Nature Medicine Highlights Significant Improvement in Hand and Arm Function After Spinal Cord Injury with Use of ONWARD ARC-EX Therapy

ARC Therapy shown to be safe and effective in global pivotal trial*

90% of participants improved either strength or function of upper limbs*

Improvement demonstrated in participants up to 34 years post-injury*

87% of participants also reported improvement in overall quality of life*

EINDHOVEN, the Netherlands, May 20, 2024 (GLOBE NEWSWIRE) -- ONWARD Medical N.V. (Euronext: ONWD), the medical technology company creating innovative spinal cord stimulation therapies to restore movement, function, and independence in people with spinal cord injury (SCI), today announces the publication of global Up-LIFT pivotal trial results in Nature Medicine. The study achieved all primary safety and effectiveness endpoints, and ARC-EX Therapy demonstrated significant improvements in upper limb strength, function, and sensation among people with chronic tetraplegia due to cervical SCI.

At the end of the trial, 72% of trial participants were considered responders to non-invasive ARC-EX Therapy* based on a conservative definition requiring responders to meet improvement criteria in both strength and functional domains vs. standard of care rehabilitation alone. Notably, the number of responders increased to 90% when the definition included participants with improvements in at least one strength or functional outcome*.

“Trial results far exceeded our hypothesis of a 50% response rate to ARC-EX Therapy, giving new hope to people with SCI and to rehabilitation providers,” said Chet Moritz, Ph.D., publication lead author, co-Principal Investigator, and Professor of Electrical & Computer Engineering and Rehabilitation Medicine at the University of Washington. “After only two months, more than half of Up-LIFT participants achieved average improvements in grasp force greater than that required to lift filled cups and in pinch force equivalent to that required to pick up an item with a fork or insert a key.^1,2 This indicates not only improved strength and function, but also the potential for greater independence with ARC-EX Therapy.”

Study participants also reported reduced spasm frequency, improved sleep, and improved upper body sensation, including the sense of touch*. 87% of participants reported that ARC-EX Therapy delivered improvements in overall quality of life*. Self-care, a key component of independence after SCI, also improved significantly*.

“Improvement in arm and hand function is among the highest priorities for people with tetraplegia³ 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.”