ONWARD Medical Receives CE Mark for ARC-EX®
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ONWARD Medical, a Vaud-Based neurotechnology company, has achieved a major milestone with the CE Mark certification of its ARC-EX® System. This approval allows the company to launch its breakthrough spinal cord stimulation therapy across Europe, both for clinical and home use. The first commercial sales are expected in Q4 2025, starting in Germany before expanding to other countries, including Switzerland and the UK.
What the ARC-EX® System Does
The ARC-EX System is a non-invasive device designed to restore hand strength and sensation in adults living with incomplete spinal cord injuries.
- It uses electrical stimulation, delivered through small electrodes placed on the back of the neck.
- The therapy is combined with functional task practice, helping people regain movement and independence.
“Hand sensation and strength are top recovery goals for people with spinal cord injuries,” said Dave Marver, CEO of ONWARD Medical. “This approval brings new hope to the SCI community in Europe.”
Strong Clinical Evidence
The CE Mark was supported by promising results from key studies:
- Up-LIFT Study (published in Nature Medicine):
- 90% of participants gained strength or improved function
- 87% reported better quality of life
- Benefits observed even 34 years after injury
- Fewer spasms, better sleep, and improved touch sensation
- Pathfinder2 Study (published in Neuromodulation):
- Continued gains in upper body strength, balance, and trunk control over one year
- No plateau in therapeutic benefits
With this approval, ONWARD Medical is set to bring new possibilities for recovery and independence to thousands of people living with spinal cord injuries across Europe.
Earlier this year, the Company initiated the phased launch of the ARC-EX System in US clinics following US Food and Drug Administration (FDA) clearance. The Company 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 it was also recognized as one of Fast Company’s 2025 World Changing Ideas for its potential to transform lives.
About Onward Medical
ONWARD Medical is the leading 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 leading hospitals, rehabilitation clinics, and neuroscience laboratories, the Company developed ARC Therapy. It has subsequently been awarded 10 Breakthrough Device Designations from the FDA. The Company’s ARCEX® System is cleared for commercial sale in the US and Europe. The Company 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 Lausanne, Switzerland and a US office in Boston, Massachusetts.