People with spinal cord injuries will soon have a new treatment option to improve neurological function and sensation. On Dec. 19, ONWARD Medical announced that it received FDA authorization to market its ARC-EX transcutaneous stimulation device — making it the first transcutaneous stimulation system available for clinical use in the United States.

With a small control box and two electrodes that stick to your skin, transcutaneous stimulation devices like the ARC-EX resemble functional electrical stimulation devices that people use to activate weak or paralyzed muscles. But unlike FES units, transcutaneous stimulation devices send the current directly to the spinal cord to excite weak or dormant communication pathways. Research has shown transcutaneous stimulation is able to improve function in people with chronic SCI and those with more complete injuries.

Now the ARC-EX device, and likely others soon, will start making their way to clinics and SCI rehab centers. ONWARD says it anticipates approval for home use in 2025.

“For the first time, there is an approved therapy shown to improve hand strength and sensation after chronic SCI,” said Dave Marver, CEO of ONWARD Medical. “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.”

The FDA approval for the ARC-EX device was based in part on research conducted by Dr. Chet Moritz at the University of Washington to help improve hand function in people with cervical-level SCI. Kate Willette described the results of the research in a 2018 New Mobility article:

“Finger dexterity also improved. Some could pinch a debit card and get it into an ATM, use a cell phone or turn a key in a lock. One of them was able to twist the cap off a water bottle. Their average maximum grip strength had more than tripled by the end of the study, but also — just as in the epistim trials — they enjoyed improvements in other quality of life measures. Sensation was better. Trunk control was more reliable. They even made gains in bowel and bladder control.”

The research was exciting when it came out — certainly not a cure, but a chance for real functional return. Now that same technology has a path to widespread use. 

“This approval represents a watershed moment for the SCI community,” says Maggie Goldberg, president and CEO of the Christopher & Dana Reeve Foundation. “For those living with SCI and paralysis, the wait for even a single therapy to enhance their health and quality of life has been long and arduous. Now, we believe this milestone signals the opening of the floodgates for future advancements.”

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