ONWARD Medical Announces Publication of One-Year Study Showing Benefit of Sustained Access to ARC-EX Therapy
February 25, 2025 – Biotechnology, Clinical Trials, Other – ARC-EX therapy, MedTech, ONWARD Medical, clinical trials, spinal cord injury, spinal cord stimulation
- Study shows significant functional improvements after one year of ARC-EX Therapy
- Improvements were observed throughout one-year treatment period with no plateau
- Results demonstrate the importance of sustained access to ARC-EX Therapy.
25 February 2025 — Eindhoven, the Netherlands — ONWARD Medical N.V., the medical technology company creating innovative spinal cord stimulation therapies to restore movement, function, and independence in people with spinal cord injury (SCI) and other movement disabilities, today announces the publication of positive results from the investigator-sponsored Pathfinder2 Study in Neuromodulation: Technology at Neural Interface.
The peer-reviewed paper details findings from a one-year trial demonstrating that ONWARD ARC-EX Therapy combined with activity-based rehabilitation delivered significant functional improvements when administered to people with SCI in community-based rehabilitation centers.
“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, CEO 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 study, sponsored by UK-based Spinal Research, and independently conducted by Neurokinex at its network of community-based rehabilitation centers, enrolled 10 participants with chronic cervical or thoracic SCI. Participants experienced gains in upper body strength, trunk control, and balance, without any indication of 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.*
“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 Spinal Research. “This breakthrough device demonstrates that function can be restored. With proper investment in spinal cord research, we can accelerate progress toward meaningful treatments for paralysis. The science shows promise – what we need now is the funding to advance this critical work.”
Additionally, 3 participants improved their American Spinal Injury Association Impairment Scale (AIS) classification, and 4 demonstrated changes in their neurological level of injury, including a participant who moved from complete to incomplete SCI. These findings reinforce the long-term benefits of continued access to ARC-EX Therapy and suggest further gains may be achievable 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, MSc, OTR/L, 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.”
“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.”
In December 2024, the ONWARD ARC-EX System® was approved by the US FDA for use in clinic settings. Home use authorization is anticipated later this year. The Company plans to seek CE Mark certification to commercialize the ARC-EX System in Europe in 2025.
ONWARD Medical is developing a pipeline of technologies, including its investigational implantable ARC-IM System and its investigational ARC-BCI System, an implanted platform that uses a brain-computer interface (BCI) powered by artificial intelligence (AI). To learn more about ONWARD Medical’s commitment to partnering with the SCI Community to develop innovative solutions for restoring movement, function, and independence after spinal cord injury, please visit ONWD.com.
To be kept informed about the Company’s technologies, research studies, and the availability of therapies in your area, please complete this webform.
About ONWARD Medical
ONWARD Medical is a medical technology company creating therapies to restore movement, function, and independence in people with SCI and other movement disabilities. Building on more than a decade of scientific discovery, preclinical research, and clinical studies conducted at leading hospitals, rehabilitation clinics, and neuroscience laboratories, the Company has developed ARC Therapy, which has been awarded ten Breakthrough Device Designations from the US Food and Drug Administration (FDA). In addition to the ARC-EX System, which is now cleared for commercial sale in the US, the Company is developing an implantable system called ARC-IM with and without an implanted brain-computer interface (BCI).
Headquartered in the Netherlands, the Company has a Science and Engineering Center in Switzerland and a US office in Boston, Massachusetts. The Company is listed on Euronext Paris, Brussels, and Amsterdam (ticker: ONWD). For more information, visit ONWD.com
