Treating spinal cord injuries involves highly complex and intensive rehabilitation, historically limited to specialized medical facilities. This may soon change thanks to the Dutch-American company ONWARD Medical.
Their ARC-EX system, a non-invasive device using transcutaneous electrical spinal cord stimulation, has now been cleared for use outside clinical settings, allowing patients to use it at home under supervision or with the help of caregivers.
The company reports that within less than a year, the device has already been introduced in over 60 clinics across the U.S. The Up-LIFT study, published in journals including Nature Medicine, showed improvements in hand strength or sensation in 90% of participants and enhanced quality of life in 87% of patients. ONWARD also noted that the system was commercially launched in December 2024, with revenues for the first half of 2025 reaching approximately €1.2 million, up from €0.2 million the previous year — driven primarily by the sale of 30 ARC-EX units in the U.S.
FDA’s decision has a significant impact for individuals with incomplete spinal cord injuries, who often face logistical challenges accessing in-clinic therapies due to limited mobility. Home-based therapy fundamentally changes the approach to neurological rehabilitation. ONWARD emphasized that ARC-EX is the first technology worldwide to offer such approval — non-invasive and intended for home use in this patient group.
From a commercial perspective, FDA’s expanded clearance could accelerate the adoption of ARC-EX in the home spinal cord injury therapy market, potentially influencing ONWARD Medical’s business model. However, the company is still not profitable — despite increased sales and revenue growth, it continues to operate at a loss, though it currently holds more cash than liabilities according to market analysis. Rapid adoption of such solutions by “regular” users could improve the company’s financial standing.