ONWARD Medical N.V. has received CE Mark certification for its ARC-EX System under the European Union Medical Device Regulation (MDR). The certification allows the company to promote the ARC-EX System use in conjunction with functional task practice to improve hand strength and sensation in adults with a chronic, non-progressive neurological deficit from an incomplete spinal cord injury (C2-C8 inclusive).

The CE Mark certification allows marketing for both clinic and home use. The ARC-EX System is non-invasive and delivers programmed, transcutaneous electrical spinal cord stimulation through electrodes placed on the back of the neck.

“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,” ONWARD Medical CEO Dave Marver stated. “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.” 

The ARC-EX System is supported by a unique body of clinical evidence. Results of the Up-LIFT pivotal study published in Nature Medicine showed that 90% of study participants improved strength or function, 87% reported improvement in quality of life, and benefits were observed up to 34 years post-injury. The study also reported less spasm frequency, improved sleep quality, and improved upper body sensation and sense of touch. Additionally, results of the investigator-sponsored Pathfinder2 Study, published in Neuromodulation: Technology at the Neural Interface, showed that ARC-EX Therapy, combined with activity-based rehabilitation, delivered significant functional improvements and continued gains in upper body strength, trunk control, and balance after one year of treatment, with no plateau in therapeutic benefit.¹

As part of the CE Mark application process, ONWARD Medical achieved its first certification in accordance with the European Medical Device Regulation (MDR), meeting European standards and requirements relating to patient safety, clinical performance, risk management, and post-market surveillance.

Earlier this year, the company initiated the phased launch of the ARC-EX System in U.S. clinics after U.S. Food and Drug Administration (FDA) clearance. ONWARD Medical recently reported having met its commercial objective for the first half of 2025, with positive feedback and strong demand from its initial users. The ARC-EX System was selected as a TIME Magazine Best Invention in 2024 and was also recognized as one of Fast Company’s 2025 World Changing Ideas for its potential to transform lives.

ONWARD Medical is a neurotechnology company pioneering therapies to restore movement, function, and independence in people with spinal cord injuries and other movement disabilities. Building on decades of scientific discovery, preclinical research, and clinical studies conducted at hospitals, rehabilitation clinics, and neuroscience laboratories, the company developed ARC Therapy. It has subsequently been awarded 10 Breakthrough Device Designations from the FDA. ONWARD Medical is also developing an investigational implantable system called ARC-IM, designed to address several unmet needs including blood pressure instability after spinal cord injury. It can also be paired with a brain-computer interface (BCI) and artificial intelligence (AI) to restore thought-driven movement.

Headquartered in the Netherlands, the company has a Science and Engineering Center in Switzerland and a U.S. office in Boston. All other ONWARD Medical devices and therapies including ARC-IM and ARC-BCI are investigational and not available for commercial use.

Reference
¹ ARC-EX Indication for Use (EU): The ARC-EX System is intended to deliver programmed, transcutaneous electrical spinal cord stimulation in conjunction with functional task practice in the clinic and with take-home exercises in the home to improve hand sensation and strength in individuals between 18 and 75 years old that present with a chronic (>1 year post-injury), non-progressive neurological deficit resulting from an incomplete spinal cord injury (C2-C8 inclusive).