Cagent’s Serranator Sonic IVL System Used in FIH Procedures

May 19, 2026—Cagent Vascular, Inc. announced the successful completion of the first-in-human-use (FIH) procedures with the Serranator Sonic intravascular lithotripsy (IVL) system.

The company advised that the cases were part of its REMODEL I prospective, multicenter study evaluating the Serranator Sonic IVL system’s safety and performance in femoropopliteal and infrapopliteal arteries. The study includes centers in New Zealand and Australia, noted Cagent Vascular.

Additionally, the company announced it closed a $41 million Series D financing round, which was co-led by U.S. Venture Partners and Astoria Health Investors. The financing round will fund the global REMODEL II pivotal trial and commercial launch of the Serranator Sonic IVL system. The proceeds will also fund Cagent Vascular’s Sonic IVL coronary artery platform.

According to the company, the Serranator Sonic IVL system combines its Serranator serration remodeling therapy (SRT) platform with the Sonic lithotripsy generator. SRT addresses a broad range of complex lesion morphologies, including heavily calcified disease.

Cagent Vascular stated that the device transmits ultrasonic acoustic waves through the balloon and its serrated metal elements directly into calcified plaque, creating a force-multiplying therapeutic effect on the arterial wall and improving vessel compliance at low inflation pressures.

The FIH procedures with the device were performed in Uzbekistan by Sherzod A. Iskhakov, MD; Nodir Madrakhimov, MD; and Steven Kum, MD.

“Even though the initial cases involved complex calcified chronic total occlusions, we were encouraged by the safety, deliverability, and effectiveness of the platform,” commented Dr. Kum in the company’s press release. “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.”