Reeve Foundation Partner, ONWARD Medical, Announces World’s First FDA-Approved Non-Invasive Spinal Cord Stimulation System for People with Chronic Spinal Cord Injury
Image Credit: Onward® Medical
Today, we celebrate a groundbreaking milestone announced by our industry partner, ONWARD Medical: the first-ever FDA-approved technology designed specifically for the spinal cord injury (SCI) community. The ARCEX® System is the world’s first non-invasive spinal cord stimulation therapy and has demonstrated improved hand strength and sensation in individuals with chronic spinal cord injuries.
Named one of TIME Magazine’s Best Inventions of 2024, the ARCEX® System has demonstrated extraordinary potential, as witnessed by the Reeve Foundation. Clinical trials have shown that participants regained critical abilities essential for daily independence.
Today’s FDA market authorization is for use of the ARCEX® System in clinics; home use authorization is anticipated in mid-2025.
“Regaining hand ability is the highest treatment priority for people with paralysis, five-fold higher than regaining all other abilities lost to injury,” said Chet Moritz, PhD, Professor of Rehabilitation Medicine at the University of Washington. “I believe the ARCEX® System will have a tremendous impact on the quality of life of people living with SCI. My clinical and research colleagues in the US are eager and excited to have access to this important breakthrough technology.”
The FDA approval follows the publication of ONWARD’s pivotal global trial results in Nature Medicine. The study demonstrated that 90% of participants experienced improved strength or function, 87% reported improvement in quality of life, and benefits were observed up to 34 years post-injury. The trial involved 65 participants across 14 of the world’s leading rehabilitation clinics.
Two decades ago, the Christopher & Dana Reeve Foundation identified neurostimulation — electrical stimulation targeting the spinal cord to restore lost function — as one of the most promising areas of research. This technology activates remaining nerve pathways, potentially improving movement, bladder control, blood pressure and more after SCI. Our enduring partnership with ONWARD — furthered by grants to .NeuroRestore, ONWARD’s research partner, and through SCI Ventures — reflects a forward-thinking collaboration between nonprofits and industry to drive innovation.
This partnership approach has led to significant breakthroughs, culminating in today’s transformative achievement for those with chronic SCI. But our work is far from done. “No longer will people be sent home and told nothing can be done to help them regain these abilities after their injury. We hope this is the first of many therapies we will introduce to help people regain independence from paralysis and other movement disabilities,” said Dave Marver, CEO of ONWARD Medical.
The journey to this historic approval has demanded unwavering dedication, bold vision, steadfast hope, unshakable faith in the power of science, relentless persistence, and extraordinary generosity. To our longtime friends and supporters who have fueled Reeve-funded research over the years, we extend our deepest gratitude. You made this moment possible, and we hope you feel the profound joy of this shared triumph.
If you’re new to Reeve research, now is the perfect time to join us. With breakthroughs like the ARCEX® System, we are on the cusp of transforming lives in ways once thought impossible. Your support today could help pave the way for the next life-changing innovation. Together, we can create a world in which spinal cord injury does not result in paralysis and paralysis does not result in diminished quality of life. Let’s keep pushing forward together — because hope demands action.
Learn more here and visit https://survey.onwd.com/support to register for regular updates and information about the rehabilitation centers where the system will become available in the coming months.
Please consider a gift as we mark this momentous year for SCI research.
Maggie Goldberg
President and CEO, Christopher & Dana Reeve Foundation
