ONWARD Medical N.V. (Euronext: ONWD), the medical technology
company creating innovative spinal cord stimulation therapies to
improve or restore movement, function, and independence in people
with spinal cord injury (SCI), today announces it has submitted its
De Novo application to the US Food and Drug Administration (FDA) to
allow marketing of its breakthrough ARC-EX System to restore
function of the upper extremities after SCI.
The submission marks an historic milestone for the Company in
its mission to restore mobility and function for people with SCI.
Once cleared by the FDA, ARC-EX will be the first-ever spinal cord
stimulation therapy to restore hand and arm function after SCI and
the first commercial product for ONWARD Medical. ONWARD prioritized
upper limb function as its first indication for the ARC-EX System
given feedback from the SCI Community of the importance of arm,
hand, and finger function in empowering independence after SCI.
“We are delighted to be one step closer to bringing our
breakthrough ARC-EX System to people living with SCI after
submitting this De Novo application for regulatory clearance in the
United States,” said ONWARD Medical CEO Dave Marver. “This therapy
has the potential to transform the lives of people living with
paralysis, while also positively impacting their loved ones.”
The De Novo application follows the Company’s global pivotal
study - called Up-LIFT - the first large-scale pivotal study of
transcutaneous spinal cord stimulation. The study investigated the
safety and effectiveness of ARC-EX Therapy in improving upper limb
strength and function in 65 study participants with chronic
tetraplegia at 14 leading SCI neurorehabilitation centers in the
United States, Canada, the United Kingdom, and the Netherlands. The
study met all primary safety and effectiveness endpoints and
demonstrated that 72% of participants responded to ARC-EX Therapy1,
showing improvement both in strength and function.
“The SCI Community is eager to have access to this innovative
technology,” said Candy Tefertiller, PT, DPT, PhD, NCS, Executive
Director of Research and Evaluation, Craig Hospital in Lakewood,
Colorado. “Even a small difference in hand and arm function can
have a profound impact on independence and quality of life. The
results of the Up-LIFT trial that led to this submission represent
a significant advancement in the use of neuromodulation for
individuals with spinal cord injury.”
The ONWARD ARC-EX System delivers ARC-EX Therapy™ - targeted,
programmed electrical stimulation – transcutaneously to the spinal
cord to increase strength, movement, and function of the upper
limbs after SCI. The ARC-EX System was previously awarded FDA
Breakthrough Device Designation (BDD) for upper limb function,
which provided prioritized FDA review, the opportunity to interact
with FDA experts, and the potential for additional
reimbursement.
Nearly 200,000 people in the US and Europe have incomplete
impaired upper extremity function after spinal cord injury.2,3 The
Company is preparing for regulatory submission in Europe next.
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.
1Responder was defined as a participant who met or exceeded the
minimally important difference criteria for at least one outcome of
the strength domain and at least one outcome of the functional
performance domain.2NSCISC Annual Report, US and Europe only, World
Health Organization Fact Sheet, November 2013, estimate 40-80 cases
per million 3 Kumar et al. 2018, Traumatic Spinal Injury: Global
Epidemiology and Worldwide Volume
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 has submitted
its De Novo regulatory clearance submission for ARC-EX for the US
and is preparing for regulatory submission in 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
Communicationsmedia@onwd.com
For Investor Enquiries:Khaled Bahi, Interim
CFOinvestors@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.
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