Onward Medical announced today that it has commenced the inaugural sales of its ARC-EX spinal cord stimulation system in the U.S. This milestone sale follows less than a month after the Eindhoven-based company secured FDA clearance for the system.
The innovative ARC-EX SCS therapy administers planned electrical stimulation directly to the spinal cord through non-invasive means. It involves placing electrodes externally on the neck, without requiring surgical intervention. This revolutionizes the enhancement of strength, movement, and functionality in upper limbs post spinal cord injury (SCI).
The Up-LIFT study validated the safety and efficacy of ARC-EX, achieving all key benchmarks. It demonstrated notable enhancements in strength, functionality, and the sensation of the upper limbs. The research targeted subjects with persistent tetraplegia resulting from cervical spinal cord injury.
Onward’s FDA approval permits ARC-EX’s use within clinical settings, and the company predicts authorization for home use by mid-2025. They also aim to secure the CE mark in Europe, expecting this by late 2025. Onward continues to innovate, with developments like the implantable ARC-IM SCS system and a brain-computer interface platform utilizing AI.
Sales were made to the University of Washington School of Medicine and Next Steps Chicago.
“The first commercial sales of our ARC-EX System are a transformational step in our journey to aid individuals with spinal injuries, illustrating our capacity to convert scientific advancements into tangible benefits,” said Dave Marver, CEO of Onward Medical.