Onward Medical recently announced that the Up-LIFT pivotal study evaluating its non-invasive spinal cord stimulation (SCS) ARC-EX therapy achieved its primary effectiveness endpoint of improvement in upper extremity strength and function in patients with movement disabilities.
“Restoring hand and arm function after spinal cord injury [SCI] is life-changing, freeing people with paralysis to feed and care for themselves, and be more independent in everyday activities,” said the study’s co-principal investigator (PI) Chet Moritz (University of Washington, Seattle, USA).
“We are grateful to the many therapists, clinicians and people with SCI who participated in this landmark study,” added co-PI Edelle Field-Fote (Emory University, Atlanta, USA). “There was very low attrition over thousands of clinic visits, a testament to the collective enthusiasm for this compelling therapy and for everyone’s determination to find new treatment options for people with SCI.”
The Up-LIFT study is a prospective, single-arm pivotal study designed to evaluate the safety and effectiveness of non-invasive electrical SCS (ARC-EX therapy) to treat upper extremity functional deficits in people with chronic tetraplegia. The study enrolled 65 people at 14 leading SCI centres across the USA, Europe and Canada. Time since injury averaged 5.9 years (range 1–34 years) with an average subject age of 46.5 years.
Detailed results will be made available after review by the US Food and Drug Administration (FDA), according to an Onward press release. The company plans to submit for regulatory approval in both the USA and Europe within the next six months.
Up-LIFT participants completed an average of 50 training sessions over a period of about 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. 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’s ARC-EX therapy with a standard-of-care rehabilitation. An independent data safety monitoring board adjudicated the safe conduct of the study, the release states.
“The Up-LIFT study results represent a turning point in the field of SCI and paralysis science,” said 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.”
“Our team is working hard to prepare regulatory submissions and to get ready for launch in the USA and Europe,” added Onward CEO Dave Marver. “We are hopeful we can begin to positively impact the lives of people with SCI sometime during the second half of 2023.”