Study will Evaluate Safety and Performance of ARCEX Therapy for Spinal Cord Injury in Home Setting
EINDHOVEN, the Netherlands & LAUSANNE, Switzerland–(BUSINESS WIRE)–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, today announces the start of enrollment in the LIFT Home Study. The trial is designed to study the safety and performance of ARCEX Therapy when used in the home.
ONWARD’s ARCEX Therapy is externally delivered programmed stimulation of the spinal cord to restore strength and function in people with spinal cord injury and other movement related challenges. The study will enroll up to 20 participants at 5 leading research centers in the United States: Craig Hospital in Denver, Colorado, Shepherd Center in Atlanta, Georgia, Spaulding Research Institute in Boston, Massachusetts, University of Minnesota, and University of Washington. Subjects will be followed for four weeks to assess whether continued access to ONWARD’s ARCEX Therapy is safe and can be used to enhance long-term benefit.
The first participants have been enrolled at Craig Hospital under the supervision of study principal investigator, Candy Tefertiller, PT, DPT, Ph.D., NCS, Executive Director of Research and Evaluation at Craig and at the University of Washington in Seattle by Chet Moritz, PhD, Associate Professor in the Departments of Electrical& Computer Engineering and Rehabilitation Medicine. “The LIFT Home Study is an important next step in understanding the potential benefits people with spinal cord injury may derive from continued access to ARC Therapy outside the clinic,” said Dr. Tefertiller.
The LIFT Home Study is a successor to ONWARD’s Up-LIFT Study, a pivotal trial that completed enrollment of 65 participants in December 2021, with participating research centers in the US, Canada, the UK, and Europe. Up-LIFT is designed to demonstrate ONWARD ARCEX Therapy can improve the strength and function of upper limbs when used in the rehabilitation clinic setting. The LIFT Home Study seeks to evaluate the potential impact of ARCEX Therapy when used in the home setting.
“We are pleased to collaborate with an outstanding group of researchers to investigate new potential benefits and care settings for our ARCEX Therapy,” said Dave Marver, CEO of ONWARD. “This is another step in our journey to help people with spinal cord injury live better, more independent lives.”
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.
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, completed enrollment in December 2021 with 65 subjects worldwide.
ONWARD is headquartered at the High Tech Campus in Eindhoven, the Netherlands. It maintains a significant team in Lausanne, Switzerland and has a growing U.S. presence in Boston, Massachusetts, USA. For additional information about the company, please visit ONWD.com. To access our 2022 Financial Calendar, please visit IR.ONWD.com.
Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company or, as appropriate, the Company directors’ current expectations and projections about future events. By their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future. As a result, the Company expressly disclaims any obligation or undertaking to release any update or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person’s officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.
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