Cagent Vascular announced the first-in-human cases with its Serranator Sonic IVL system alongside significant funding.
In addition to the first human use of the intravascular lithotripsy (IVL) system, the company closed a $41 million Series D round.
Serranator Sonic IVL’s first human procedures took place in Uzbekistan as part of its REMODEL I study. The study evaluates the IVL system in femoropopliteal and infrapopliteal arteries. Initial cases demonstrated successful calcium modification and lesion remodeling observed through angiographic and IVUS imaging.
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Meanwhile, U.S. Venture Partners (USVP) and Astoria Health Investors provided funding for the $41 million funding round. The company plans to use proceeds to fund a global pivotal trial and the eventual commercial launch of Sonic IVL. It also plans to use funds to support future applications of the IVL platform in coronary arteries.
“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.”
Wayne, Pennsylvania-based Cagent’s Serranator Sonic IVL system brings together its Serranator serration remodeling therapy (SRT) and the Sonic lithotripsy generator. Combined, the system transmits ultrasonic acoustic waves through the balloon and serrated metal elements directly into calcified plaque.
This process force-multiplies the therapeutic effect on the arterial wall to improve vessel compliance at low inflation pressures. Cagent describes its IVL system as the first of its kind using ultrasonic waves and serrated metal elements in this fashion. It marks the latest potential entrant into the growing IVL space led by Johnson & Johnson, with a long list of companies (Boston Scientific, Stryker, Abbott, FastWave Medical, Elixir Medical and Vantis Vascular) looking to follow suit.
Cagent says it designed its system, including the generator, to be fully disposable, with no capital equipment required. It also gives physicians the ability to tailor energy delivery in real-time.
The company believes that its SRT modality addresses a broad range of complex lesion morphologies, including heavily calcified disease. This, Cagent says, positions Sonic to address “a substantially larger share” of the peripheral and coronary arterial markets targeted by IVL.
“For years, physicians treating PAD have had to choose between two highly effective but separate technologies — SRT and IVL,” said Brian Walsh, CEO. “The Sonic IVL system eliminates that tradeoff. For the first time, physicians can access both mechanisms in a single device, in a single procedure.”
