripheral and coronary arterial markets compared to conventional IVL platforms.

The first Serranator SONIC IVL human-use procedures were performed in Uzbekistan, by Drs. S. Iskhakov, N. Madrakhimov, and Steven Kum (Singapore), as part of Cagent Vascular’s REMODEL I Study—a prospective, multicenter study, including centers in New Zealand and Australia, evaluating safety and performance in femoropopliteal and infrapopliteal arteries. First cases demonstrated successful calcium modification and lesion remodeling observed through angiographic and IVUS imaging. Dr. Kum noted, “Even though the initial cases involved complex calcified chronic total occlusions, we were encouraged by the safety, deliverability, and effectiveness of the platform. We observed substantial lumen gain, improved vessel compliance, and appreciated the flexibility of the system’s adjustable energy delivery. From my perspective, this technology has the potential to become an important new tool for treating some of the most challenging cases we typically encounter. Dr. Peter Schneider, Chief Medical Advisor and Co-Founder of Cagent Vascular added, “What makes the SONIC IVL System compelling is that it is genuinely more than the sum of its parts. Combining SRT with lithotripsy ultrasonic energy creates a synergistic effect we do not see with any other technology.”

The $41 million Series D, co-led by U.S. Venture Partners (USVP) and Astoria Health Investors, funds the global REMODEL II pivotal trial and commercial launch of the SONIC IVL System. The round builds on a commercial foundation already established; Cagent Vascular’s Serranator® portfolio is sold nationally across most major U.S. markets, and select major international markets. Proceeds will also fund the Company’s SONIC IVL coronary artery platform.

“For years, physicians treating PAD have had to choose between two highly effective but separate technologies—SRT and IVL,” said Brian Walsh, Chief Executive Officer. “The SONIC IVL System eliminates that tradeoff. For the first time, physicians can access both mechanisms in a single device, in a single procedure.”

“Cagent has developed a next generation IVL platform with significant clinical and commercial potential, building on over 40,000 safe and effective Serranator procedures,” said Casey Tansey of USVP. “This successful first human-use experience, rapidly growing commercial business, and future coronary expansion together positions the company to execute in this high-growth segment.”