Onward Medical has received de novo classification and authorization to market its ARC-EX system from the U.S. Food and Drug Administration (FDA).

ARC-EX provides programmed electrical stimulation through the skin to the spinal cord using electrodes placed on the back of the neck. The device is non-invasive and doesn’t need surgery, unlike other spinal cord stimulation devices.

The FDA’s market authorization is for use of ARC-EX in clinics. Authorization for home use is expected in mid-2025, according to Onward. The company plans to seek CE mark clearance for European commercialization in early 2025, with authorization anticipated in H2 2025.

Onward is creating a pipeline of technologies, including its investigational, implantable ARC-IM system and investigational ARC-BCI system, an implanted platform that uses a brain-computer interface (BCI) powered by artificial intelligence (AI).

“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. 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.”

Results of the Up-LIFT clinical study published in Nature Medicine showed that 90% of study participants improved strength or function, 87% reported improvement in quality of life, and benefits were observed up to 34 years post-injury. The study also reported less spasm frequency, improved sleep quality, and improved upper body sensation and sense of touch.

“This approval represents a watershed moment for the SCI Community. 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,” said Maggie Goldberg, president and CEO of the Christopher & Dana Reeve Foundation. “The Reeve Foundation, along with our donors and supporters, has been steadfast in our commitment to this cause. Nearly 20 years ago, we recognized epidural stimulation as one of the most promising avenues in SCI research. Today, this historic approval affirms our belief that it is the beginning of more to come.”