ARC Therapy(TM) shown to be safe and effective in global pivotal trial*

    90% of participants improved either strength or function of upper limbs*
      Improvement demonstrated in participants up to 34 years post-injury*
   87% of participants also reported improvement in overall quality of life*

EINDHOVEN, the Netherlands, May 20, 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 the publication of global Up-LIFT
(https://clinicaltrials.gov/study/NCT04697472) pivotal trial results in Nature
Medicine (https://www.nature.com/articles/s41591-024-02940-9). The study
achieved all primary safety and effectiveness endpoints, and ARC-EX Therapy
demonstrated significant improvements in upper limb strength, function, and
sensation among people with chronic tetraplegia due to cervical SCI.
At the end of the trial, 72% of trial participants were considered responders to
non-invasive ARC-EX Therapy* based on a conservative definition requiring
responders to meet improvement criteria in both strength and functional domains
vs. standard of care rehabilitation alone. Notably, the number of responders
increased to 90% when the definition included participants with improvements in
at least one strength or functional outcome*.
"Trial results far exceeded our hypothesis of a 50% response rate to ARC-EX
Therapy, giving new hope to people with SCI and to rehabilitation providers,"
said Chet Moritz, Ph.D., publication lead author, co-Principal Investigator, and
Professor of Electrical & Computer Engineering and Rehabilitation Medicine at
the University of Washington. "After only two months, more than half of Up-LIFT
participants achieved average improvements in grasp force greater than that
required to lift filled cups and in pinch force equivalent to that required to
pick up an item with a fork or insert a key.(1)(,)(2) This indicates not only
improved strength and function, but also the potential for greater independence
with ARC-EX Therapy."
Study participants also reported reduced spasm frequency, improved sleep, and
improved upper body sensation, including the sense of touch*. 87% of
participants reported that ARC-EX Therapy delivered improvements in overall
quality of life*. Self-care, a key component of independence after SCI, also
improved significantly*.
"Improvement in arm and hand function is among the highest priorities for people
with tetraplegia(3) who have endured far too long without effective therapies
for functional recovery," said Dave Marver, CEO, ONWARD Medical. "The findings
published in Nature Medicine provide critical and compelling evidence that ARC-
EX has the potential to restore independence in daily activities and improve
quality of life. We are laser-focused on our commitment to bring this first-of-
its-kind technology to the SCI Community as soon as possible."
"We are proud that ONWARD has developed this first-ever therapy shown to improve
strength and function after chronic incomplete tetraplegia," said ONWARD Medical
co-founders Grégoire Courtine, PhD, Professor of Neuroscience and
Neurotechnology at the Swiss Federal Institute of Technology Lausanne (EPFL),
and Jocelyne Bloch, MD, Head of Functional Neurosurgery at Lausanne University
Hospital and Professor of Neurosurgery at EPFL. "We commend the outstanding
researchers and study participants who contributed to this seminal trial."
ARC-EX Therapy is external, programmed electrical stimulation that targets the
spinal cord non-invasively and is designed to aid in functional recovery after
SCI. The Up-LIFT study was a prospective, single-arm pivotal study designed to
evaluate the safety and effectiveness of the ARC-EX System to treat upper
extremity functional deficits in people with chronic tetraplegia. The global
study was conducted with 65 participants at 14 leading SCI centers in the United
States, Europe, and Canada.
At the end of Q1, ONWARD Medical submitted a De Novo application to the US Food
and Drug Administration (https://ir.onwd.com/static-files/a5157554-290f-4023-
bbc3-52ccda67cc4e) for market clearance of the ARC-EX System. The Company plans
to follow the US application with an application for market approval in Europe.
On Thursday, May 23(rd) at 2:30pm CET/8:30am ET following a brief Q1 Business
Update, CEO Dave Marver will host a discussion of Up-LIFT pivotal trial results
with a panel of principal investigators and study participants.
To join the webcast via Zoom, please register using this link (https://onwd.zoom.us/webinar/register/WN_XauQicu-QLCMZJISJPAJlg).
Participants may also join by phone:
+32 2 290 9360 (Belgium)
+33 1 7037 2246 (France)
+49 69 3807 9884 (Germany)
+31 20 794 0854 (Netherlands)
+41 22 591 0156 (Switzerland)
+44 203 481 5240 (United Kingdom)
+1 346 248 7799 (US)
Additional telephone numbers available
Meeting ID: 879 5741 2479
A recording of the webcast will be available on the Company's website following the live event.
Note: 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 scientific discovery,
preclinical, and clinical research conducted at leading hospitals,
rehabilitation clinics, and neuroscience laboratories, the Company has developed
ARC Therapy(TM), 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(TM) 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 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 (mailto:media@onwd.com)
For Investor Inquiries:
Amori Fraser, Finance Director
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.
_________________________________
* 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.
(1) Feingold-Polak, Ronit, et al. "The effects of an object's height and weight
on force calibration and kinematics when post-stroke and healthy individuals
reach and grasp." Scientific Reports. 2021.
(2) Smaby, Niels, et al. "Identification of key pinch forces required to
complete functional tasks." Journal of Rehabilitation Research & Development.
2004.
(3) Anderson, KD. "Targeting recovery: priorities of the spinal cord-injured
population." Journal of Neurotrauma. 2004.
A photo accompanying this announcement is available at
https://www.globenewswire.com/NewsRoom/AttachmentNg/c9a3a475-7e21-41aa-ad6d-
ea15e8cc7dae
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