Cagent Vascular has raised $41m and completed the first-in-human use cases of its Serranator SONIC intravascular lithotripsy (IVL) platform.
The Pennsylvania-based company’s Series D financing round was co-led by US Venture Partners (USVP) and Astoria Health Investors. Cagent plans to use the funds towards the completion of a pivotal trial, called REMODEL II, and to support commercial activities surrounding SONIC IVL.
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Serranator SONIC is a dual-modality IVL platform that combines Cagent’s Serranator serration remodelling therapy (SRT) platform with its SONIC lithotripsy generator.
US Food and Drug Administration (FDA)-cleared in 2017, Serranator treats calcified lesions by applying SRT, wherein serrated metal strips attached to a balloon during angioplasty create controlled micro‑incisions in arterial plaque to open the artery at lower pressure and with minimal trauma. Meanwhile, IVL is a catheter-based procedure used to break up hardened calcium deposits in blood vessels by emitting sonic pressure (shock) waves.
Since SRT has the ability to address a broad range of complex lesion morphologies, including heavily calcified disease, SONIC IVL is positioned to address a larger share of the estimated $17bn peripheral and coronary arterial markets compared to conventional IVL platforms, Cagent stated.
Cagent CEO Brian Walsh said: “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 trade-off. For the first time, physicians can access both mechanisms in a single device, in a single procedure.”
SONIC IVL’s first-in-human cases were performed in Uzbekistan as part of Cagent’s REMODEL I (NCT07575568) prospective study. These cases evaluated the platform’s safety and performance in femoropopliteal and infrapopliteal arteries. The company has not yet revealed data from the trial.
Johnson & Johnson (J&J) is viewed as the IVL market leader, a position it has held since acquiring Shockwave Medical in a $13.1bn deal in June 2024, giving J&J access to several IVL products. However, since this deal, the IVL space has attracted the interest of other industry players.
On 19 May, Boston Scientific shared positive pivotal trial results for its SEISMIQ 4CE Coronary intravascular lithotripsy (IVL) catheter in treating calcified coronary artery disease (CAD).
The 420-patient FRACTURE trial (NCT06181240) met its primary safety endpoint with a 93.3% rate of freedom from major adverse cardiac events (MACE), including cardiovascular death and myocardial infarction at 30 days, outpacing the study’s prespecified performance goal of 86.2%.
Boston entered the IVL space via the $664m acquisition of Bolt Medical in January 2025, with Bolt’s peripheral catheter system gaining FDA clearance in March 2025. Boston later rebranded the Bolt technology to Seismiq.
