Sam Brusco, Associate Editor02.24.23
ONWARD Medical, a company creating therapies to restore movement, independence, and health in people with spinal cord injury (SCI), has been granted U.S. Food and Drug Administration (FDA) breakthrough status for use of its ARC-EX platform for bladder control, spasticity alleviation, and blood pressure regulation in people with SCI.
The company has now been awarded eight total Breakthrough Device Designations.
The ARC-EX external, non-invasive platform is a stimulator and wireless programmer. The company’s first pivotal study, Up-LIFT, reported positive top-line data in 2022. The study evaluated ARC-EX therapy to improve upper extremity strength and function.
ONWARD is currently preparing for regulatory submissions in the U.S. and Europe, aiming to achieve approval for commercialization in late 2023.
“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,” Dave Marver, CEO of ONWARD told the press. “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.”
The company has now been awarded eight total Breakthrough Device Designations.
The ARC-EX external, non-invasive platform is a stimulator and wireless programmer. The company’s first pivotal study, Up-LIFT, reported positive top-line data in 2022. The study evaluated ARC-EX therapy to improve upper extremity strength and function.
ONWARD is currently preparing for regulatory submissions in the U.S. and Europe, aiming to achieve approval for commercialization in late 2023.
“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,” Dave Marver, CEO of ONWARD told the press. “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.”