Cagent Vascular recently announced two milestones: the successful completion of first human-use cases with the Serranator Sonic intravascular lithotripsy (IVL) system and the closing of a US$41 million Series D financing round.
The Serranator Sonic IVL system brings together Cagent Vascular’s Serranator serration remodelling therapy (SRT) platform with the Sonic lithotripsy generator. According to a company press release, this 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. Cagent Vascular notes that, because SRT addresses a broad range of complex lesion morphologies, including heavily calcified disease, the Sonic IVL system is positioned to address a substantially larger share of the estimated US$17 billion peripheral and coronary arterial markets compared to conventional IVL platforms.
The first Serranator Sonic IVL human-use procedures were performed in Uzbekistan as part of Cagent Vascular’s REMODEL I study—a prospective, multicentre study including centres in New Zealand and Australia designed to evaluate safety and performance in femoropopliteal and infrapopliteal arteries. First cases demonstrated successful calcium modification and lesion remodelling observed through angiographic and intravascular ultrasound (IVUS) imaging.
Steven Kum (Changi General Hospital, Singapore, Singapore), who performed the first human-use procedures alongside Sherzod Iskhakov (Nano Medical Clinic, Tashkent, Uzbekistan) and Nodir Madrakhimov (Herzchirurgie Würzburg, Würzburg, Germany), 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.”
The US$41 million Series D, co-led by US 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 US markets, and select major international markets. Proceeds will also fund the sompany’s Sonic IVL coronary artery platform.
