In our February 2025 Insurance Insights we reported on spinal cord injury (SCI) research developments to watch. One such development was ARC-EX therapy, at the time authorised for clinical use in the United States but CE Mark certification was being requested with a commercial launch in Europe expected in 2025. We can now report that in September, Onward Medical, a Netherlands headquartered company, was the first to obtain CE Mark certification in Europe for ARC-EX, a system designed specifically to improve hand and arm strength and sensation in adults with chronic, incomplete spinal cord injury. ARC-EX is promoted for use in conjunction with standard rehabilitation practices. It joins other SCI therapies on the European market, including Aneuvo’s ExaStim, which is indicated for restoring motor function in individuals with chronic SCI.
Secured under the European Union’s Medical Device Regulation (EU MDR), ARC-EX delivers electrical spinal cord stimulation for SCI via electrodes attached to the neck, offering an external non-invasive treatment option.
According to the World Health Organization, SCI affects around seven million people worldwide. Onward Medical said a phased roll-out of ARC-EX in Europe will start in Germany, with other countries to follow “as soon as possible”.
Onward’s CEO, Dave Marner, commented: “Hand sensation and strength is a primary recovery target after SCI. The ARC-EX Therapy opens new doors for the SCI community in Europe, offering opportunities for recovery and care that were previously unavailable.”
90% of patients who used ARC-EX reported improved strength or function, with 87% reporting improvement in quality of life. Other study findings included reports of reduced spasm frequency, improved sleep quality and enhanced upper body sensation and sense of touch. Onward Medical highlighted that benefits were observed in patients with injuries that occurred up to 34 years ago.
The certification for commercial use in Europe is a significant step forward to make the ARC-EX treatment more widely available and to change the lives of people with SCI.
According to a report by Global Data, Onward Medical has nine further neurology devices in active stages of development, including ARC-IM, an implantable system designed to address blood pressure instability and other symptoms in people with SCI. In 2020, Onward Medical received FDA Breakthrough Device Designation for ARCIM to restore leg motor function in people with spinal cord injury. This was followed by approval of systems to normalize blood pressure and provide trunk stability in 2021, for bladder control in 2022 and for reduced spasticity in 2023. Other potential technologies that Onward Medical says it may explore include those relating to improving bowel control, Parkinson’s mobility and gait and sexual function.
Groundbreaking ongoing research is also undertaken in the UK. Earlier this year, the BBC reported that a Kent man paralysed from the waist down had partially regained bowel and bladder control thanks to breakthrough ARC-EX therapy as part of UK research.
Dan Woodall, from Rainham, was paralysed in 2016 after falling from a bypass after a night out. The 33-year-old was one of ten people who took part in a Pathfinder2 trial funded by charity Spinal Research, using electrical stimulation to "excite" the spinal cord and create movement. Mr Woodall has said:
"[The trial] gave me back control over muscle groups I never thought I'd move again, including my right hamstrings and hip flexors". I've also regained some bowel and bladder control - something I was told in hospital after my accident might never happen. Just knowing when you want to use the toilet is such a massive thing for your independence and mental health. The fact that the gains have continued after the trial is really encouraging and I can't wait to see where this goes."
The participants took part in 120 sessions using the ARC-EX. All saw significant improvements in upper body strength, torso control and balance, according to Spinal Research.
Spinal Research chairwoman Tara Stewart said:
"This therapy is not a silver bullet.
"It works on spared spinal tissue so results will vary widely, and it does need to be paired with proper active rehabilitation over a consistent period of time.
"Even so, this is a game changing moment. It's now time to stop talking about spinal cord injury as being incurable and to stop telling people with this injury that nothing can be done."
The peer-reviewed study had been published in Neuromodulation: Technology at Neural Interface.
Scientific developments combined with technological advances and architectural innovation can now give someone with SCI hope of a much better quality of life and, from a claims perspective, reduce overall future costs. For our Spinal Technical Injury Unit articles on exoskeletons and modular pods, see here.
For any queries, please contact Patricia Williams, Legal Director, in our Spinal Technical Unit.
