ONWARD ARC Therapy Highlighted at NANS24

ONWARD Medical N.V. presented clinical experience, results, and therapy programming strategies from clinical studies, including the Up-LIFT pivotal study, during the NANS 2024 meeting this week in Las Vegas. The Up-LIFT pivotal study investigated non-invasive neuromodulation to improve upper extremity strength and function after SCI; ARC-EX Therapy met all primary safety and effectiveness endpoints and demonstrated a 72% responder rate.¹ 
 
During the Neuromodulation for Spinal Cord Injury (SCI) main stage presentation, Dr. David Darrow, neurosurgeon and assistant professor at the University of Minnesota; Dr. Claudia Angeli, Ph.D., assistant director of Kessler Foundation; and James Guest, M.D., Ph.D., neurosurgeon and professor of Neurological Surgery at the University of Miami and the Miami Project to Cure Paralysis; discussed SCI-targeted innovations. While bringing awareness to spinal cord injury during a meeting traditionally focused on chronic pain and movement disorders, Guest presented clinical results and his experience from the Up-LIFT pivotal study. 
 
The ARC-EX System, which received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) in 2017 for improved upper limb function, is designed to non-invasively deliver electrical stimulation to the spinal cord.  
 
“We are pleased to see our therapies garner attention on the main stage at NANS, an important society and stakeholder group whose membership will drive access and adoption for ARC Therapy in North America,” ONWARD CEO Dave Marver said. “We are preparing to submit a De Novo application for ARC-EX Therapy to FDA in the near future, leveraging the positive clinical results from the Up-LIFT pivotal study.” 
 
The company’s ARC-EX Therapy was also highlighted in two abstracts accepted by the NANS scientific board, including “Transcutaneous Spinal Cord Stimulation Facilitates Upper Extremity Functional Recovery in Spinal Cord Injury: Results From The Up-LIFT Pivotal Trial” (Guest, Edelle C Field-Fote Ph.D., Candace Tefertiller Ph.D., et al.) and “Transcutaneous Spinal Cord Stimulation Parameters and Programming Strategies for Effective Upper Extremity Rehabilitation Following Tetraplegia” (Chet Moritz Ph.D.,  Field-Fote PT, PhD, Ilse van Nes M.D., Ph.D., et al.).  
 
All ONWARD devices and therapies, including but not limited to ARC-IM, ARC-EX, and ARC Therapy, alone or in combination with a brain-computer interface, are investigational and not available for commercial use. 
 
ONWARD ARC Therapy, which can be delivered by external ARC-EX or implantable ARC-IM systems, is designed to deliver targeted, programmed spinal cord stimulation. Positive results were presented in 2023 from the company’s pivotal study, called Up-LIFT, evaluating the ability for transcutaneous ARC Therapy to improve upper extremity strength and function. ONWARD Medical is now preparing regulatory approval submissions for ARC-EX for the United States and Europe. In parallel, the company is conducting studies with its implantable ARC-IM platform, which demonstrated positive interim clinical outcomes for improved blood pressure regulation, a component of hemodynamic instability, following SCI. Other ongoing studies include combination use of ARC-IM with a brain-computer interface (BCI) to address multiple symptoms of SCI.   
 
ONWARD Medical is a medical technology company creating therapies to restore movement, function, and independence in people with spinal cord injury (SCI) and movement disabilities. Building on more than a decade of science and preclinical research conducted at leading neuroscience laboratories, the company has received nine Breakthrough Device Designations from the FDA for its ARC Therapy platform. Headquartered in Eindhoven, the Netherlands, ONWARD has a Science and Engineering Center in Lausanne, Switzerland, and a U.S. office in Boston. The company also has an academic partnership with .NeuroRestore, a collaboration between the Swiss Federal Institute of Technology and Lausanne University Hospital.  

Reference
¹ Responder defined as a participant who met or exceeded the minimally important difference criteria for at least one outcome of the strength domain and at least one outcome of the functional performance domain.