AUA 2026 Data Reinforce Procedural Efficiency, Stone Clearance, and Safety of the CVAC System in the Real World

Multi-center and pre-clinical studies demonstrate high stone clearance and aspiration efficiency of the CVAC System compared to suction sheaths and direct-in-scope suction (DISS)

Large retrospective study of 789 patients confirms real-world CVAC System efficacy and safety are consistent with controlled trial results

PLEASANTON, Calif.--(BUSINESS WIRE)--Calyxo, Inc., a medical device company redefining kidney stone treatment, today highlighted the results from multiple studies presented at the American Urological Association (AUA) 2026 Annual Meeting evaluating the performance of the CVAC System across comparative analyses, benchtop testing, and real-world safety outcomes. Collectively, the data demonstrate consistent stone clearance, high aspiration efficiency, and safety outcomes across a broad range of case complexity and clinical settings.

Across the presentations, investigators reported faster stone removal^1,2, reliable safety in the real world³, high stone clearance^1,3, and advantages associated with reducing post-operative unplanned events.⁴

Several analyses also evaluated how the CVAC System’s integrated irrigation and aspiration design contributed to consistent and faster fragment clearance compared to suction sheaths and direct-in-scope suction (DISS).

“We're seeing a high degree of consistency across clinical studies, practicing physicians, and practice settings,” said Jacqueline Welch, MD, PhD, Vice President, Medical and Clinical Affairs at Calyxo. “We now have evidence from a large number of real-world procedures demonstrating that the CVAC System delivers efficient stone clearance for a broad range of stone burdens. For patients, more complete stone clearance has important implications beyond the procedure itself, particularly in reducing downstream stone-related events.”

Comparative Study Highlights CVAC System Efficiency Despite Greater Stone Burden Relative to Suction Sheaths

Multicenter Comparison of Stone Clearance with CVAC Aspiration Ureteroscope and Flexible and Navigable Ureteral Access Sheaths¹

Jackson Cabo, MD, Endourology Fellow, Mayo Clinic, Arizona presented results from this retrospective multicenter analysis conducted by the EDGE Consortium, which evaluated the efficacy, procedural efficiency, and safety of the CVAC System compared to suction sheaths in 493 patients. Results show that:

• Patients treated with the CVAC System had approximately twice the pre‑operative stone volume yet achieved greater absolute stone clearance.
• The CVAC System delivered consistent stone removal across stone burdens, whereas suction sheath outcomes worsened with increasing stone burden (p<0.001).
• Aspiration efficiency with the CVAC System was 43% higher, even with greater case complexity in the CVAC System arm.

Benchtop Study Reveals Faster Fragment Clearance with the CVAC System Compared to DISS

Significant Outcome Difference Between Renal Stone Suction Evacuation Techniques: Controlled In Vitro Comparison of SURE vs DISS²

In this in vitro controlled bench study, Brett Johnson, MD, Associate Professor, Department of Urology, UT Southwestern Medical Center, evaluated aspiration efficiency and clearance dynamics of the CVAC System and DISS using stone fragments ranging in size from 20 µm to 3.3 mm under fixed irrigation and suction. Results show that:

• Faster fragment clearance was observed across all size groups compared to DISS. For the group with a median fragment size of 640 µm, the CVAC System was ~7.6 times faster than the 5.1 Fr DISS scope and ~17 times faster than the 3.6 Fr DISS scope.
• Median clearance time was 49 seconds with the CVAC System, while the DISS devices failed to clear the target stone fragments within the standardized 180-second study window.
• The CVAC System’s unique continuous dual‑lumen irrigation–suction enabled ongoing fragment fluidization and evacuation, whereas single-lumen DISS devices demonstrated frequent stagnation and incomplete clearance, particularly with fragments >460 µm.
• The efficiency advantage was driven by the CVAC System’s unique design and is not user‑dependent.

Large Real-World Study Demonstrates CVAC System Efficacy and Safety Outcomes Consistent with Prior Clinical Trials

Multicenter real-world outcomes of SURE with CVAC 2.0: The REASON study³

Study investigator Roger Sur, MD, Professor of Urology and Director, Comprehensive Kidney Stone Center, UC San Diego Health, presented results from this retrospective, multicenter analysis of 789 patients treated with the CVAC System. Among these patients, the median baseline stone burden was 14 mm, and the median baseline stone volume was 486 mm³. Results show:

• High stone clearance (~97%) with low residual stone volume.
• Rare intraoperative complications (<1%) and no device-related postoperative adverse events.
• Safety outcomes consistent with prior controlled studies, reinforcing confidence in CVAC System use at scale.

“Demonstrating a strong safety profile across nearly 800 patients with high stone clearance in those patients with follow-up imaging is an important real-world finding,” noted Dr. Sur. “The REASON study adds to the established evidence supporting the safety and consistency of the CVAC System across a broad patient population.”

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 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.

1. Cabo et al. Multicenter Comparison of Stone Clearance with CVAC Aspiration Ureteroscope and Flexible and Navigable Ureteral Access Sheaths. Conference Presentation AUA 2026.

2. Johnson et al. Significant Outcome Difference Between Renal Stone Suction Evacuation Techniques: Controlled In Vitro Comparison of SURE vs DISS. Conference Presentation AUA 2026.

3. Sur et al. Multicenter real-world outcomes of SURE with CVAC 2.0: The REASON study. Conference Presentation AUA 2026.

4. Johnson B. Residual Stone Volume, Rather Than Stone-Free Status, Predicts Downstream Healthcare Utilization After Ureteroscopy: Secondary Analysis of the ASPIRE Trial, Conference Presentation AUA 2026.