Onward secures FDA Clearance to expand home use of spinal cord system

Onward Medical has secured FDA 510(k) clearance expanding ARC-EX for home use, widening access to non-invasive spinal cord stimulation for people with upper-limb deficits after spinal cord injury.

ARC-EX spinal cord stimulation therapy delivers targeted, programmed electrical stimulation through the skin to the spinal cord.

Electrodes placed on the back of the neck provide non-invasive therapy without surgery, aiming to increase upper-limb strength, movement and function after SCI.

Onward won FDA approval for the system in December 2024. The company made the first commercial sales of ARC-EX in the US in January.

It also won CE mark for ARC-EX in September, which already included home use.

Dave Marver, chief executive of Onward Medical, said: “Today’s authorisation expanding the ARC-EX system indication for home use greatly enlarges the US market opportunity and is a defining milestone for the spinal cord injury community,.

“People living with SCI will now be able to benefit from use of the ARC-EX system in the comfort and convenience of their own homes.”

Previously, the FDA cleared ARC-EX for use with functional task practice in the clinic and take-home exercises in the home to improve hand strength and sensation in adults with chronic, non-progressive neurological deficits from an incomplete SCI (C2–C8 inclusive).

The company supported its latest regulatory submission with clinical evidence from the Up-LIFT pivotal study and the Pathfinder2 study.

ARC-EX is currently accessible in more than 60 clinics across the US within less than a year of commercial availability.