Onward Medical announced today that it received FDA 510(k) clearance to expand the ARC-EX system’s indication for home use. ARC-EX spinal cord stimulation (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 spinal cord injury (SCI).
Onward won FDA approval for the system in December 2024. The company made the first commercial sales of ARC-EX in the U.S. in January. It also won CE mark for ARC-EX in September, with that regulatory nod already including home use.
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Previously, the FDA cleared ARC-EX for use in conjunction 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 resulting from an incomplete SCI (C2-C8 inclusive).
The company supported its latest regulatory submission with clinical evidence from both the Up-LIFT pivotal study and the Pathfinder2 study. ARC-EX is currently accessible in more than 60 clinics across the U.S. through less than one year of commercial availability.
“Today’s authorization expanding the ARC-EX system indication for home use greatly enlarges the U.S. market opportunity and is a defining milestone for the spinal cord injury community,” said Dave Marver, CEO of Onward Medical. “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.”
