CHARLOTTESVILLE, VA, JULY 26, 2023 — RIVANNA®, developers of imaging-based medical solutions, announced that they have received funding totaling $30.5 million over 39 months from early execution of an option 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). The funding will support the further advanced development of the Accuro® XV for comprehensive point-of-care musculoskeletal diagnostics as well as submission of an application for FDA clearance.
"Completing our base-stage performance milestones ahead of schedule is a testament to our organization's dedication and commitment to healthcare innovation," said Delphine Le Roux, PhD, PMP, Director of Program Management. “As a direct consequence of this accomplishment, the project received early option one funding, expediting Accuro XV's product development and initial clinical evaluations for FDA clearance. The continued support of our funding partners underscores the strong collaboration built on trust among all stakeholders involved in this effort," added Le Roux.
The contract includes options for additional funding up to $56.4 million, to support the development leading to 510(k) clearance for CADe/x artificial intelligence (AI)-enabled fracture detection. This second round of funding follows an $11.6 million base contract executed in 2021 for the proof-of-concept product development and market assessment of Accuro XV. The project aims to develop an FDA-cleared and clinically proven product to expedite triage of low-acuity extremity injuries in emergency medicine, with a particular focus on mass-casualty blast trauma incidents.
Accuro XV integrates ultrasound-based bone and 3D soft-tissue imaging technology with AI-enabled software, offering distinct advantages over traditional X-ray methods. The system is designed to enable rapid automated detection and precise volumetric assessment of skeletal fractures and soft tissue injuries without exposing patients to harmful radiation or requiring extensive user training. Clinicians may make informed decisions regarding the necessity of X-ray imaging, effectively reducing nonessential radiography. Additionally, Accuro XV may address a current limitation in emergency departments by swiftly determining soft tissue injuries during the acute phase; this would ensure accurate treatment decisions and prompt discharge of individuals who do not require further intervention.
"Receiving a second round of funding from BARDA is a major milestone in our mission to elevate the global standard of care," stated Will Mauldin, PhD, co-founder and CEO of RIVANNA. “The true value of Accuro XV lies in its ability to assess both fractures and soft tissue injuries simultaneously, which is not achievable with X-ray imaging. By providing comprehensive point-of-care musculoskeletal diagnostics, particularly in high-pressure situations, Accuro XV addresses a critical gap in emergency medical response, which enables cost-effective expedited care delivery that leads to enhanced patient satisfaction and improved outcomes."
This project has been supported in whole or in part with federal funds from the Department of Health and Human Services; the Administration for Strategic Preparedness and Response (ASPR); and the Biomedical Advanced Research and Development Authority (BARDA), under contract number 75A50121C00035. Learn more about BARDA: https://www.medicalcountermeasures.gov.
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. A patented ultrasound-based bone imaging technology powers RIVANNA’s unique value proposition: enhancing patient safety through radiation-free alternatives to X-ray-based imaging and increasing provider precision and efficiency with AI-enabled software. RIVANNA is privately held and operates an FDA-registered and ISO 13485:2016 certified manufacturing facility where it produces the Accuro® product line and related medical equipment and components. For more information, visit RIVANNA.
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