— 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.
— Two CVAC System studies awarded Best Abstract Presentation honors in their respective EAU 2026 sessions
PLEASANTON, Calif.--(BUSINESS WIRE)--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 clearance1-5, greater procedural efficiency3, and significant reductions in long-term clinical and economic burden1-2.
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 (URS).2 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.
“The new data build on the robust body of evidence supporting the CVAC System and demonstrate performance across clinical, procedural, and, for the first time, economic outcomes,” 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 results from two related abstracts. The first, Residual Stone Volume, Rather Than Stone‑Free Status, Predicts Downstream Healthcare Utilization After Ureteroscopy: Secondary Analysis of the ASPIRE Trial, awarded Best Abstract Presentation of its session, demonstrated that RSV is a significant and consistent predictor of downstream HCEs1.
The second, a late‑breaking abstract titled Health‑Economic Implications of the SURE Procedure in Kidney Stone Removal: A Claims Data Analysis Based on Two‑Year Results of the ASPIRE Study, expanded on these findings by evaluating the economic impact of the CVAC System using a model‑based cost‑consequence analysis comparing the CVAC System to standard ureteroscopy (URS)2. This analysis incorporated stone events and clinical outcomes data from ASPIRE 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 HCEs with the CVAC System, which resulted in stone‑related follow‑up cost savings of $3,464 per patient ($1,958 for the CVAC System vs. $5,422 for URS).
“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 outcomes. These new health economic data show that consistently achieving low RSV can reduce downstream healthcare utilization and lower the cost of follow-up 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 Hospital presented Simulated Kidney Study of CVAC 2.0 vs. FANS: Fragment Clearance and Surgeon Workload, which also received the Best Abstract Presentation award in its session.3 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 partial withdrawal and reinsertion. 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 RSV reported in several additional abstracts presented at EAU 20264-5. This includes Reproducible Stone Evacuation with CVAC Technology: Pooled Analyses of the ASPIRE and CLEARANCE Trials,4 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,5 presented by Andrew Amenyogbe, 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.
*Emergency room visits, hospitalizations, and retreatments, limited to retreatments likely due to residual stones at the end of the procedure
“CVAC” and “Calyxo” are registered trademarks of Calyxo, Inc.
References
1 Johnson B. Residual Stone Volume, Rather Than Stone-Free Status, Predicts Downstream Healthcare Utilization After Ureteroscopy: Secondary Analysis of the ASPIRE Trial. EAU 2026 Conference Presentation, March 2026. Head-to-Head Randomized Controlled Trial Comparing CVAC System Outcomes vs. Standard URS.
2 Matlaga B, Johnson 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. EAU 2026 Conference Presentation, March 2026. Head-to-Head Randomized Controlled Trial Comparing CVAC System Outcomes vs. Standard URS.
3 Winoker JS, Lee H, Jaekel D. Simulated Kidney Study of CVAC 2.0 vs. FANS: Fragment Clearance and Surgeon Workload. EAU 2026 Conference Presentation, March 2026. Preclinical study comparing CVAC System aspiration efficacy and efficiency vs. flexible and navigable sheaths.
4 Pathak N. Reproducible Stone Evacuation with CVAC Technology: Pooled Analyses of the ASPIRE and CLEARANCE Trials. EAU 2026 Conference Presentation, March 2026. Pooled analysis of results from a prospective single-centre trial using the second-generation CVAC System and the ASPIRE RCT.
5 Cabo J, Amenyogbe A. Multicenter Comparison of Stone Clearance with CVAC Aspiration Ureteroscope and Flexible and Navigable Ureteral Access Sheaths. EAU 2026 Conference Presentation, March 2026. Prospective, multicenter real-world study comparing efficacy of the second-generation CVAC System and a flexible and navigable sheath.
Contacts
Media Contact:
Alyssa Paldo
Alyssa.paldo@finnpartners.com
M: +1 847 791 8085
