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(TM), and ARC Therapy(TM), 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(TM) 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?
media@onwd.com (mailto:media@onwd.com)?
For Investor Enquiries:?
Khaled Bahi, Interim CFO ?
investors@onwd.com (mailto: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(TM) and ARC Therapy(TM), are
investigational and not available for commercial use.
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