Up-LIFT research achieves primary endpoint with improvement in arm and hand function
ONWARD – the medical technology company creating therapies to restore movement, independence and health in people with spinal cord injury – has announced that the Up-LIFT pivotal study evaluating ARC-EX Therapy achieved its primary effectiveness endpoint of improvement in upper extremity strength and function.
ARC-EX Therapy is a proprietary non-invasive spinal cord stimulation technology designed to restore movement and other functions in people with movement disabilities.
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 to treat upper extremity functional deficits in people with chronic tetraplegia (paralysis of all four limbs).
The study enrolled 65 people at 14 centres across Europe, the US and Canada. Time since injury averaged 5.9 years with an average subject age of around 46 years. The company plans to submit for regulatory approval in both the US and Europe within the next six months.
Participants completed an average of 50 training sessions over a period of four 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.
Meanwhile, rigorous measures such as pinch and grasp force were used to detect clinically meaningful changes resulting from the combination of ONWARD ARC-EX Therapy with a standard of care rehabilitation. An independent data safety monitoring board adjudicated the safe conduct of the study.
“The Up-LIFT study results represent a turning point in the field of spinal cord injury and paralysis science,” reflected Marco Baptista, 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.”
Dave Marver, ONWARD’s chief executive officer, said: “Our team is working hard to prepare regulatory submissions and to get ready for launch in the US 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.”