ONWARD’s therapy improves hand and arm function in people with spinal chord injury
The first large-scale clinical study of ONWARDS’ non-invasive spinal cord stimulation technology met its primary endpoint: Statistically significant and clinically meaningful improvement in upper extremity strength and function in people with tetraplegia. ONWARD plans to submit for marketing approval in the U.S. and Europe with the goal to launch ARC-EX Therapy in the second half of 2023
The Up-LIFT study is a prospective, single-arm pivotal study designed to evaluate the safety and effectiveness of non-invasive electrical spinal cord stimulation (ARC-EX Therapy) to treat upper extremity functional deficits in people with chronic tetraplegia (paralysis of all four limbs). The study enrolled 65 people at 14 leading spinal chord injury (SCI) centers in the U.S., Europe, and Canada. Time since injury averaged 5.9 years (range 1 to 34 years) with an average subject age of 46.5 years.
Participants completed an average of 50 training sessions over a period of about 4 months. A series of comprehensive assessments were performed at baseline and monthly thereafter to detect changes in sensory and motor function of upper extremities that directly translate into improved functional performance in activities of daily living.
“The Up-LIFT study results represent a turning point in the field of spinal cord injury and paralysis science,” said Marco Baptista, Ph.D., Chief Scientific Officer of the Christopher & Dana Reeve Foundation. Functional recovery once deemed impossible may now be in reach. The Reeve Foundation looks forward to this technology advancing and, we hope, becoming widely available to our community.”
“Our vision is to empower people with spinal cord injury to enjoy life in every way that matters to them. Today’s excellent results from the Up-LIFT study will help us transform that vision into reality”, said Dave Marver, ONWARD CEO. “Our team is working hard to prepare regulatory submissions and to get ready for launch in the U.S. and Europe. We are hopeful we can begin to positively impact the lives of people with spinal cord injury sometime during the second half of 2023.”
ONWARD has received three Breakthrough Device Designations from the U.S. FDA encompassing both ARC-IM and ARC-EX. ARC-EX is an external, non-invasive platform consisting of a wearable stimulator and wireless programmer. ARC-IM consists of an implantable pulse generator and lead that is placed near the spinal cord. The company completed its first-in-human use of the ARC-IM neurostimulator in May 2022.
(Press release / SK)
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