Nature Medicine published Up-LIFT pivotal trial results

Company will discuss pivotal trial results during webcast this week with company leaders and study principal investigators and participants

EINDHOVEN, the Netherlands, May 21, 2024 (GLOBE NEWSWIRE) -- ONWARD Medical N.V. (Euronext: ONWD), the medical technology company creating innovative spinal cord stimulation therapies to restore movement, function, and independence in people with spinal cord injury (SCI), today announces that on Thursday, May 23^rd at 2:30pm CET/8:30am ET following a brief Q1 Business Update, CEO Dave Marver will host a discussion of Up-LIFT pivotal trial results with a panel of company leaders, study principal investigators, and study participants. The Up-LIFT trial demonstrated the safety and effectiveness of external ARC-EX Therapy to improve hand and arm function after spinal cord injury.

Panelists will include Up-LIFT principal investigators Drs. Jim Guest, Chet Moritz, and Candace Tefertiller, trial participants Sherown Campbell and Jessie Owen, and ONWARD Medical VP Clinical, Regulatory, and Quality Erika Ross Ellison.

To join the webcast via Zoom, please register using this link.

Participants may also join by phone:

+32 2 290 9360 (Belgium)

+33 1 7037 2246 (France)

+49 69 3807 9884 (Germany)

+31 20 794 0854 (Netherlands)

+41 22 591 0156 (Switzerland)

+44 203 481 5240 (United Kingdom)

+1 346 248 7799 (US)

Additional telephone numbers available

Meeting ID: 879 5741 2479

A recording of the webcast will be available on the Company’s website following the live event.

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 ONWD.com.

*All ONWARD^® Medical devices and therapies, including but not limited to ARC-IM^®, ARC-EX^®, ARC-BCI™, and ARC Therapy™, 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 Therapy™, 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-BCI™ 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 Brussels and Amsterdam (ticker: ONWD).

For more information, visit ONWD.com, and connect with us on LinkedIn and YouTube.

For Media Inquiries:
Aditi Roy, VP Communications
media@onwd.com

For Investor Inquiries:
Amori Fraser, Finance Director
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. 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-BCI™ and ARC Therapy™, are investigational and not available for commercial use.

This item of content is a press release from a third party provider who make no warranties or representations in connection with this content and therefore PA can make no warranties in respect of its use.

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