The Netherlands-based company published findings from the Up-LIFT pivotal trial in Nature Medicine. Up-LIFT achieved all primary safety and effectiveness endpoints. Additionally, ARC-EX showed significant improvements in upper limb strength, function and sensation among those with chronic tetraplegia due to cervical spinal cord injury (SCI).
Onward ARC-EX therapy delivers targeted, programmed electrical stimulation transcutaneously to the spinal cord. It enables increased strength, movement and function in the upper limbs after SCI.
The company submitted ARC-EX to the FDA for approval last month. It also plans to follow with a European submission.
If approved, the company says ARC-EX would become the first ever SCS therapy that restores hand and arm function after SCI. It would also become the first commercial product for Onward. The company also has its investigational ARC-IM system for improved blood pressure regulation after spinal cord injury and the ARC-BCI system that won FDA breakthrough device designation in February.
A look at the Onward study results
At the end of Up-LIFT, 72% of trial participants were considered responders to non-invasive ARC-EX therapy. Investigators based this designation on a conservative definition requiring responders to meet improvement criteria in both strength and functional domains vs. standard of care rehabilitation alone.
The number of responders increased to 90% when the definition included participants with improvements in at least one strength or functional outcome.
Participants also reported reduced spasm frequency, improved sleep and improved upper body sensation. That included the sense of touch. Onward said 87% of participants reported that ARC-EX therapy delievered improvements in overall quality of life. Self-care, a key component of independence after SCI, also improved significantly, the company said.
“Improvement in arm and hand function is among the highest priorities for people with tetraplegia who have endured far too long without effective therapies for functional recovery,” said Dave Marver, CEO, Onward Medical. “The findings published in Nature Medicine provide critical and compelling evidence that ARC-EX has the potential to restore independence in daily activities and improve quality of life. We are laser-focused on our commitment to bring this first-of-its-kind technology to the SCI community as soon as possible.”
