FDA clearance would allow the company to market its breakthrough therapy to improve or restore hand and arm function after spinal cord injury in the United States.
EINDHOVEN, Netherlands – April 4, 2024 – ONWARD® Medical NV (Euronext: ONWD), a medical technology company creating innovative therapies aimed at restoring movement, independence and health to people with spinal cord injuries ( LME), announces that it has submitted an application to the United States Food and Drug Administration (FDA) for marketing authorization for its revolutionary ARC-EX system intended to restore upper limb function after injury medullary.
This authorization request marks a historic step for the company which plans to market the ARC-EX system in the United States at the end of 2024. Once the FDA has validated its marketing, ARC-EX will be the very first therapy of spinal cord stimulation aimed at restoring hand and arm function after spinal cord injury and the first product marketed by ONWARD Medical.
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