ONWARD Medical, a medical technology company focused on spinal cord injury (SCI), has been 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.
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FDA approval stamp
ONWARD has now been awarded a total of eight Breakthrough Device Designations. ARC-EX is an external, non-invasive platform consisting of a stimulator and wireless programmer. Positive top-line data were reported in 2022 from the company’s first pivotal study, called Up-LIFT, which evaluated the ability for ARC-EX Therapy to improve upper extremity strength and function. ONWARD is now preparing regulatory submissions for the U.S. and Europe, with the expectation that this therapy may be approved for commercialisation in late 2023.
Dave Marver, chief executive officer of ONWARD, said: “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. We are proud of our eight total Breakthrough Device Designations from the FDA, which validate the significant unmet needs of the SCI community and the pioneering nature of our work.”
Breakthrough Device Designation is an FDA program 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 commercialisation.
