RIVANNA initiates multi-site first-in-human study for Accuro XV musculoskeletal imaging system

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Oct 10, 2024, 14:00 ET

CHARLOTTESVILLE, Va., Oct. 10, 2024 /PRNewswire/ -- RIVANNA®, developers of imaging-based medical solutions, has announced the launch of the first multi-site study employing the Accuro® XV musculoskeletal imaging system. This milestone follows a $30.5 million funding option executed in 2023 by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS).

Over 20 million patients present to emergency departments (ED) annually with suspected distal extremity trauma, and an estimated 90% to 99% receive X-ray imaging, according to The Journal of Emergency Medicine. However, it is reported that in the lower leg, the incidence of fractures ranges between 8% to 19%, and in the distal arm, the incidence is between 25% to 57%, according to The Journal of Trauma and Acute Care Surgery and The American Journal of Emergency Medicine. A bedside triage device like Accuro XV may significantly reduce the utilization of radiological resources for low-acuity injury triage.

This feasibility study, enrolling 200 participants, aims to acquire fracture images with Accuro XV to evaluate device safety, ability to integrate within ED workflow and the system's ability to render automated diagnostic ultrasound images.

Accuro XV integrates ultrasound-based bone and 3D soft-tissue imaging technology with AI-enabled software and is designed to enable rapid automated detection and volumetric assessment of skeletal fractures and soft tissue injuries without harmful radiation exposure. Additionally, Accuro XV aims to address limitations in EDs such as identifying soft tissue injuries during the acute phase, ensuring accurate treatment decisions and prompt discharge of those not needing further intervention.

"Since October 2021, we have quickly progressed from design to proof of concept in clinical sites, thanks to our collaboration with BARDA," said Delphine Le Roux, PhD, PMP, Director of Program Management. "Study data will expedite the development of Accuro XV for comprehensive point-of-care musculoskeletal diagnostics and validate product design with ED physician end-users."

UVA Health worked with RIVANNA at the study's inception, providing study start-up and optimization before expanding to The University of Texas Southwestern Medical Center, where faculty treat patients at Parkland Memorial Hospital, one of the nation's busiest EDs with 240,000 visits annually.

"We are working to transform technological opportunities into applications that may improve treatment for low-acuity patients and reduce wait times," said Chris Thom, MD, RDMS, Associate Professor of Emergency Medicine at the University of Virginia School of Medicine.

This project has been supported in whole or in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response (ASPR); Biomedical Advanced Research and Development Authority (BARDA), under contract number 75A50121C00035. About BARDA.

About RIVANNA
RIVANNA® is a commercial-stage medical device innovator and manufacturer in Charlottesville, VA. RIVANNA's mission is to develop and commercialize world-first imaging-based medical technologies that elevate global standards of care. RIVANNA is privately held and operates an FDA-registered and ISO 13485:2016-certified manufacturing facility. Learn more: RIVANNA.

SOURCE RIVANNA