THIS PRESS RELEASE CONTAINS INSIDE INFORMATION WITHIN THE MEANING OF ARTICLE
7(1) OF THE EUROPEAN MARKET ABUSE REGULATION (596/2014)
EINDHOVEN, the Netherlands, April 02, 2024 (GLOBE NEWSWIRE) -- 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 Therapy(1), 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(TM) - 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(TM), and ARC Therapy(TM), alone or in combination with a
brain-computer interface (BCI), are investigational and not available for
commercial use.
(1)Responder 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.
(2)NSCISC 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(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 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 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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