Atlanta, GA,
16
December
2021
|
16:16 PM
America/New_York

ONWARD Announces Completion of Enrollment in the Up-LIFT Pivotal Trial of ARC Therapy for Spinal Cord Injury

Shepherd Center serves as one of the leading institutions participating in the trial.

Edelle Field-Fote, PT, Ph.D., FAPTA

ONWARD Medical N.V. (Euronext: ONWD), the medical technology company creating innovative therapies to restore movement, independence, and health in people with spinal cord injury, has announced that 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). Up-LIFT is the first large-scale pivotal trial of non-invasive spinal cord stimulation technology. Shepherd Center is one of the leading sites participating in the trial.

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,” said Dave Marver, chief executive officer of ONWARD. “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.”

“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,” said Edelle Field-Fote, PT, Ph.D., FAPTA, FASIA, co-principal investigator 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. “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.”

“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” said Chet Moritz, Ph.D., 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. “We are hopeful this study can lead to the broad availability of this important therapy.”

The company expects to initially commercialize ARC Therapy in the U.S., 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, please visit ONWD.com.

For more information on research at Shepherd Center, click here

About Shepherd Center

Shepherd Center, located in Atlanta, Georgia, is a private, not-for-profit hospital specializing in medical treatment, research and rehabilitation for people with spinal cord injury, brain injury, multiple sclerosis, spine and chronic pain, and other neurological conditions. Founded in 1975, Shepherd Center is ranked by U.S. News & World Report among the top 10 rehabilitation hospitals in the nation. In its more than four decades, Shepherd Center has grown from a six-bed rehabilitation unit to a world-renowned, 152-bed hospital that treats more than 740 inpatients, nearly 280 day program patients and more than 7,100 outpatients each year in more than 46,000 visits.

About ONWARD

ONWARD is a medical technology company creating innovative therapies to restore movement, independence, and health in people with spinal cord injury. ONWARD’s work builds on more than a decade of basic science and preclinical research conducted at the world’s leading neuroscience laboratories. ONWARD’s ARC Therapy, which can be delivered by implantable (ARCIM) or external (ARCEX) systems, is designed to deliver targeted, programmed stimulation of the spinal cord to restore movement and other functions in people with spinal cord injury, ultimately improving their quality of life. ONWARD has received three Breakthrough Device Designations from the FDA encompassing both ARCIM and ARCEX. The company’s first FDA pivotal trial, called Up-LIFT, commenced in January 2021 and has now completed enrollment with 65 subjects worldwide.

ONWARD is headquartered at the High Tech Campus in Eindhoven, the Netherlands. It maintains an office at the EPFL Innovation Park in Lausanne, Switzerland and has a growing U.S. presence in Boston, Massachusetts, USA. For additional information about the company, please visit ONWD.com.