ONWARD Medical N.V., the leading neurotechnology company pioneering therapies to restore movement, function, and independence in people with spinal cord injuries (SCI) and other movement disabilities, announced it has received CE Mark certification for its ARC-EX System under the European Union Medical Device Regulation (MDR), enabling commercialisation in the European Union and certain other countries.

This certification enables the Company to promote the use of the ARC-EX System 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). The certification allows marketing for both clinic and home use. The ARC-EX System is non-invasive and delivers programmed, transcutaneous electrical spinal cord stimulation via electrodes placed on the back of the neck.

“Hand sensation and strength a primary recovery targets 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."