THIS PRESS RELEASE CONTAINS INSIDE INFORMATION WITHIN THE MEANING OF ARTICLE (7)(1) OF THE EUROPEAN MARKET ABUSE REGULATION (596/2014) ARC-EX System is the first and only FDA approved technology shown to improve hand strength and sensation after chronic spinal cord injury ARC-EX System is an FDA Breakthrough Device and 2024 TIME Magazine Best Invention EINDHOVEN, the Netherlands, Dec. 19, 2024 (GLOBE NEWSWIRE) -- 5:45pm December 19, 2024 -- 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 .