FDA grants De Novo authorization to ONWARD's ARC-EX spinal cord stimulation system

ONWARD Medical/ARC Therapy (ARC-EX / ARC-IM / ARC-BCI)

The FDA granted De Novo authorization (the pathway for novel devices with no predecessor) to ONWARD Medical's ARC-EX, which applies targeted stimulation to the spinal cord through the skin to aid rehabilitation after cervical spinal cord injury. In the Up-LIFT pivotal trial of 60 participants, hand strength or sensation improved in 72% of participants, with 90% showing improvement in at least one functional metric.

• De Novo authorization indicates FDA determined ARC-EX is safe and effective for spinal cord stimulation therapy; no serious adverse events related to therapy reported.
• Up-LIFT trial: 72% of 60 participants improved beyond minimal important difference in both strength and function; 87% reported improved quality of life after average of 25 stimulation sessions.
• Non-invasive delivery via surface electrodes; complements rather than replaces physical rehabilitation; particularly effective for hand and arm function in chronic tetraplegia.