ONWARD Medical Announces First Commercial Sales of ARC-EX System

Company Overview - ONWARD Medical is a medical technology company focused on developing therapies to restore movement, function, and independence in individuals with spinal cord injury (SCI) and other movement disabilities [8] - The company has developed ARC Therapy, which has received ten Breakthrough Device Designations from the FDA [9] - ONWARD Medical is headquartered in the Netherlands, with a Science and Engineering Center in Switzerland and a US office in Boston, Massachusetts [10] Product Development and Milestones - The ARC-EX System, the first and only FDA-approved technology to improve hand strength and sensation in people with chronic spinal cord injury, achieved its first commercial sales in the US in late December 2024 [1][2] - The ARC-EX System was granted de novo classification by the FDA on December 19, 2024, and was named a 2024 TIME Magazine Best Invention [2] - The company anticipates authorization for home use of the ARC-EX System in 2025 and plans to seek CE Mark certification in early 2025, with a commercial launch in Europe expected in the second half of 2025 [5] - ONWARD Medical is also developing an implantable system called ARC-IM and an investigational ARC-BCI System, which uses a brain-computer interface powered by AI [5][9] Market and Industry Context - Spinal cord injury affects approximately seven million people worldwide, including over 300,000 in the US, with half of the injuries resulting in tetraplegia [7] - Lifetime treatment costs for tetraplegia exceed $5 million, highlighting the significant economic impact of SCI [7] - Historically, SCI has been considered permanent with limited options for functional recovery, particularly for those more than one-year post-injury [7] Commercialization and Partnerships - UW Medicine and Next Steps Chicago were among the first to purchase the ARC-EX System, aligning with the company's goal to provide access to this technology in both community rehabilitation clinics and major academic research centers [1][4] - The ARC-EX System is currently authorized for clinic use in the US, with plans to expand its availability for home use [5] - ONWARD Medical's partnerships with institutions like UW Medicine and Next Steps Chicago aim to redefine recovery and provide innovative care for individuals with SCI [4][5]