ONWARD Medical Files 510(k) with US FDA for ARC-EX System Home Use and Submits CE Mark Application

Core Insights - ONWARD Medical N.V. has submitted two significant regulatory applications for its ARC-EX System, including a 510(k) application to the FDA for home use and a CE Mark application for commercialization in the EU [1][7] - The ARC-EX System is the first FDA-cleared technology aimed at improving hand sensation and strength after spinal cord injury (SCI), with strong early demand and positive user feedback indicating a successful market trajectory [2][4] - The company aims to expand access to the ARC-EX System, enhancing its market presence and providing improved convenience for individuals with SCI [4] Regulatory Developments - The 510(k) application seeks to allow marketing of the ARC-EX System for home use in the United States, which would significantly broaden access to the technology [7] - The CE Mark application is intended to enable commercialization of the ARC-EX System in the European Union and other countries that recognize CE Marking [3][7] Clinical Evidence - Positive results from the Pathfinder2 Study indicate that ARC-EX Therapy, combined with activity-based rehabilitation, leads to significant functional improvements in individuals with SCI, including gains in upper body strength, trunk control, and balance over a one-year period [4] Company Background - ONWARD Medical is a leading neurotechnology company focused on therapies to restore movement and function in individuals with spinal cord injuries and other movement disabilities, with a history of scientific discovery and clinical studies [5] - The company has developed ARC Therapy, which has received ten Breakthrough Device Designations from the FDA, and is also working on an investigational implantable system called ARC-IM [5] Market Position - The company is headquartered in the Netherlands, with additional facilities in Switzerland and the United States, and is publicly listed on Euronext and OTCQX [6]