ONWARD Medical N.V. announced it 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. ONWARD has now been awarded a total of eight Breakthrough Device Designations, highlighting the company's innovative approach to developing therapies for people with SCI. 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 commercialization in late 2023. 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 commercialization.