ONWARD Medical Receives FDA 510(k) Clearance Expanding ARC-EX System Indication for Home Use

Core Insights - ONWARD Medical N.V. has received FDA 510(k) clearance to expand the ARC-EX System for home use, significantly enhancing market opportunities for spinal cord injury (SCI) therapies [2][4][6] - The ARC-EX System is designed to improve hand strength and sensation in adults with chronic, non-progressive neurological deficits due to incomplete SCI, and can be used both in clinics and at home [3][11] Company Overview - ONWARD Medical is a leading neurotechnology company focused on developing therapies to restore movement and independence for individuals with spinal cord injuries and other movement disabilities [7][8] - The company has received 10 Breakthrough Device Designations from the FDA and is also developing an investigational implantable system called ARC-IM [7] Product Details - The ARC-EX System utilizes non-invasive, programmed transcutaneous electrical spinal cord stimulation and is intended for use by rehabilitation professionals in medical centers and by patients at home [3][11] - Clinical studies supporting ARC-EX Therapy show that 90% of participants improved strength or function, and 87% reported enhanced quality of life, with benefits observed up to 34 years post-injury [4][5] Market Impact - The FDA clearance for home use of the ARC-EX System is expected to broaden access to innovative therapies for individuals with SCI, potentially improving their quality of life [4][6] - The system is currently available in over 60 clinics across the US and has been recognized as one of TIME magazine's Best Inventions [5][6]