The cost-share agreement will fund development and FDA clearance of the OXOS X3, a next-generation device designed for point-of-need imaging in emergency and mass casualty settings.
OXOS Medical has been awarded a $9.6 million base cost-share contract by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the US Department of Health and Human Services, to develop and seek US Food and Drug Administration (FDA) clearance for its next-generation ultra-portable X-ray system, the OXOS X3.
The total contract is valued at up to $24.4 million if all options are exercised. OXOS will match BARDA’s funding dollar for dollar, bringing the total potential project value to $48.9 million.
The X3 is designed to deliver imaging directly to patients at the bedside, in clinics, or in field settings, reducing reliance on fixed radiology infrastructure in emergency departments and outpatient facilities. The device is built on the FDA-cleared OXOS MC2, which is already in use across clinics, hospitals, and military and VA facilities.
Supporting Response to Mass Casualty Events
In a mass casualty event—including chemical, biological, radiological, and nuclear incidents—the X3 is intended to help clinicians rapidly detect fractures and other traumatic injuries to inform triage decisions about who needs care first.
“When disaster strikes, the ability to image a patient quickly can determine who gets care first. We are proud to partner with BARDA to help bring the OXOS X3 into clinicians’ hands. Our goal is high-quality X-ray imaging that can go wherever patients are,” says Evan Ruff, CEO of OXOS Medical, in a release.
Scope of the Development Program
Under the contract, OXOS will carry out the full development program for the X3, including product development, verification and validation, design transfer to manufacturing, and human factors studies. The work will support regulatory activities for FDA submission and the launch of first commercial shipments.
The OXOS X3 remains under development, has not received FDA clearance, and is not currently offered for sale.
The project is being supported in whole or in part with federal funds from HHS and BARDA under contract number 75A50126C00011.
