Onward Medical received FDA de novo clearance for its ARC-EX spinal cord stimulation (SCS) system. ARC-EX SCS therapy delivers targeted, programmed electrical stimulation transcutaneously to the spinal cord. The technology uses electrodes placed on the back of the neck for non-invasive therapy without the need for surgery. It enables increased strength, movement and function in the upper limbs after SCI. The company submitted ARC-EX to the FDA for approval in April.
Results from the company’s Up-LIFT study showed that ARC-EX achieved all primary safety and effectiveness endpoints. Additionally, ARC-EX showed significant improvements in upper limb strength, function and sensation. That study looked at subjects with chronic tetraplegia due to cervical spinal cord injury (SCI).
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Onward said FDA clearance covers the use of ARC-EX in clinics and it anticipates home use authorization in mid-2025. It also plans to seek CE mark in Europe, anticipating that regulatory nod in the second half of 2025. The company has a pipeline of technologies, including its implantable ARC-IM SCS system. It also has an investigational platform that uses a brain-computer interface (BCI) powered by 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,” said Dave Marver, CEO of Onward Medical. “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.”
