The US Food and Drug Administration (FDA) has granted de novo classification to Onward Medical for its ARC-EX system in patients with spinal cord injury (SCI).
The approval marks the first non-invasive spinal cord stimulator to reach market in the US for SCI patients. The current market authorisation is for the device’s use in clinics, with Onward forecasting an extension to include home use in mid-2025. The Netherlands-headquartered company plans to pursue European approval in 2025 too.
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Shares in Brussels-listed Onward opened 7% higher at market open on 20 December. The company has a market cap of $220.1m (€211.85m).
A range of spinal cord stimulators have been approved by the FDA, but none specifically for SCI patients. Abbott, Medtronic and Boston Scientific all have products indicated for chronic pain.
According to the World Health Organisation, SCI affects approximately seven million people worldwide, with an estimated 300,000 in the US.
A market model by GlobalData forecasts the global neuromodulation device market will be worth $11.4bn by 2033, up from $6bn in 2022.
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By GlobalDataOnward’s ARC-EX delivers targeted, programmed spinal cord stimulation non-invasively, rather than via implanted electrodes. This means the technology does not need surgery to be administered, unlike other spinal cord stimulation devices. It is the non-implantable counterpart of the ARC-IM, although both devices work via stimulation of the spinal cord.
ARC-EX met its primary and secondary endpoints in a trial called Up-LIFT (NCT04697472) in May 2024. Results from the trial, which were published in Nature Medicine, demonstrated that 90% of participants using the treatment improved strength or function and 87% reported improvement in quality of life. The study reported less spasm frequency, improved sleep quality, and improved upper body sensation and sense of touch. Onward added that benefits were observed in patients with injuries incurred up to 34 years ago.
Jessie Owe, who used the device in a pilot study, previously said in a patient testimonial: “I found myself being able to open some jars. I found myself being able to use some scissors and then I felt confident enough to try a knife… I found myself being able to write a little bit more slowly, but I could do it.”
Maggie Goldberg, CEO of the SCI charity the Christopher and Dana Reeve Foundation, said the approval is a “watershed moment”.
“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,” she said.
Along with ARC-EX and ARC-IM, Onward’s pipeline includes ARC-BCI, a system coupled with a brain chip. ARC-BCI functions by receiving commands from an implanted brain-computer interface in the patient and is currently being evaluated in an early feasibility study. Onward raised $54m in October to advance its clinical devices and help with the commercial launch of ARC-EX.
