News & Press

ONWARD Medical Receives CE Mark for ARC-EX, Enabling Commercial Launch in Europe

GlobeNewsWire9/8/2025·09/08/25🌐 Europe

Summary

ONWARD Medical received CE Mark certification for its ARC-EX System under EU Medical Device Regulation, enabling commercialization in the EU for clinic and home use. The non-invasive spinal cord stimulation system improves hand strength and sensation in adults with incomplete spinal cord injury. First commercial sales in Europe expected in Q4 2025 starting in Germany.

Why it matters

CE Mark certification for ARC-EX represents a major milestone for spinal cord injury therapy in Europe, offering non-invasive restoration of hand function. The Up-LIFT pivotal study published in Nature Medicine showed 90% of participants improved strength or function.

#CE Mark#Spinal Cord Stimulation#Spinal Cord Injury#Europe#Neurostimulation

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