Rivanna Medical, a Charlottesville, VA-based developer of imaging-based medical solutions, received funding totaling $30.5m 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.
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 $11.6m 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.
Led by Will Mauldin, PhD, co-founder and CEO, Rivanna is elevating global standards of care through the development and commercialization of imaging-based medical technologies, including BoneVision™ Multi-Probe Multi-Angle Image Acquisition, BoneEnhance® Multi-Frequency Image Reconstruction, and SpineNav3D™ AI-Enabled Spine Recognition. Its complete clinician-assistance solutions improve decision-making, workflows, health outcomes, and patient satisfaction.
FinSMEs
28/07/2023