For Journalists

The ONWARD^® Medical ARC^EX® System is FDA cleared for use in the United States and CE marked in accordance with EU Medical Device Regulation 2017/745. ONWARD ARC^IM® and ARC^BCI™, alone or in combination with a brain-computer interface (BCI), are investigational and not available for commercial use.

Indication for Use (US): The ARC^EX® System is intended to deliver programmed transcutaneous electrical spinal cord stimulation in conjunction with functional task practice in the clinic and with take-home exercises in the home to improve hand sensation and strength in individuals between 18 and 75 years old that present with a chronic, non-progressive neurological deficit resulting from an incomplete spinal cord injury (C2-C8 inclusive). The ARC-EX System is intended to be operated in medical centers by Rehabilitation Professionals and at home by Patients and Persons Providing Assistance to the Patient as needed.

Indication for Use (EU): The ARC^EX® System is intended to deliver programmed, transcutaneous electrical spinal cord stimulation in conjunction with functional task practice in the clinic and with take-home exercises in the home to improve hand sensation and strength in individuals between 18 and 75 years old that present with a chronic, non-progressive neurological deficit resulting from an incomplete spinal cord injury (C2-C8 inclusive).