Calyxo, Inc., is a 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. The company's innovative CVAC Aspiration System utilizes irrigation and aspiration to remove kidney stones with the goal of a surgically stone-free outcome. Historically, that outcome has been difficult to achieve consistently.

Approximately 10% of people in the U.S. will have a kidney stone at some point in their lives, according to the American Urological Association. Kidney stone disease is a painful condition that brings with it significant healthcare costs. The most commonly used kidney stone treatments today do not reliably remove all of the stone fragments created. Earlier this year, Calyxo announced 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, reliable safety in the real world, high stone clearance, and advantages associated with reducing post-operative unplanned events. 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). In one example, Jackson Cabo, M.D., Endourology Fellow, Mayo Clinic, Arizona presented results from a 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). Moreover, aspiration efficiency with the CVAC System was 43% higher, even with greater case complexity in the CVAC System arm.

“We’re seeing a high degree of consistency across clinical studies, practicing physicians, and practice settings,” according to Jacqueline Welch, M.D., Ph.D., Vice President for 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.”

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.

The company, which has been a Hacienda tenant since May 2020, closed a $40 million Series F financing round in April following a key company milestone: 40,000 patients treated with the CVAC System. Adoption of Calyxo’s all-in-one aspiration-based stone removal system reflects increasing clinician recognition that more complete stone clearance leads to improved patient outcomes. Proceeds from the financing are being used to expand Calyxo’s commercial infrastructure, advance clinical and health economic evidence generation through ongoing and future studies evaluating long-term outcomes and downstream healthcare utilization, and support continued innovation in kidney stone care.

For more information about Calyxo, Inc., please visit calyxoinc.com.