ONWARD ARC-EX® System Named One Of TIME's Best Inventions Of 2024

(MENAFN- GlobeNewsWire - Nasdaq) EINDHOVEN, the Netherlands, Oct. 31, 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 announces its investigational ARC-EX System has been named one of TIME's Best Inventions of 2024.

"We are grateful for TIME's recognition of the ARC-EX System, which has the potential to impact hundreds of thousands of people with spinal cord injury and impaired hand and arm function," said Dave Marver, CEO of ONWARD Medical. "SCI is a devastating injury that can change lives in an instant. We are hopeful ARC-EX Therapy is just the first of many innovative therapies ONWARD Medical can introduce for the benefit of the Spinal Cord Injury Community."

TIME's annual list features 200 extraordinary innovations changing lives. The selection process involved nominations from TIME editors and correspondents around the world, with special attention paid to growing fields including healthcare, AI, and green energy. Each contender was evaluated based on key factors including originality, efficacy, ambition, and impact.

The high-profile recognition from TIME arrives when many Americans are learning about the challenges associated with spinal cord injury from the feature film, Super/Man: The Christopher Reeve Story , currently in wide release in US theaters.

“The ARC-EX System provides hope for the millions of people suffering from spinal cord injury,” said Chet Moritz, PhD, Professor of Rehabilitation Medicine at the University of Washington. "Every day we work with people who share how much this advance could change their lives – to be able to grasp a toothbrush, hold a cup, or hug their children. With ARC-EX Therapy, we have seen people with no hand function regain the ability to play the guitar or paint, and return to living independently or raising a family without the need for caregiver assistance. We're so appreciative of TIME for acknowledging the inventive nature of this technology."

Selection of the ARC-EX System follows this year's published results of the Up-LIFT pivotal trial in Nature Medicine, which demonstrated significant improvements in upper limb strength and function in people with spinal cord injury. ONWARD Medical has submitted its regulatory application to the FDA for clearance of the ARC-EX System in the US and plans to launch the therapy later this year, pending a positive decision from FDA.

SCI affects approximately seven million people globally, and nearly 300,000 people are living with SCI in the United States. For these individuals, the loss of arm and hand function is cited as the most devastating consequence, with more than 75% ranking it as their highest priority for recovery. According to the Up-LIFT trial results, 90% of SCI participants experienced improved strength or function, and 87% reported improvements in overall quality of life.1

To learn more about ONWARD Medical's commitment to partnering with the SCI Community to develop innovative solutions for restoring movement, function, and independence after spinal cord injury, please visit .

Note: All ONWARD® Medical devices and therapies, including but not limited to ARC-IM®, ARC-EX®, ARC-BCITM, and ARC TherapyTM, alone or in combination with a brain-computer interface (BCI), are investigational and not available for commercial use.

About ONWARD Medical

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 scientific discovery, preclinical, and clinical research conducted at leading hospitals, rehabilitation clinics, and neuroscience laboratories, the Company has developed ARC TherapyTM, which has been awarded ten Breakthrough Device Designations from the US Food and Drug Administration (FDA).

ONWARD ARC Therapy is targeted, programmed spinal cord stimulation designed to be delivered by the Company's external ARC-EX® or implantable ARC-IM® platforms. ARC Therapy can also be delivered by the Company's ARC-BCITM platform, which pairs the ARC-IM System with brain-computer interface (BCI) technology to restore movement after SCI with thought-driven control.

Use of non-invasive ARC-EX Therapy significantly improved upper limb function after SCI in the global pivotal Up-LIFT trial, with results published by Nature Medicine in May 2024. The Company has submitted its regulatory application to the FDA for clearance of the ARC-EX System in the US and is preparing for regulatory submission in Europe. In parallel, the Company is conducting clinical studies with its ARC-IM Therapy, which demonstrated positive interim clinical outcomes for improved blood pressure regulation following SCI. Other ongoing clinical studies focus on using ARC-IM Therapy to address mobility after SCI and gait challenges in Parkinson's disease as well as using the ARC-BCI platform to restore thought-driven movement of both upper and lower limbs after SCI.

Headquartered in Eindhoven, the Netherlands, ONWARD Medical has a Science and Engineering Center in Lausanne, Switzerland and a US office in Boston, Massachusetts. The Company is listed on Euronext Paris, Brussels, and Amsterdam (ticker: ONWD).

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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, delays in regulatory approvals, 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 Medical devices and therapies referenced here, including but not limited to ARC-IM®, ARC-EX®, ARC-BCITM and ARC TherapyTM, are investigational and not available for commercial use.

1 Moritz, Chet, et al.“Non-invasive spinal cord stimulation for arm and hand function in chronic tetraplegia: a safety and efficacy trial.” Nature Medicine. 2024.

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