Nature Medicine Highlights Significant Improvement in Hand and Arm Function After Spinal Cord Injury with Use of ONWARD® ARC-EX® Therapy

ARC Therapy™ shown to be safe and effective in global pivotal trial*

• 90% of participants improved either strength or function of upper limbs*
• Improvement demonstrated in participants up to 34 years post-injury*
• 87% of participants also reported improvement in overall quality of life*

ONWARD Medical N.V. ( Euronext : ONWD), the medical technology company creating innovative spinal cord stimulation therapies to restore movement, function, and independence in people with spinal cord injury (SCI), today announces 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*.

“Trial results far exceeded our hypothesis of a 50% response rate to ARC-EX Therapy, giving new hope to people with SCI and to rehabilitation providers,” said Chet Moritz, Ph.D., publication lead author, co-Principal Investigator, and Professor of Electrical & Computer Engineering and Rehabilitation Medicine at the University of Washington. “After only two months, more than half of Up-LIFT participants achieved average improvements each in grasp force greater than that required to lift filled cups and in pinch force equivalent to that required to pick up an item with a fork or insert a key.1,2 This indicates not only improved strength and function, but also the potential for greater independence with ARC-EX Therapy.”

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*.

“Improvement in arm and hand function is among the highest priorities for people with tetraplegia1 who have endured far too long without effective therapies for functional recovery,” said Dave Marver, CEO, ONWARD Medical. “The findings published in Nature Medicine provide critical and compelling evidence that ARC-EX has the potential to restore independence in daily activities and improve quality of life. We are laser-focused on our commitment to bring this first-of-its-kind technology to the SCI Community as soon as possible.”

“We are proud that ONWARD has developed this first-ever therapy shown to improve strength and function after chronic incomplete tetraplegia,” said ONWARD Medical co-founders Grégoire Courtine, PhD, Professor of Neuroscience and Neurotechnology at the Swiss Federal Institute of Technology Lausanne (EPFL), and Jocelyne Bloch, MD, Head of Functional Neurosurgery at Lausanne University Hospital and Professor of Neurosurgery at EPFL. “We commend the outstanding researchers and study participants who contributed to this seminal trial.”

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 Q1, 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.

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Note: All ONWARD® Medical devices and therapies, including but not limited to ARC-IM®, ARC-EX®, ARC-BCI™, and ARC Therapy™, alone or in combination with a brain-computer interface (BCI), are investigational and not available for commercial use. * Moritz, Chet, et al. “Non-invasive spinal cord stimulation for arm and hand function in chronic tetraplegia: a safety and efficacy trial.” Nature Medicine. 2024.

1 Feingold-Polak, Ronit, et al. “The effects of an object's height and weight on force calibration and kinematics when post-stroke and healthy individuals reach and grasp.” Scientific Reports. 2021.

2 Smaby, Niels, et al. “Identification of key pinch forces required to complete functional tasks.” Journal of Rehabilitation Research & Development. 2004.