ONWARD Medical N.V. 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 (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 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. Detailed results will be made available after review by the FDA.

The company plans to submit for regulatory approval in both the US and Europe within the next 6 months. 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.

Rigorous measures such as CUE-T, GRASSP, ISNCSCI iii and 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. Spinal cord injury (SCI) represents a major unmet medical need for which there is no cure.

Approximately 7 million people globally have a spinal cord injury, with over 650,000 in the U.S. and Europe alone. The quality of life of people with SCI can be poor, with paralysis and loss of sensation, issues with blood pressure control and trunk stability, increased potential for infection, incontinence, and loss of sexual function. Assistance is required for daily living activities.

And SCI is costly, with the average lifetime cost for a paraplegic (paralysis of the legs) of $2.5 million and $5 million for a tetraplegic (paralysis of all four limbs). Treatments are urgently needed to restore movement and improve quality of life.