Studie evalueert veiligheid en prestaties van ARCEX-therapie voor ruggenmergletsel in thuisomgeving
EINDHOVEN, Nederland & LAUSANNE, Zwitserland–(BUSINESS WIRE)– ONWARD Medical N.V. (Euronext: ONWD), het medische technologiebedrijf dat innovatieve therapieën ontwikkelt om beweging, onafhankelijkheid en gezondheid te herstellen bij mensen met een dwarslaesie, kondigt vandaag de voltooiing aan van inschrijving voor de LIFT Thuisstudie. De proef is bedoeld om de veiligheid en prestaties van ARCEX Therapy bij thuisgebruik te bestuderen.
ONWARD’s ARCEX-therapie is extern geleverde geprogrammeerde stimulatie van het ruggenmerg om kracht en functie te herstellen bij mensen met een dwarslaesie en andere bewegingsgerelateerde problemen. Aan de studie namen 17 deelnemers deel aan 5 toonaangevende onderzoekscentra in de Verenigde Staten: Craig Hospital in Denver, Colorado, Shepherd Center in Atlanta, Georgia, Spaulding Research Institute in Boston, Massachusetts, University of Minnesota en University of Washington. De proefpersonen werden gedurende vier weken gevolgd om te beoordelen of voortdurende toegang tot ONWARD’s ARCEX-therapie veilig is en kan worden gebruikt om het langetermijnvoordeel te vergroten.
Enrollment Completed in ONWARD’s LIFT Home Study
Study Evaluates 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 completion 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 enrolled 17 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 were 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.
Candy Tefertiller, PT, DPT, Ph.D., NCS, Executive Director of Research and Evaluation at Denver’s Craig Hospital served as Primary Investigator. “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. ”We are pleased enrollment is now complete and we look forward to completing follow-up activities.”
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 grateful to collaborate with these outstanding 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 regain function and independence.”
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. The company completed first-in-human use of its ARCIM neurostimulator in May 2022.
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. To access our 2022 Financial Calendar, please visit IR.ONWD.com.
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