ONWARD Medical NV
THIS PRESS RELEASE CONTAINS INSIDE INFORMATION WITHIN THE MEANING OF ARTICLE 7(1) OF THE EUROPEAN MARKET ABUSE REGULATION (596/2014)
The CE Mark certification allows marketing for both clinic and home use
First commercial sales of the ARC-EX® System in Europe are expected in Q4 2025
The CE Mark enables commercialization in the European Union and facilitates a streamlined regulatory pathway in other countries, including in the UK and Switzerland
EINDHOVEN, the Netherlands, Sept. 08, 2025 (GLOBE NEWSWIRE) — ONWARD Medical N.V. (Euronext: ONWD – US ADR: ONWRY), the leading neurotechnology company pioneering therapies to restore movement, function, and independence in people with spinal cord injuries (SCI) and other movement disabilities, today announced it has received CE Mark certification for its ARC-EX System under the European Union Medical Device Regulation (MDR), enabling commercialization 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 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.”
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 benefit1.
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