Rivanna, developers of imaging-based medical solutions, has received a contract from the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS), for the design and development of a computer-aided 3D fracture detection and diagnosis product, called Accuro XV.
Under the contract, HHS/ASPR/BARDA will provide $11.6 million over 24 months with options for additional funding for supporting further development up to $65 million.
The project's overarching objective is to achieve a market-ready, clinically proven, and FDA-cleared Accuro XV product for rapid, radiation-free fracture detection and aid triage in emergency medicine; a critical medical countermeasure to ensure timely triage for reduction of morbidity and mortality in mass-casualty blast trauma incidents, for which, no field-deployable equipment for extremity fractures currently exists.
The Accuro XV is a portable medical system building on technologies that underpin Rivanna's patent portfolio, including BoneEnhance Multi-Frequency Image Reconstruction, which optimises ultrasound for the visualisation of bony versus soft-tissue anatomy. Supporting this image reconstruction technology is Multi-Probe Multi Angle BoneVision, an automated image-acquisition technique based on a series of novel three-dimensional ultrasound-based bone-imaging technologies that increases angular image sensitivity to bone surfaces. BoneVision provides precisely captured bony anatomical structures within a large field of view and demonstrated performance detecting small fractures with high sensitivity and specificity.
By automating both the image acquisition and image interpretation, Accuro XV will also support just-in-time training. The ease of use afforded by the automation aims to reduce user dependence and optimise the success of clinical evaluations for adoption in hospital and emergency room (ER) settings.
Will Mauldin, PhD, co-founder, and CEO of Rivanna, said: "We are pleased to receive this award from BARDA. With attainment of targeted product performance specifications, the clinical and economic value of Accuro XV is expected to result in an inevitable shift away from the current state of X-ray over-utilisation towards a radiation-free, bedside triage standard of care."
