ONWARD Medical Gains CE Mark Approval for ARC-EX Spinal Cord Stimulation System

ONWARD Medical N.V. has secured CE Mark certification for its ARC-EX System under the European Union Medical Device Regulation (MDR), enabling the commercial launch of the device in Europe and selected international markets.

The non-invasive ARC-EX System delivers programmed transcutaneous electrical stimulation to the spinal cord via electrodes placed on the back of the neck. 

It is designed for use alongside functional task practice to enhance hand strength and sensation in adults with a chronic, non-progressive neurological deficit following an incomplete spinal cord injury at levels C2–C8. The certification allows the device to be marketed for both clinical and home use.

ARC-EX is supported by extensive clinical evidence. Results from the pivotal Up-LIFT study published in Nature Medicine showed that the majority of participants experienced improved strength or function, with many also reporting better quality of life, reduced spasm frequency, improved sleep, and enhanced upper body sensation.
 
Findings from the Pathfinder2 Study, published in Neuromodulation: Technology at the Neural Interface, demonstrated that combining ARC-EX Therapy with activity-based rehabilitation delivered sustained gains in upper body strength, trunk control, and balance after one year of treatment without a plateau in benefits.

The CE Mark represents ONWARD Medical’s first certification under the MDR, confirming compliance with European requirements for safety, clinical performance, risk management, and post-market surveillance.