ONWARD Announces First Patient Enrolled in the Up-LIFT Pivotal Trial Assessing Safety and Effectiveness of ARC Therapy for Spinal Cord Injury

ONWARD, formerly known as GTX Medical, today announced the first patient has been enrolled in a pivotal trial evaluating the Company’s ARC Therapy^TM. The pivotal trial, known as Up-LIFT, will evaluate the safety and effectiveness of ARC Therapy in restoring 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. The first patient was enrolled at the Shepherd Center in Atlanta, GA, USA.

“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 day-to-day activities,” said Edelle Field-Fote, PT, PhD, FAPTA, FASIA, co-PI of the Up-LIFT trial and Director of Spinal Cord Injury Research and Professor of Rehabilitation Medicine at Emory University School of Medicine.

“The start of this trial marks a significant milestone in bringing non-invasive stimulation to people living with spinal cord injury, whose top priority is restoring hand and arm function,” said 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. ONWARD plans to enroll 65 subjects at up to 15 sites in the United States, Canada, UK, and Europe.

A study recently published by Chet Moritz and researchers at the University of Washington in Transactions on Neural Systems and Rehabilitation Engineering, a journal of the IEEE, the world’s largest technical professional organization for the advancement of technology, demonstrated ONWARD’s transcutaneous spinal cord stimulation leads to both rapid and sustained recovery of hand and arm function for people with both motor complete and incomplete cervical SCI. These findings further support the potential for non-invasive spinal cord stimulation technology in restoring hand and arm function in this population.

“The initiation of the Up-LIFT trial is an important first step toward delivering meaningful solutions to people living with the effects of spinal cord injury,” said Dave Marver, Chief Executive Officer of ONWARD. “We are deeply committed to our vision to use breakthrough science and pioneering technology to help the spinal cord injury community.”

An arc occurs when an electrical impulse bridges the gap between two conductors. ARC Therapy is designed to re-establish severed connections between spared neural networks and the brain by means of specific, targeted spinal cord stimulation.

To learn more about ONWARD’s ARC therapy technology and mission to restore movement, independence and health in people with spinal cord injury, please visit the newly launched ONWD.com.

About ONWARD

ONWARD (@onwdempowered), formerly known as GTX Medical, is a medical technology company focused on the development and commercialization of innovative therapies to facilitate functional recovery of people with spinal cord injury. Driven by a mission 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 (ARC^IM) or external (ARC^EX) 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. Both of ONWARD’s technology platforms have been awarded Breakthrough Device Designation by the FDA.

ONWARD is headquartered at the High Tech Campus in Eindhoven, the Netherlands and the EPFL Innovation Park in Lausanne, Switzerland, with a growing U.S. presence in Boston, Massachusetts, USA. For additional information about the company, please visit ONWD.com and follow us on Twitter and LinkedIn.

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