ONWARD Medical has achieved CE mark certification for its ARC-EX System to treat adults with a chronic, non-progressive neurological deficit due to an incomplete spinal cord injury.
ARC-EX is a non-invasive device designed to deliver programmed, transcutaneous electrical spinal cord stimulation through electrodes placed on the back of the patient’s neck.
Clinical evidence suggests that the system enhances hand strength and sensation, with studies indicating significant improvements in strength, function, and quality of life.
The approval allows ONWARD Medical to market the system across the European Union (EU) and select other regions, including the UK and Switzerland.
The Dutch medical technology company plans to begin commercial sales of the ARC-EX System for both clinic and home use during Q4 2025.
ONWARD Medical CEO Dave Marver said: “The ARC-EX Therapy opens new doors for the SCI community in Europe, offering opportunities for recovery and care that were previously unavailable.
“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.”
ONWARD Medical said that the CE Mark certification aligns with the European Union’s (EU) medical device regulation (MDR), ensuring patient safety and clinical efficacy.
The company launched the ARC-EX System in US clinics earlier this year, following the regulatory approval from the US Food and Drug Administration (FDA).
The system supports its goal of advancing therapies for spinal cord injuries, said ONWARD Medical.
In addition, the company is also progressing with its ARC-IM implantable system, which aims to address additional needs such as blood pressure regulation.
The ARC-IM system integrates artificial intelligence (AI) and brain-computer interfaces (BCI) for enhanced functionality.
