FDA De Novo Application for ONWARD Medical SCI Device

Image credit: ONWARD Medical

Medtech ONWARD Medical has this month confirmed the next step for its neurostimulation ARC-EX System, with a De Novo application to the US Food and Drug Administration (FDA).

FDA clearance would enable the marketing of ARC-EX as the first-ever spinal cord stimulation therapy to restore hand and arm function after spinal cord injury.

A large-scale pivotal study conducted by ONWARD across four countries supported the safety and effectiveness of ARC-EX therapy, with 72 percent of the 65 study participants noting improvement in both strength and function of their upper limbs.

“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.”

For further information, refer to the press statement via ONWARD Medical.