ONWARD Medical N.V. (Euronext: ONWD), the medical technology company creating innovative therapies to restore movement, function, and independence in people with spinal cord injury (SCI), today announced that it has received de novo classification and authorization to market its ARC-EX System from the US Food and Drug Administration (FDA).
“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.”
The ARC-EX System delivers programmed electrical stimulation through the skin to the spinal cord via electrodes placed on the back of the neck. The device is non-invasive and does not require surgery like other spinal cord stimulation devices.
“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.”
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.1
“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,” says Maggie Goldberg, President & 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.”
Today’s FDA market authorization is for use of the ARC-EX System in clinics; home use authorization is anticipated in mid-2025. The Company plans to seek CE Mark certification to commercialize the ARC-EX System in Europe in early 2025, with authorization expected 2H 2025. The Company is developing a pipeline of technologies, including its investigational implantable ARC-IM System and its investigational ARC-BCI System, an implanted platform that uses a brain-computer interface (BCI) powered by artificial intelligence (AI).
