Onward Medical has secured a CE mark in Europe for ARC-EX, a system to support the restoration of movement and function in individuals with spinal cord injury (SCI).
Secured under the European Union’s Medical Device Regulation (EU MDR), ARC-EX delivers electrical spinal cord stimulation (SCS) for SCI via electrodes attached to the neck, presenting a non-invasive option.
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The Netherlands-headquartered company’s ARC-EX is the first SCI-approved device in Europe that is specifically indicated for improving hand strength and sensation in adults with SCI and is promoted for use in conjunction with standard rehabilitation practices. It joins other SCIs on the European market, including Aneuvo’s ExaStim, which is indicated for restoring motor function in individuals with chronic SCI.
According to the World Health Organization (WHO), SCI affects around seven million people worldwide, with an estimated 300,000 in the US.
Onward said a phased roll-out of ARC-EX in Europe will be initiated in the coming weeks, starting with Germany, with other countries to follow “as soon as possible” thereafter.
Onward’s CEO Dave Marner commented: “Hand sensation and strength is a primary recovery target after SCI. The ARC-EX Therapy opens new doors for the SCI community in Europe, offering opportunities for recovery and care that were previously unavailable.”
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By GlobalDataEuropean approval for ARC-EX follows Onward’s receipt of de novo classification for the system from the US Food and Drug Administration (FDA) in December 2024.
Both approvals were supported by Onward’s pivotal Up-LIFT (NCT04697472) trial, in which the system met its primary and secondary endpoints in May 2024. Published in Nature Medicine, the trial results demonstrated that 90% of patients who used the treatment improved strength or function, with 87% reporting quality of life (QoL) improvement.
Other study findings included reports of less spasm frequency, improved sleep quality, and improved upper body sensation and sense of touch. Onward also highlighted that benefits were observed in patients with injuries incurred up to 34 years ago.
According to a report by GlobalData, Onward has nine other neurology devices in active stages of development, including ARC-IM, an implantable system designed to address several unmet needs, including blood pressure instability after spinal cord injury.
