ONWARD Medical Receives FDA De Novo Classification and US Market Authorization for World's First Non-Invasive Spinal Cord Stimulation System for People with Chronic Spinal Cord Injury

Core Insights - ONWARD Medical N.V. has received FDA de novo classification and authorization to market its ARC-EX System, the first FDA-approved technology to improve hand strength and sensation after chronic spinal cord injury (SCI) [1][2] - The ARC-EX System is recognized as a Breakthrough Device and was named one of TIME Magazine's Best Inventions of 2024 [1][7] - The device utilizes non-invasive electrical stimulation to enhance spinal cord function, marking a significant advancement in therapies for individuals with chronic SCI [2][7] Company Overview - ONWARD Medical is focused on developing innovative therapies aimed at restoring movement and independence for individuals with spinal cord injuries and other movement disabilities [8] - The company has a pipeline of technologies, including the investigational ARC-IM System and ARC-BCI System, which incorporates brain-computer interface technology [3][8] - The company is headquartered in the Netherlands and has additional facilities in Switzerland and the United States [9] Clinical Impact - The Up-LIFT clinical study demonstrated that 90% of participants improved in strength or function, and 87% reported enhanced quality of life, with benefits observed up to 34 years post-injury [3][6] - Regaining hand function is prioritized significantly higher than other abilities lost due to paralysis, indicating a strong demand for effective therapies in this area [3] Market Authorization and Future Plans - The current FDA authorization is for clinical use, with home use expected to be authorized by mid-2025 [3] - The company plans to seek CE Mark certification for the ARC-EX System in Europe, with expectations for authorization in the second half of 2025 [3]