Vexev's VxWave System Successfully Meets Clinical Endpoints in Landmark Study Evaluating Robotic Ultrasound Scanning for Mapping Vascular Access at U.S. Renal Care Dialysis Clinics

• VxWave Ultrasound Imaging System demonstrated 94% scanning success rate and 100% data adequacy rate for vascular access creation strategies in CANSCAN trial
• New insights into vascular anatomy made possible by standardized image acquisition and reporting
• VxWave System has the potential to significantly advance standardization of vascular assessment at the point of care

SYDNEY and SAN ANTONIO, Nov. 11, 2025 /PRNewswire/ -- Vexev, an Australian-based medical device company advancing next-generation vascular imaging, and U.S. Renal Care, a leading provider of in-center and home dialysis in the United States, announced the highly successful results of the CANSCAN Trial (NCT06691672), providing evidence that the VxWave Ultrasound Imaging System can reliably perform semi-autonomous vascular mapping examinations directly within the dialysis clinic. Dr. Varshi Broumand, CANSCAN Study Principal Investigator, presented the results during the American Society of Nephrology's annual meeting, Kidney Week 2025, in Houston, Texas (November 5-9).

"Functioning vascular access is a lifeline for patients on hemodialysis, yet nearly 3 out of 4 arteriovenous fistulas (AVF) fail to mature or are abandoned before use. While traditional vascular mapping scans have improved vascular access, they suffer from poor patient compliance due to being scheduled outside of dialysis appointments, often lack standardized quality and are expensive," explained Dr. Broumand, Interventional Nephrologist at South Texas Renal Care Group. "The CANSCAN Trial highlights the potential that with the robotic VxWave System, we can finally bring high-quality vascular imaging on-demand in the dialysis clinic, overcoming barriers of cost, compliance, and variability that have limited patient outcomes for far too long."

The first-of-its-kind, multi-center feasibility trial scanned 115 patients with severe kidney damage or end stage renal disease (CKD stage 4 and 5 patients) and the primary endpoints demonstrated:

• 94% Scan Completion Rate (SCR)
• 100% Data Adequacy Rate (DAR)¹
• 98% of Access Options² determined feasible in patients

The VxWave System is a robotic tomographic ultrasound imaging system specifically designed for upper limb vascular imaging to be delivered on-demand at the point of care. The system integrates advanced robotics, machine learning and ultrasound signal processing to create a 3D vascular model and detailed report that aims to provide insights into vascular access points for hemodialysis.

"The success of the CANSCAN Trial confirms that standardized, high-quality, point-of-care vascular assessment may now be achievable," said Shannon Thomas, MD, Chief Medical Officer, Vexev. "The trial represents a significant step towards the future of standardized vascular assessment across the globe, allowing us to plan vascular access for hemodialysis with data-driven precision, especially for higher risk patients whose anatomical factors may complicate traditional planning."

Beyond providing evidence of feasibility, the CANSCAN trial provided insights into the upper limb vascular anatomy of CKD stage 4 and 5 patients and identified subgroups who may be at a disadvantage for vascular access creation. Specifically, patients with diabetes had significantly more calcification in the upper limb arteries and a reduction in forearm distal vascular diameters. Furthermore, female patients were found to have statistically fewer available veins and smaller veins overall compared to males.

The VxWave system's potential ability to standardize examinations would allow dialysis clinics to better determine subgroups who may be at a disadvantage for vascular access creation, ultimately aiming to reduce the high rates of access failure and dialysis dysfunction currently experienced by patients.

"This is one of the more promising innovations we've seen recently, and the results are encouraging," said Geoff Block, MD, FASN, Associate Chief Medical Officer and Senior Vice President, Clinical Research & Medical Affairs for U.S. Renal Care. "They suggest real potential to improve patient outcomes. As access expands, we're interested to see how an automated point-of-care imaging approach can enhance care across our network." 

About VexevVexev is an Australian med‑tech startup founded in 2018 by Dr. John Carroll and Dr. Eamonn Colley, experts in vascular fluid dynamics and computational imaging, dedicated to transforming blood-flow research into technology that improves vascular and renal health outcomes. Vexev is on a mission to improve lives by developing the next generation of vascular imaging solutions. Visit Vexev.com to learn more.

About U.S. Renal CareU.S. Renal Care, the fastest-growing dialysis provider in the nation, partners with nephrologists across 32 states in the U.S. to care for more than 36,000 people living with kidney disease. Since 2000, U.S. Renal Care has been a leader in clinical quality, innovation, and operational excellence - delivering the best experience and outcomes for our patients. Visit USRenalCare.com to learn more.

¹ The image quality of all successful scans was reviewed and deemed adequate by an independent panel of more than two vascular access specialists.² Access options include arteriovenous graft (AVG) or arteriovenous fistula (AVF)

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