ONWARD Medical N.V. announced 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. 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. ARC-EX Therapy is external, programmed electrical stimulation that targets the spinal cord non-invasively and is designed to aid in functional recovery after SCI.

The Up-LIFT study was a prospective, single-arm pivotal study designed to evaluate the safety and effectiveness of the ARC-EX System to treat upper extremity functional deficits in people with chronic tetraplegia. The global study was conducted with 65 participants at 14 leading SCI centers in the United States, Europe, and Canada. At the end of the first quarter, ONWARD Medical submitted a De Novo application to the US Food and Drug Administration for market clearance of the ARC-EX System.

The Company plans to follow the US application with an application for market approval in Europe.