Third-party tests from leading US lab confirm printed circuit board assembly (PCBA) conforms to prevailing international electrical standards, a requirement for commercial launch
THIS PRESS RELEASE CONTAINS INSIDE INFORMATION WITHIN THE MEANING OF ARTICLE 7(1) OF THE EUROPEAN MARKET ABUSE REGULATION (596/2014)
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EINDHOVEN, the Netherlands, March 18, 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 receipt of a positive report from a leading US-based medical equipment testing laboratory confirming its investigational ARC-EX System conforms to prevailing electrical standards, a requirement for commercial launch.
Last year, the Company announced its decision to update the ARC-EX printed circuit board assembly. With the positive testing report, the Company moves closer to meeting regulatory obligations for market launch.
The ONWARD ARC-EX System is designed to improve upper extremity movement after paralysis caused by spinal cord injury.
"The positive tests are an important milestone on our path to commercialize the external, non-invasive ARC-EX System in the US later this year," said ONWARD Medical CEO Dave Marver. "We are now one step closer to bringing this breakthrough therapy to the SCI Community."
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 science and preclinical research conducted at leading neuroscience laboratories, the Company has received ten 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 Medical 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).
ONWARD Medical 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 Enquiries:??
Aditi Roy, VP Communications?
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Khaled Bahi, Interim CFO -
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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 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.
