EINDHOVEN, the Netherlands - 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 UpLIFT 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.

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.).

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.

Contact:

Aditi Roy

Email: media@onwd.com

Khaled Bahi

Email: investors@onwd.com

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. 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.

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