Cagent Vascular announced the successful completion of first human-use cases with the Serranator SONIC Intravascular Lithotripsy (IVL) System and the closing of an oversubscribed $41 million Series D financing round.
The financing will support the clinical advancement and commercialization of the company’s dual-modality IVL platform, including the peripheral commercial launch of the SONIC IVL System and development of its coronary artery platform.
The Serranator SONIC IVL System combines the company’s Serranator Serration Remodeling Therapy (SRT) platform with a lithotripsy generator designed to deliver ultrasonic acoustic waves through the balloon and serrated metal elements directly into calcified plaque. According to the company, the combined technology is designed to improve vessel compliance at low inflation pressures while addressing complex lesion morphologies, including heavily calcified disease accompanied by resistant fibrous plaque.
The system is fully disposable, does not require capital equipment, and allows physicians to tailor energy delivery during procedures. Cagent Vascular said the platform is targeting a larger share of the estimated $17 billion peripheral and coronary arterial markets compared to conventional IVL technologies.
The first human-use procedures were performed in Uzbekistan by Drs. S. Iskhakov, N. Madrakhimov, and Steven Kum as part of the REMODEL I Study, a prospective multicenter study evaluating the system’s safety and performance in femoropopliteal and infrapopliteal arteries. The study also includes centers in New Zealand and Australia.
According to the company, the initial procedures demonstrated successful calcium modification and lesion remodeling observed through angiographic and IVUS imaging.
The $41 million Series D financing was co-led by U.S. Venture Partners (USVP) and Astoria Health Investors. The proceeds will fund the global REMODEL II pivotal trial and support the commercial rollout of the SONIC IVL System. The company noted that its Serranator portfolio is already sold nationally across most major U.S. markets and in select international markets.
KEY QUOTES:
“For years, physicians treating PAD have had to choose between two highly effective but separate technologies, SRT and IVL. The SONIC IVL System eliminates that tradeoff. For the first time, physicians can access both mechanisms in a single device, in a single procedure.”
Brian Walsh, Chief Executive Officer, Cagent Vascular
“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. Steven Kum
“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.”
Dr. Peter Schneider, Chief Medical Advisor And Co-Founder, Cagent Vascular
“Cagent has developed a next generation IVL platform with significant clinical and commercial potential, building on over 40,000 safe and effective Serranator procedures. 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.”
Casey Tansey, USVP
