The first commercial sale comes less than a month after the Eindhoven, The Netherlands-based company won FDA approval for the system.
ARC-EX SCS therapy delivers targeted, programmed electrical stimulation transcutaneously to the spinal cord. The technology uses electrodes placed on the back of the neck for non-invasive therapy without the need for surgery. It enables increased strength, movement and function in the upper limbs after SCI.
Results from the company’s Up-LIFT study showed that ARC-EX achieved all primary safety and effectiveness endpoints. Additionally, ARC-EX showed significant improvements in upper limb strength, function and sensation. That study looked at subjects with chronic tetraplegia due to cervical spinal cord injury (SCI).
Onward said FDA clearance covers the use of ARC-EX in clinics and it anticipates home use authorization in mid-2025. It also plans to seek CE mark in Europe, anticipating that regulatory nod in the second half of 2025. The company has a pipeline of technologies, including its implantable ARC-IM SCS system. It also has an investigational platform that uses a brain-computer interface (BCI) powered by AI.
Onward made the sales to the University of Washington School of Medicine and Next Steps Chicago.
“The first commercial sales of our ARC-EX System are a pivotal moment in our mission to help people with spinal cord injury, demonstrating our ability to successfully translate scientific discovery into real-world impact for people with spinal cord injury,” said Dave Marver, CEO of Onward Medical.
