The Eindhoven, the Netherlands-based company designed ARC-EX to restore function of upper extremities after spinal cord injury (SCI). If approved, the company says ARC-EX would become the first ever SCS therapy that restores hand and arm function after SCI. It would also become the first commercial product for Onward. The company also has its investigational ARC-IM system for improved blood pressure regulation after spinal cord injury and the ARC-BCI system that won FDA breakthrough device designation in February.
According to a news release, Onward prioritized upper limb function as its first indication for the ARC-EX system. The company said last month that it raised nearly $22 million with a large chunk of those funds earmarked for a potential ARC-EX launch.
Onward ARC-EX therapy delivers targeted, programmed electrical stimulation transcutaneously to the spinal cord. It enables increased strength, movement and function in the upper limbs after SCI. The company supported its de novo application with data from its Up-LIFT large-scale pivotal study. Results showed that, out of 65 participants with chronic tetraplegia at 14 leading SCI neurorehabilitation centers in the United States, Canada, the United Kingdom, and the Netherlands, ARC-EX met all primary safety and effectiveness endpoints. It demonstrated a 72% response rate to ARC-EX therapy as well.
“We are delighted to be one step closer to bringing our breakthrough ARC-EX system to people living with SCI after submitting this de novo application for regulatory clearance in the United States,” said Onward Medical CEO Dave Marver. “This therapy has the potential to transform the lives of people living with paralysis, while also positively impacting their loved ones.”
