Validation Study of Sonavex’s EchoMark® & EchoSure® Performance for Measuring AV Fistula Maturation Parameters Published in Journal of Vascular Access

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The prospective study demonstrated that when used by dialysis technicians and nurses, EchoSure’s measurements were both accurate and precise.

Sonavex, Inc., a privately held medical device company with ultrasound technologies that deliver quantitative blood flow and other critical vascular data at the point of care, announced today the publication of a new peer-reviewed study validating the performance of its EchoSure device in the Journal of Vascular Access. The use of ultrasound in the dialysis clinic to assess maturation holds great promise to improve patient outcomes, but its availability has traditionally been limited by the specialized skill set required to operate conventional ultrasound. The published study was a prospective, head-to-head comparison of EchoSure in the hands of health care workers with no prior experience using ultrasound – dialysis technicians and registered nurses – versus the gold standard of Duplex ultrasonography performed by trained, certified vascular sonographers. A total of 25 participants collected volumetric flow rate, diameter, and depth measurements in a clinically representative benchtop AV fistula model across morphologies and flow rates seen during fistula maturation.

Both Duplex and EchoSure performed within the expected tolerance of ultrasound readings (35%) for volume flow, with the average error between the observed measurement and the ground truth being 8% for Duplex and 8% for EchoSure. However, the average coefficient of variation (CV) for Duplex pooled over all flow rate measurements was 17% versus 4% for EchoSure. Across assessments of volume flow, diameter and depth, EchoSure demonstrated similar or better accuracy when compared to Duplex and was more precise than Duplex. Additionally, the technicians and nurses using EchoSure acquired data 62% faster than the expert sonographers using the Duplex ultrasound.

“It is encouraging to see that EchoSure results, when collected by representative users in the dialysis clinic, were as accurate and more precise than standard Duplex,” commented Dr. Alex Yevzlin, Chief Medical Officer of Sonavex. "These findings validate our core technology, and we are excited to see the results published. We believe EchoSure offers great promise in bringing valuable information directly to the care team. We are excited to further evaluate the impact EchoSure can have on patient well-being and vascular access outcomes via our IDE study."

This research was supported by the National Heart, Lung, And Blood Institute of the National Institutes of Health under Award Number R44HL147423. The content in this release is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health

The full publication is linked here: https://journals.sagepub.com/doi/full/10.1177/11297298221074462

About Sonavex, Inc.
Sonavex, Inc. is a Baltimore-based medical device company originally spun out of Johns Hopkins. The company has developed a portfolio of novel ultrasound solutions that empower patient care by delivering critical visual and quantitative data to improve outcomes and reduce costs. For more information, please visit http://www.sonavex.com.

Media Contact:
Sonavex, Inc.
Email: contact@sonavex.com
Phone: (443) 862-2020

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David Narrow