Calyxo showcases promising results for its CVAC System device in kidney stone treatment

Calyxo showcases promising results for its kidney stone device: ©natali_mis - stock.adobe.com

Calyxo Inc. unveiled a wide range of clinical, pre-clinical, and real-world evidence supporting the safety and effectiveness of its CVAC System for kidney stone removal during the American Urological Association 2025 Annual Meeting, held April 26–29 in Las Vegas.

The data highlight the growing momentum behind the company’s steerable ureteroscopic renal evacuation (SURE) procedure, which uses the second-generation CVAC System. Results presented at the conference show that the system consistently achieves high stone-clearance rates across diverse patient populations and clinical settings—key factors in reducing repeat procedures.

“The multiple data sets presented at AUA 2025 clearly show that the SURE procedure using the second-generation CVAC System safely and effectively achieves this goal regardless of stone burden,” said Brian Eisner, co-director of the Kidney Stone Program at Massachusetts General Hospital and lead author of one of the featured abstracts. “The combined safety and efficacy address a long-standing unmet need in kidney stone removal and brings us closer to making one-and-done treatment a reality for the vast majority of patients.”

In a large, multi-site, real-world study from Northwell, the CVAC System achieved a 57% stone-free rate—surpassing the 48% seen in the controlled ASPIRE trial. Meanwhile, a retrospective analysis at the University at Buffalo found a median stone clearance rate of 96.4%, and researchers at UC San Diego reported over 99% clearance in most patients.

Beyond effectiveness, safety data from ex-vivo and in-vivo studies suggest that the CVAC System maintains consistently low intrarenal pressure, a critical factor in minimizing complications during ureteroscopy. At Massachusetts General Hospital, researchers found IRP was 1.7 to 2.9 times higher when using conventional ureteroscopes compared to the CVAC System in a non-compliant kidney model.

“Our initial experience with the second-generation CVAC System has been impressive,” said Jared S. Winoker, director of Endourology at Lenox Hill and senior author on another abstract. “The data from our study, along with other real-world evidence presented at AUA 2025, demonstrate that the CVAC System delivers consistent and excellent outcomes across diverse clinical sites and operators.”

A prospective study at the Mayo Clinic further reinforced the CVAC System’s superiority by showing that it removed more stone volume and caused fewer device-related complications than flexible and navigable ureteric access sheaths (FANS), a competing technology.

Joe Catanese, CEO of Calyxo, noted that the results demonstrate the CVAC System’s increasing role in modern urological practice. “The breadth of clinical, pre-clinical, and real-world data presented at AUA 2025 reflects the increasing clinical experience with the CVAC System,” he said. “With over 10,000 patients treated using the SURE procedure, the data reinforces the role of the CVAC System in helping physicians deliver effective stone clearance.”

Kidney stone disease affects approximately 10% of Americans and is projected to drive $4.1 billion in annual treatment costs by 2030, according to the American Urological Association. Calyxo’s CVAC System, FDA-cleared in 2024, aims to streamline kidney stone treatment through its unique combination of irrigation and vacuum aspiration to remove stone fragments efficiently.