ARC-IM is ONWARD Medical's investigational implantable spinal cord stimulation system designed to restore function in people with spinal cord injury. The system consists of an implanted neurostimulator/pulse generator (IPG), epidural leads designed specifically for SCI, an external hub for communication and charging, a tablet programmer, and a smartphone patient app. ARC-IM has received four FDA Breakthrough Device Designations: for leg motor function (2020), blood pressure normalization and trunk stability (2021), bladder control (2022), and spasticity reduction (2023). The STIMO study demonstrated the ability to enable long-paralyzed individuals to stand and walk with minimal assistance. ONWARD is also pairing BCI technology with ARC-IM for more natural movement restoration.
FDA Breakthrough Device Designation provides more interactive communication with FDA during development and a priority review pathway. The device is still under investigation and not yet approved for commercial sale.
FDA Device Regulatory Guidance ↗