A Historic Leap Forward: FDA Approves First SCI-Specific Therapy

The Christopher & Dana Reeve Foundation is thrilled to celebrate a groundbreaking milestone in SCI treatment announced by our industry partner, ONWARD Medical: the first-ever FDA-approved technology designed specifically for the SCI community. The ARC^EX® System, the world’s first non-invasive spinal cord stimulation therapy, has demonstrated significant improvements in hand strength and sensation for individuals living with SCI.

Named one of TIME Magazine’s Best Inventions of 2024, the ARC^EX® System has already shown transformative potential. Clinical trials revealed that participants regained critical abilities that are essential to daily independence. This FDA market authorization allows the ARC^EX® System to be used in clinical settings, with home-use authorization anticipated later.

A Breakthrough Rooted in Science

The FDA approval of the ARC^EX® follows ONWARD Medical’s pivotal global clinical trial, published in Nature Medicine. The results were astounding: 90% of participants experienced improved strength or function, 87% reported enhanced quality of life, and benefits were observed up to 34 years post-injury. The trial included 65 participants across 14 of the world’s leading rehabilitation centers.

“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 and a member of the Foundation’s Scientific Advisory Board. “I believe the ARC^EX® System will have a tremendous impact on the quality of life of people living with SCI.”

Clinicians across the US are excited to have access to this breakthrough technology, to give patients an opportunity to dramatically improve their lives.

Driving Impact Through Partnerships

Two decades ago, the Christopher & Dana Reeve Foundation identified neurostimulation as one of the most promising areas of research. By targeting the spinal cord with electrical stimulation, researchers believed they could help restore lost function, including movement, bladder control, blood pressure regulation, and more.

Our longstanding partnership with ONWARD Medical, bolstered by grants to .NeuroRestore and investments through SCI Ventures, exemplifies the power of collaboration between nonprofits, academia, and industry in driving innovation.

This revolutionary approval is a testament to the vision, dedication, and persistence of countless researchers, clinicians, advocates, and supporters. “No longer will people be sent home and told nothing can be done to help them regain these abilities after their injury,” said ONWARD Medical CEO Dave Marver. “We hope this is the first of many therapies we will introduce to help people regain independence from paralysis and other movement disabilities.”

Pioneering the Future of SCI Recovery

The road to this achievement has been paved with bold vision, unwavering determination, and an unrelenting belief in the power of science. The Reeve Foundation’s steadfast supporters have been instrumental in making this moment possible -- and this FDA approval is a shared victory.

But this is just the beginning. With breakthroughs like the ARC^EX® System, we are on the cusp of transforming lives in ways once thought impossible. Together, we are proving that SCI does not have to mean a lifetime of paralysis, and paralysis does not have to mean a diminished quality of life.

Learn more and stay updated by visiting ONWARD Medical’s official site to register for news and information on rehabilitation centers where the ARC^EX® System will soon be available.