11/28/2025
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We are pleased to announce that we have received clearance to expand the ARC-EX System indication for home use in the US. The Food and Drug Administration has cleared the ARC-EX System for use in conjunction with functional task practice in the clinic and take-home exercises in the home to improve hand strength and sensation in adults with spinal cord injury.
“For people with limited mobility who navigate daily logistical challenges, having the option to use this therapy at home can make a meaningful difference. Integrating in-clinic and at-home therapy may help support and maintain improvements in hand strength and sensation, contributing positively to overall quality of life,” said Dr. Candy Tefertiller, PT, DPT, PhD, NCS, Executive Director of Research and Evaluation at Craig Hospital in Denver, Colorado.
“For more than 40 years, the Christopher & Dana Reeve Foundation and our community have invested boldly in high-risk, high-reward science, pairing funding and leadership with the lived experience of those living with and those who care for them. Today’s achievement demonstrates that we are now seeing breakthroughs once thought impossible,” said Marco Baptista, Ph.D., Chief Scientific Officer of the Christopher & Dana Reeve Foundation.
The ARC-EX System is non-invasive and delivers programmed, transcutaneous electrical spinal cord stimulation. It is intended to be operated in medical centers by rehabilitation professionals and at home by patients and persons providing assistance to patients, as needed.
ARC-EX 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, nonprogressive neurological deficits 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 patients, as needed.
