# Commercialization of Low-Cost Portable 3D Ultrasound for Surveillance of Arteriovenous Fistula Maturation by Point-of-Care Dialysis Clinicians

> **NIH NIH SB1** · SONAVEX, INC. · 2022 · $500,000

## Abstract

PROJECT SUMMARY/ABSTRACT
Severe kidney disease accounts for 7% of all Medicare and Medicaid costs. The most cost-effective way to
perform dialysis uses an arteriovenous fistula to connect to dialysis machines, but fistula use is limited by the
malfunctions immediately following creation (maturation failure), which can render up to 70% of all created
fistulas unusable.
Ultrasound monitoring of the fistula after it has been created can avoid malfunction by detecting problems that
can be fixed with minimally invasive outpatient procedures. Unfortunately, though ultrasound has been shown to
reduce the failure rate to only 22%, the ultrasounds examinations used to detect these problems are very
expensive because they can only be performed at specialized vascular laboratories by ultrasound specialists –
not in the dialysis clinic. Additionally, dialysis patients are only 12-33% compliant with visits outside of routine
dialysis sessions due to transportation and financial limitations. Because of the significant expense and logistical
challenges, ultrasound scans are not currently routinely performed in the postoperative period. If ultrasound were
less expensive, more accessible, and available in the dialysis clinic, it could be performed during the maturation
phase and eliminate most early fistula failures, minimize catheter contact time, resulting in significant clinical
benefit for patients and substantial cost savings.
We have developed a dual-component ultrasound-based solution, EchoMark LP and EchoSure V2, that can be
utilized anywhere and does not require expert ultrasonographers. Our system can be used to examine a fistula
during routine dialysis sessions by the same dialysis techs that are administering dialysis. This means that
ultrasound monitoring of a fistula in the first few weeks after fistula creation can be done for little additional cost
as often as 3 times per week. We have proven that EchoSure V1 works in human fistulas and we have received
FDA clearance, however the device must be modified for commercial viability. Specifically, we must: 1) lower
ultrasound system cost, based on recognition of a need to install a larger number of systems at dialysis centers;
2) increase portability, based on clinician feedback on the need to easily transport the system between locations
(e.g. home hemodialysis); and 3) integrate with common PACS/EMRs like Epic to enable streamlined weekly
documentation of fistula flow data and billing for reimbursement.
In this work we propose to develop a new version of the EchoSure system (ESV2) to meet these needs. This
will allow rapid, accurate and frequent surveillance of arteriovenous fistulae in any setting (e.g. dialysis unit,
home, clinic, etc.) to maximize maturation rates and prevent fistula failure.
In this CRP proposal, we will (1) develop a new hardware solution for the ultrasound system and 3D transducer
which decreases cost by 50%, reduces form factor size and weight, and enables ease of transportati...

## Key facts

- **NIH application ID:** 10480217
- **Project number:** 2SB1HL147423-07A1
- **Recipient organization:** SONAVEX, INC.
- **Principal Investigator:** Xin Kang
- **Activity code:** SB1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $500,000
- **Award type:** 2
- **Project period:** 2019-07-01 → 2024-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10480217

## Citation

> US National Institutes of Health, RePORTER application 10480217, Commercialization of Low-Cost Portable 3D Ultrasound for Surveillance of Arteriovenous Fistula Maturation by Point-of-Care Dialysis Clinicians (2SB1HL147423-07A1). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10480217. Licensed CC0.

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