ONWARD Medical N.V. announces it has completed enrollment in the Up-LIFT study, a pivotal trial to evaluate the safety and effectiveness of ARC Therapy to restore hand and arm function in people with spinal cord injury (SCI).
ONWARD has now reached the study’s enrollment ceiling of 65 subjects, enrolled at 14 leading SCI research sites throughout the United States, Canada, the United Kingdom, and the Netherlands. The Up-LIFT Study is a prospective, single-arm study designed to evaluate the safety and effectiveness of non-invasive electrical spinal cord stimulation (ARC Therapy) to treat upper extremity functional deficits in people with chronic tetraplegia.
“The study reached its enrollment objective in under 12 months despite lock-downs, travel restrictions, and other COVID-related challenges. This milestone underscores the SCI community’s enthusiasm for this promising therapy. We will now work with determination to prepare submissions to regulatory authorities in the US and Europe so we can bring this important therapy to market for the benefit of people with SCI and their loved ones.”— Dave Marver, Chief Executive Officer of ONWARD
“For individuals with impaired arm and hand function due to spinal cord injury, improved hand function directly translates into meaningful gains in terms of quality of life – being able to eat, dress or perform other daily life activities. It was very rewarding to take part in this important trial and collaborate with many of the most highly respected SCI rehabilitation centers across the globe.”— Edelle Field-Fote, PT, PhD, FAPTA, FASIA, co-PI of the Up-LIFT trial and Director of Spinal Cord Injury Research at Shepherd Center and Professor of Rehabilitation Medicine at Emory University School of Medicine
“The end of enrollment for this trial marks a significant milestone in bringing non-invasive stimulation for restoring hand and arm function to people living with spinal cord injury. We are hopeful this study can lead to the broad availability of this important therapy.”— Chet Moritz, PhD, co-PI of the Up-LIFT trial and Associate Professor in the Departments of Electrical & Computer Engineering and Rehabilitation Medicine at the University of Washington in Seattle
The company expects to initially commercialize ARC Therapy in the US, Germany, France, UK, Switzerland, and the Netherlands. To learn more about ONWARD’s ARC Therapy and the company’s vision to restore movement, independence and health in people with spinal cord injury, visit ONWARD.
[Source(s): ONWARD, Business Wire]