FDA clears ARC-EX, Onward Medical’s non-invasive spinal cord stimulation system

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ARC-EX is the first FDA-approved technology shown to improve hand strength and sensation patients more than one year post-injury.

ARC-EX 

Credit: Onward Medical

ARC-EX

Credit: Onward Medical

Onward Medical has received de novo classification and market authorization from the U.S. Food and Drug Administration (FDA) for its ARC-EX System, a non-invasive spinal cord stimulation device designed to improve hand strength and sensation in people with chronic spinal cord injury (SCI).

It is the first FDA-approved technology shown to enhance these functions in patients more than one year post-injury.

“With today’s FDA de novo classification and authorization to market the ARC-EX System in the US, a new era begins for people with chronic spinal cord injury,” said Dave Marver, CEO of Onward Medical, in a news release. “For the first time, there is an approved therapy shown to improve hand strength and sensation after chronic SCI. 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 ARC-EX System delivers electrical stimulation through electrodes placed on the back of the neck and does not require surgical implantation. Results from the Up-LIFT clinical study, published in Nature Medicine (2024), showed that 90% of participants experienced improved strength or function, while 87% reported enhanced quality of life. Benefits were observed up to 34 years post-injury and included decreased spasm frequency, better sleep, and improved upper body sensation.

Spinal cord injuries impact about seven million individuals worldwide, including more than 300,000 in the United States. Half of these injuries result in tetraplegia, affecting the function of all four limbs. Beyond immediate loss of motor and sensory function, secondary complications can include incontinence, compromised blood pressure regulation, and diminished sexual function. Treatment costs for tetraplegia can exceed $5 million, underscoring the need for innovative, cost-effective interventions.

“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 ARC-EX 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.”

Onward expects to begin offering the ARC-EX System for clinical use in the United States immediately. Home-use authorization is anticipated in mid-2025. The company plans to seek CE Mark certification for commercialization in Europe in early 2025, with authorization expected in the second half of that year. The ARC-EX System was named a TIME Magazine Best Invention in 2024.

Onward is also developing an implantable ARC-IM System and the ARC-BCI System, which integrates a brain-computer interface powered by artificial intelligence.

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