Full Launch of CVAC System Announced, Following Successful Early User Evaluation with Physicians Reporting 99% Median Stone Clearance

PLEASANTON, CA—(BusinessWire)—Calyxo, Inc., a medical device company developing innovative solutions for patients with kidney stones, has announced that positive study results for its CVAC System were presented last week at the American Urological Association (AUA) Annual Meeting in San Antonio.

The CVAC System, a revolutionary technology that is designed for complete kidney stone removal, was the focus of the prospective, randomized, multi-center ASPIRE study, which compared the safety and efficacy of steerable ureteroscopic renal evacuation (SURE) vs ureteroscopy (URS) with basketing. The 30-day results of the ASPIRE study were presented at the AUA Meeting by urologist Thomas Chi, MD of the University of California, San Francisco.

In 101 patients, SURE demonstrated statistically superior stone clearance and significantly lower residual stone volume compared to standard URS. Unlike standard URS, the CVAC System achieved these results independent of baseline stone burden. Safety was comparable between groups. During his presentation, Dr. Chi also shared late-breaking analysis of one-year data that showed a dramatically lower number of emergency department visits, hospitalization and/or retreatment events for SURE patients compared to URS patients.

“Based on our study results, the SURE procedure was determined to be a safe kidney stone treatment that delivers consistently higher stone clearance and lower residual stone volume when compared with URS,” reported Dr. Chi. “This efficacy and safety data, coupled with patient outcomes through the first year of follow up indicates significant promise for SURE procedure using the CVAC System as a potential new gold standard of treatment.”

Calyxo recently introduced a redesigned CVAC System, which is an all-in-one, complete stone clearance device integrating ureteroscopy, laser lithotripsy, irrigation and aspiration. In the early user evaluation, 47 urologists performed 152 cases with the CVAC System and reported an impressive 99% median stone clearance, assessed visually at the end of the procedure. Further, the performance of the CVAC System was judged to be “better than a ureteroscope” in 98% of cases. Finally, in the 70 patients who were expected to require more than one ureteroscopic procedure, physicians believed that CVAC helped avoid the second procedure 77% of the time. These results were collected through physician surveys following the procedure and clinical studies are planned to confirm these findings.

“The AUA meeting was a landmark event for Calyxo and for patients suffering from kidney stones,” said Joe Catanese, PhD, Calyxo’s President & CEO. “Urologist feedback on the new CVAC System and the associated clinical evidence was overwhelmingly positive. We look forward to making the technology more widely available to help more patients in the coming months.”

Approximately 10% of people in the U.S. will have a kidney stone at some point in their lives, according to the AUA. Kidney stone disease is a painful condition that brings with it significant healthcare costs (Current Urology Reports estimates $4.1 billion in annual direct treatment costs by 2030).

“CVAC” and “Calyxo” are registered trademarks of Calyxo, Inc.

About Calyxo, Inc.

Calyxo, Inc. is an innovation-driven medical device company focused on improving care for patients with kidney stones by delivering paradigm-shifting solutions that enable urologists to safely, effectively and efficiently achieve unrivaled clinical outcomes. Learn more at calyxoinc.com.