— Two-year health economics analysis shows that reducing residual stone burden with the CVAC System lowers follow-up healthcare costs by 64%, saving an average of $3,464 per patient
— New preclinical data demonstrate that the second-generation CVAC System delivers superior aspiration performance compared with suction sheaths.
PLEASANTON, CA — March 17, 2026 — Calyxo, Inc., a medical device company revolutionizing kidney stone treatment, today announced the presentation of six new abstracts at the 41st Annual European Association of Urology Annual Congress in London (EAU26). The data collectively differentiate the CVAC System as a unique, high-performance aspiration system that delivers superior stone clearance1,3,4, greater procedural efficiency2, and significant reductions in long-term clinical and economic burden1,5.
Among the findings is a late-breaking abstract presenting the first health economics analysis derived from long‑term, randomized clinical trial data comparing the Steerable Ureteral Renal Evacuation (SURE) procedure performed with the CVAC System to standard ureteroscopy. The analysis demonstrates that the consistently low residual stone volume (RSV) achieved with the CVAC System is associated with fewer downstream healthcare consumption events (HCEs) and lower follow-up healthcare costs.
“This robust body of new evidence continues to highlight the consistent performance of the CVAC System across clinical and procedural outcomes and, for the first time, economic outcomes as well,” said Jacqueline Welch, M.D., Ph.D., VP Medical and Clinical Affairs at Calyxo. “The breadth and momentum of this evidence underscore our commitment to demonstrating how the CVAC System can improve kidney stone care, supporting more complete and lasting stone clearance while reducing the downstream burden on patients and the healthcare system.”
Brett Johnson, M.D., Associate Professor in the Department of Urology at UT Southwestern Medical Center, presented the new health economic data in a late-breaking abstract Health-Economic Implications of the SURE procedure in Kidney Stone Removal: A Claims Data Analysis based on Two-Year Results of the ASPIRE Study.1 The study evaluated the economic impact of the CVAC System using a model-based cost-consequence analysis comparing the CVAC System to standard ureteroscopy. The analysis incorporated stone events and clinical outcomes data from the ASPIRE study and combined these with claims datasets to estimate healthcare utilization and associated costs at one and two years following treatment.
The analysis found a 64% reduction in healthcare consumption events (HCE) with the CVAC System, which resulted in stone-related follow-up cost savings of $3,464 ($1,958 for the CVAC System vs. $5,422 for URS). The study authors concluded that these savings “provide a basis to partially or fully amortize incremental index treatment cost.”
“For the first time, we have clear evidence of how the clinical value of the CVAC System translates directly into economic value,” said Dr. Johnson. Evidence across multiple studies has demonstrated that the CVAC System results in a significant reduction in RSV, which in turn is proven to improve long-term patient outcomes5. These new health economic data show that consistently achieving low RSV can reduce downstream healthcare utilization and also lower the cost of care, benefitting the healthcare ecosystem as a whole.”
Jared S. Winoker, M.D., Director of Endourology and Director of the Center for Kidney Stone Disease at Lenox Hill presented Simulated Kidney Study of CVAC 2.0 vs. FANS: Fragment Clearance and Surgeon Workload.2 This study compared the aspiration efficacy, efficiency, and procedural burden of the CVAC System and flexible and navigable suction ureteral access sheath (FANS) using a five-calyx silicone kidney model designed to replicate intrarenal volume, anatomy, and compliance during suction.
Results show that the CVAC System achieved complete or near-complete clearance across all fragment sizes. While clearance was similar between the devices in dust-sized fragment conditions (median 230 μm), FANS efficacy declined significantly as fragment size increased, with 74%, 73%, and 49% clearance for 640 μm, 1.65 mm, and 2 mm fragments, respectively (p<0.05 for all sizes).
Residual stone volume (RSV) remained consistently low for the CVAC System but increased for FANS with increasing fragment sizes (<36 mm3 vs. 152-299 mm3, respectively). Clearing fragments larger than 640 μm with FANS frequently required repeated scope withdrawal and partial reinsertion, whereas the CVAC System enabled single-pass aspiration in all cases. These additional scope maneuvers increased procedural strain with FANS, reflected by higher NASA-TLX Physical and Temporal scores (both p=0.006).
These preclinical results validate the design of the second-generation CVAC System, which integrates irrigation and vacuum aspiration to enable continuous stone clearance during and after laser lithotripsy. The findings also help explain the consistently high stone clearance and low residual stone volume (RSV) reported in several additional abstracts presented at EAU 2026. These include Reproducible Stone Evacuation with CVAC Technology: Pooled Analyses of the ASPIRE and CLEARANCE Trials,3 presented by Niramya Pathak, Consultant Urologist at Muljibhai Patel Hospital, which reported consistent performance independent of baseline stone volume.
Multicenter Comparison of Stone Clearance with CVAC Aspiration Ureteroscope and Flexible and Navigable Ureteral Access Sheaths,4 presented by Jackson Cabo, M.D., an Endourology Fellow at Mayo Clinic Arizona, on behalf of the EDGE Consortium, further supports these findings. This retrospective, multicenter analysis of 493 patients treated with either the CVAC System or FANS found that the CVAC System maintained low residual stone volume (RSV) independent of pre-operative stone volume. In contrast, RSV with FANS increased significantly as pre-operative stone volume increased (p<0.001). Notably, patients treated with the CVAC System in this study had twice the pre-operative stone volume of those undergoing FANS (789 mm3 vs 403 mm3).
Collectively, these studies provide a consistent clinical evidence base that supports the newly reported health economic findings.
About Kidney Stones
According to the American Urological Association, approximately 10% of people in the U.S. will have a kidney stone at some point in their lives. Kidney stone disease is a painful condition that can result in significant healthcare costs (Current Urology Reports estimates $4.1 billion in annual direct treatment costs by 2030).
About the CVAC System
The latest-generation CVAC System was FDA-cleared in 2024 and enables a minimally invasive approach for kidney stone clearance. It is an all-in-one solution designed to efficiently and effectively remove kidney stones. It uses irrigation and vacuum aspiration to continuously clear stone fragments during and after laser lithotripsy, enabling physicians to achieve a stone-free outcome.
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.
“CVAC” and “Calyxo” are registered trademarks of Calyxo, Inc.
Media Contact:
Alyssa Paldo
Alyssa.paldo@finnpartners.com
M: +1 847 791 8085
References
- Matlaga B. Health-Economic Implications of the SURE procedure in Kidney Stone Removal: A Claims Data Analysis based on Two-Year Results of the ASPIRE Study. EAU2026 Conference Presentation, March 2026. Head-to-Head Randomized Controlled Trial Comparing CVAC System Outcomes vs. Standard URS
- Winoker JS, Lee H, Jaekel D. Simulated Kidney Study of CVAC 2.0 vs FANS: Fragment Clearance and Surgeon Workload. EAU2026 Conference Presentation, March 2026. Pre-Clinical Study Comparing CVAC System Aspiration Efficacy and Efficiency vs. Flexible and Navigable Sheaths
- Pathak N. Reproducible Stone Evacuation with CVAC Technology: Pooled Analyses of the ASPIRE and CLEARANCE Trials. EAU2026 Conference Presentation, March 2026. Pooled Analysis of Results from Prospective Single-Centre Trial Using the Second-Generation CVAC System and ASPIRE RCT
- Cabo J. Multicenter Comparison of Stone Clearance with CVAC Aspiration Ureteroscope and Flexible and Navigable Ureteral Access Sheaths. EAU2026 Conference Presentation, March 2026. Prospective, Multi-Center Real-World Study Comparing Efficacy of Second-Generation CVAC System and Flexible and Navigable Sheath.
- Johnson B. Residual Stone Volume, Rather Than Stone-Free Status, Predicts Downstream Healthcare Utilization After Ureteroscopy: Secondary Analysis of the ASPIRE Trial, March 2026. Head-to-Head Randomized Controlled Trial Comparing CVAC System Outcomes vs. Standard URS
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