Editor’s note: This is a follow-up to an article we published in 2022 on promising developments in the use of spinal simulation for people living with spinal cord injury.
ONWARD Medical, the medical technology company creating innovative therapies to restore movement, independence, and improve health in people with spinal cord injury, was recently granted Breakthrough Device Designation status from the U.S. Food and Drug Administration (FDA) for the use of its ARC-EX platform for bladder control, alleviation of spasticity, and blood pressure regulation in people with SCI.
ARC-EX is an external, non-invasive platform consisting of a stimulator and wireless programmer that is designed to deliver targeted, programmed spinal cord stimulation to restore movement and other functions in people with spinal cord injury. The results of ONWARD’s first study, called Up-LIFT, demonstrated the technology safely improved upper-arm strength and function in people with spinal cord injury and its potential for treating other nervous system disorders.
ONWARD is now preparing regulatory submissions for the U.S. and Europe, with the expectation that this therapy may be approved for commercialization in late 2023. The FDA Breakthrough Device Designation is designed to help patients and their physicians receive timely access to technologies that have the potential to provide more effective treatment or diagnosis for debilitating conditions of significant unmet need, such as spinal cord injury. As part of this designation, the FDA will provide ONWARD with priority review and the opportunity to interact with FDA experts throughout the premarket review phase as the technology moves toward eventual commercialization.
“Bladder control, spasticity, and blood pressure dysregulation are three of the many challenges people with spinal cord injury must manage in order to navigate their daily lives,” said Dave Marver, Chief Executive Officer of ONWARD. “We are proud of our eight Breakthrough Device Designations from the FDA, which validate the significant unmet needs of the SCI community and the pioneering nature of our work.”
For additional information about the company, please visit ONWD.com.