ONWARD has announced that it has completed enrolment in the Up-LIFT study, a pivotal trial that aims to evaluate the safety and effectiveness of its ARC Therapy to restore hand and arm function in people with spinal cord injury (SCI). According to the company, Up-LIFT is the first large-scale pivotal trial of non-invasive spinal cord stimulation technology.
ONWARD recently reached the study’s enrolment ceiling of 65 subjects, enrolled at 14 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.
Dave Marver, chief executive officer of ONWARD, said: “The study reached its enrolment 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.”
Edelle Field-Fote, co-principal investigator of the Up-LIFT trial and director of spinal cord injury research at the Shepherd Centre (Atlanta, USA), added: “For individuals with impaired arm and hand function due to SCI, 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 centres across the globe.”
Fellow co-principal investigator, Chet Moritz, who is also associate professor in the departments of electrical and computer engineering and rehabilitation medicine at the University of Washington (Seattle, USA), commented: “The end of enrolment for this trial marks a significant milestone in bringing non-invasive stimulation for restoring hand and arm function to people living with SCI. We are hopeful this study can lead to the broad availability of this important therapy.”