ONWARD Medical's groundbreaking spinal cord stimulation therapy has demonstrated sustained therapeutic benefits in patients with spinal cord injury (SCI) over a one-year treatment period, according to results published in Neuromodulation: Technology at Neural Interface.
The investigator-sponsored Pathfinder2 Study, conducted at Neurokinex rehabilitation centers in the UK, evaluated the combination of ONWARD's ARC-EX Therapy with activity-based rehabilitation in 10 participants with chronic cervical or thoracic SCI.
Key Clinical Outcomes
Participants experienced significant functional improvements throughout the 120-treatment session period, with no indication of reaching a therapeutic plateau. Notable gains included:
- Enhanced upper body strength
- Improved trunk control and balance
- Better hand and arm function, particularly in grip and dexterity
- Improved lower body movement in some participants
Remarkably, three participants showed improvement in their American Spinal Injury Association Impairment Scale (AIS) classification, while four demonstrated changes in their neurological level of injury. One participant progressed from complete to incomplete SCI, suggesting potential for meaningful neurological recovery with extended treatment.
Expert Perspectives
"It's now time to stop talking about spinal cord injury as being incurable and to start talking about it as improvable," said Tara Stewart, Chair of Spinal Research, the organization sponsoring the study. "This breakthrough device demonstrates that function can be restored."
Jenny Suggitt, MSc, OTR/L, Lead Investigator of Pathfinder2, emphasized the therapy's potential for continued improvement: "Participants continued to show improvements throughout 120 treatment sessions over a one-year period, suggesting there is potential for further recovery with extended treatment."
Therapeutic Implementation and Future Developments
The ARC-EX System received FDA approval for clinic settings in December 2024, marking a significant milestone in SCI treatment. ONWARD Medical plans to:
- Pursue home use authorization later this year
- Seek CE Mark certification for European commercialization in 2025
- Continue development of additional technologies, including the implantable ARC-IM System and AI-powered ARC-BCI System
"The Pathfinder2 results demonstrate people with SCI can make continued gains with sustained access to ARC-EX Therapy," noted Dave Marver, CEO of ONWARD Medical, highlighting the therapy's potential to transform SCI rehabilitation outcomes.
Clinical Implementation
The study validates that ARC-EX Therapy can be safely and effectively delivered in community-based rehabilitation settings, potentially increasing accessibility for patients requiring long-term treatment. This implementation model could prove crucial for maximizing therapeutic benefits and improving patient outcomes.
Harvey Sihota, founder and CEO of Neurokinex, expressed optimism about the therapy's future impact: "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."
