EINDHOVEN, the Netherlands, Jan. 25, 2024 (GLOBE NEWSWIRE) -- ONWARD Medical N.V. (Euronext: ONWD), the medical technology company creating innovative therapies to restore movement, function, and independence in people with spinal cord injury (SCI), today announced that clinical experience, results, and therapy programming strategies from clinical studies, including the Up-LIFT pivotal study, were presented during the NANS 2024 meeting in Las Vegas, Nevada, USA. 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 rate1.
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 PhD, Assistant Director of Kessler Foundation, and Dr. James Guest, 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, Dr. Guest presented clinical results and his experience from the Up-LIFT pivotal study.
Neurosurgeon Dr. James Guest discusses investigational ARC-EX Therapy for functional recovery of upper extremities after SCI on the main stage at NANS 2024
The ARC-EX System, which received Breakthrough Device Designation from the US Food & Drug Administration 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 innovative 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,” said Dave Marver, ONWARD CEO. “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 (James Guest MD, PhD, Edelle C Field-Fote PT, PhD, Candace Tefertiller DPT, PhD, et al.) and Transcutaneous Spinal Cord Stimulation Parameters and Programming Strategies for Effective Upper Extremity Rehabilitation Following Tetraplegia (Chet Moritz PhD, Edelle C Field-Fote PT, PhD, Ilse van Nes MD, PhD, et al.).
All ONWARD devices and therapies, including but not limited to ARC-IM®, ARC-EX, and ARC Therapy, alone or in combination with BCI, are investigational and not available for commercial use.
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.
About ONWARD Medical
ONWARD 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 US Food and Drug Administration for its ARC Therapy™ platform.
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. The Company is now preparing regulatory approval submissions for ARC-EX for the US 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.
Headquartered in Eindhoven, the Netherlands, ONWARD has a Science and Engineering Center in Lausanne, Switzerland and a US office in Boston, Massachusetts. The Company also has an academic partnership with .NeuroRestore, a collaboration between the Swiss Federal Institute of Technology (EPFL), and Lausanne University Hospital (CHUV).
For more information, visit ONWD.com, and connect with us on LinkedIn and YouTube.
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Disclaimer
Certain statements, beliefs, and opinions in this press release are forward-looking, which reflect the Company’s or, as appropriate, the Company directors’ current expectations and projections about future events. By their nature, forward-looking statements involve several 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. All ONWARD devices and therapies referenced here, including but not limited to ARC-IM, ARC-EX, and ARC Therapy, are investigational and not available for commercial use.
