ONWARD ARC-EX® System Named One of TIME's Best Inventions of 2024
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 ONWD.com.
Note: 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
Paris, 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,
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-BCI™ and ARC Therapy™,
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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