Onward Medical revealed the publication of positive results from the investigator-sponsored Pathfinder2 study of its ARC-EX therapy.

The paper details findings from a one-year trial showing that ARC-EX combined with activity-based rehabilitation delivered “significant function improvements” when given to people with spinal cord injury (SCI) in community-based rehab centers. The study was sponsored by UK-based Spinal Research, and independently conducted by Neurokinex at its network of community-based rehabilitation centers.

It enrolled ten subjects with chronic cervical or thoracic SCI. Onward said patients achieved gains in upper body strength, trunk control, and balance, without indication of plateau in therapeutic benefit after a year of treatment. Some participants also improved lower body movement and better hand/arm strength—particularly in grip and dexterity, Onward reported.

Three participants improved their American Spinal Injury Association Impairment Scale (AIS) classification, and four showed changes in neurological level of injury, including a participant who moved from complete to incomplete SCI.

The ARC-EX system was approved by the FDA for use in clinical settings in December 2024. Onward said it aims to achieve CE mark certification for ARC-EX in 2025.

“The Pathfinder2 results published in Neuromodulation demonstrate people with SCI can make continued gains with sustained access to ARC-EX Therapy,” said Dave Marver, CEO of Onward Medical. “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.”

The company is also developing its investigational, implantable ARC-IM system and ARC-BCI system, which uses a brain-computer interface (BCI) powered by artificial intelligence (AI).

“I’m hugely encouraged by the positive outcomes of the Pathfinder2 study and believe ARC-EX Therapy will enable us to deliver even greater gains for people living with a spinal cord injury,” said Harvey Sihota, founder and CEO of Neurokinex. “There is no doubt that spinal stimulation technologies will take spinal cord injury rehab and outcomes to the next level bringing even more meaningful functional improvements that offer people greater independence.”