Sam Brusco, Associate Editor04.02.24
ONWARD Medical has submitted its De Novo application to the U.S. Food and Drug Administration (FDA) for its breakthrough ARC-EX system to restore upper extremity function after spinal cord injury (SCI).
Once cleared by the FDA, ARC-EX will become the first-ever spinal cord stimulation therapy to restore hand and arm function following SCI. It will also be ONWARD’s first commercial product.
The company said it prioritized upper limb function as ARC-EX’s first indication because of feedback from the SCI community about the importance of arm, hand, and finger function to empower independence after SCI.
The De Novo application follows the company’s Up-LIFT global, pivotal trial—the first large-scale pivotal study of transcutaneous spinal cord stimulation. The study investigated ARC-EX in improving upper limb strength and function in 65 study participants with chronic tetraplegia at 14 leading SCI neurorehabilitation centers in the U.S., Canada, the UK, and the Netherlands.
The study met all primary safety and effectiveness endpoints and showed 72% of participants responded to ARC-EX Therapy, showing improvement in both strength and function.
The ARC-EX system delivers ARC-EX therapy—targeted, programmed electrical stimulation—transcutaneously to the spinal cord to increase upper limb strength, movement, and function after SCI. The system was previously awarded FDA Breakthrough Device Designation for upper limb function.
ONWARD said its next move is to prepare for regulatory submission in Europe. The company also has an investigational implantable version of ARC therapy (ARC-IM) and a brain-computer interface (ARC-BCI) in development.
“We are delighted to be one step closer to bringing our breakthrough ARC-EX System to people living with SCI after submitting this De Novo application for regulatory clearance in the United States,” said ONWARD Medical CEO Dave Marver. “This therapy has the potential to transform the lives of people living with paralysis, while also positively impacting their loved ones.”
Once cleared by the FDA, ARC-EX will become the first-ever spinal cord stimulation therapy to restore hand and arm function following SCI. It will also be ONWARD’s first commercial product.
The company said it prioritized upper limb function as ARC-EX’s first indication because of feedback from the SCI community about the importance of arm, hand, and finger function to empower independence after SCI.
The De Novo application follows the company’s Up-LIFT global, pivotal trial—the first large-scale pivotal study of transcutaneous spinal cord stimulation. The study investigated ARC-EX in improving upper limb strength and function in 65 study participants with chronic tetraplegia at 14 leading SCI neurorehabilitation centers in the U.S., Canada, the UK, and the Netherlands.
The study met all primary safety and effectiveness endpoints and showed 72% of participants responded to ARC-EX Therapy, showing improvement in both strength and function.
The ARC-EX system delivers ARC-EX therapy—targeted, programmed electrical stimulation—transcutaneously to the spinal cord to increase upper limb strength, movement, and function after SCI. The system was previously awarded FDA Breakthrough Device Designation for upper limb function.
ONWARD said its next move is to prepare for regulatory submission in Europe. The company also has an investigational implantable version of ARC therapy (ARC-IM) and a brain-computer interface (ARC-BCI) in development.
“We are delighted to be one step closer to bringing our breakthrough ARC-EX System to people living with SCI after submitting this De Novo application for regulatory clearance in the United States,” said ONWARD Medical CEO Dave Marver. “This therapy has the potential to transform the lives of people living with paralysis, while also positively impacting their loved ones.”