Onward Medical announced today that it received CE mark for its ARC-EX spinal cord stimulation (SCS) 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 spinal cord injury (SCI).
Eindhoven, The Netherlands–based 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.
Now, the company can begin commercial efforts in Europe. CE mark enables Onward to promote the use of ARC-EX in conjunction with functional task practice to improve hand strength and sensation in adults with a chronic, non-progressive neurological deficit resulting from an incomplete spinal cord injury (C2-C8 inclusive).
Onward said CE mark allows certification for both clinic and home use. The company supported its regulatory submission with clinical evidence from both the Up-LIFT pivotal study and Pathfinder2 study.
“Hand sensation and strength is a primary recovery target after spinal cord injury. The ARC-EX Therapy opens new doors for the SCI community in Europe, offering opportunities for recovery and care that were previously unavailable,” said Dave Marver, Chief Executive Officer of ONWARD Medical. “The CE Mark certification for ARC-EX was awarded far earlier than expected and it gives us great satisfaction to bring this important new therapeutic option to the European spinal cord injury community. We will initiate a phased launch in Europe in the coming weeks, starting with Germany, and cascading to other countries as soon as possible thereafter.”
