Results from the investigator-sponsored Pathfinder 2 study, published in Neuromodulation: Technology at Neural Interface, detailed findings from one year of evaluations for people utilizing ARC-EX therapy. It showed that ARC-EX, combined with activity-based rehabilitation, delivered functional improvements when administered to people with spinal cord injury (SCI) in community-based rehabilitation centers.
ARC-EX SCS therapy delivers targeted, programmed electrical stimulation transcutaneously to the spinal cord. The technology uses electrodes placed on the back of the neck for non-invasive therapy without the need for surgery. It enables increased strength, movement and function in the upper limbs after SCI.
Eindhoven, The Netherlands–based Onward won FDA approval for the system in December 2024. It announced last month that it made the first commercial sales of ARC-EX in the U.S.
Onward’s FDA nod covers the use of ARC-EX in clinics and the company anticipates home use authorization in mid-2025. It also plans to seek CE mark in Europe, anticipating that regulatory nod in the second half of 2025. The company has a pipeline of technologies, including its implantable ARC-IM SCS system. It also has an investigational platform that uses a brain-computer interface (BCI) powered by AI.
More about the study results from Onward
UK-based Spinal Research sponsored the study and Neurokinex independently conducted it across its network of rehabilitation centers. It enrolled 10 participants with chronic cervical or thoracic SCI.
“The Pathfinder2 results published today in Neuromodulation demonstrate people with SCI can make continued gains with sustained access to ARC-EX therapy,” said Dave Marver, Onward CEO. “Congratulations to the team at Neurokinex for showing ARC-EX therapy can help people with SCI drive functional recovery without plateau during a one-year treatment period.”
Participants experienced gains in upper body strength, trunk control and balance. They did so without any indication of a plateau in therapeutic benefit after one year of treatment. Some participants also improved lower body movement and enhanced hand and arm strength, especially in grip and dexterity.
Additionally, three patients improved their American Spinal Injury Association Impairment Scale (AIS) classification. Four demonstrated changes in their neurological level on injury. One even moved from complete to incomplete SCI. Onward said this suggests further potentially achievable gains with extended treatment.
“This peer-reviewed publication validates that Onward ARC-EX therapy combined with activity-based rehabilitation can be safely and effectively delivered in community settings,” said Jenny Suggitt, lead investigator of Pathfinder2. “Most importantly, participants continued to show improvements throughout 120 treatment sessions over a one-year period, suggesting there is potential for further recovery with extended treatment.”
