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 a publication in Nature Medicine
using investigational ONWARD ARC Therapy to address gait challenges
related to Parkinson’s disease.
The study participant described in the Nature
Medicine publication has been living with Parkinson’s disease for
nearly three decades. He has a severe gait disorder that has not
responded to conventional therapies.
"I could hardly walk without frequent falls,
several times a day. In certain situations, like getting into an
elevator, I would stomp, freeze as they say,” said the study
participant in a press release issued by Switzerland’s Lausanne
University Hospital (CHUV).
In 2021, researchers from the Swiss Federal
Institute of Technology (EPFL) and CHUV investigated the
possibility that ONWARD ARC Therapy (precise, targeted electrical
stimulation of the spinal cord) could address common side effects
of Parkinson’s disease that negatively impact mobility. The team
collaborated with Dr. Erwan Bezard, a renowned neuroscientist from
France’s National Institute of Health and Medical Research
(INSERM).
After the introduction of ARC Therapy and
benefitting from a few weeks of rehabilitation, the study
participant was able to walk without previously noticeable gait
interruptions. Today, he uses ARC Therapy eight hours per day.
"I turn on the stimulation in the morning and
turn it off in the evening. It allows me to walk better, to
stabilize myself. Even stairs don't scare me anymore. Every Sunday
I go to the lake, and I walk about six kilometers. It's awesome,"
said the participant in the CHUV release.
“The breakthrough reported in Nature
Medicine shows the remarkable potential to use the same
technology platform and therapy we are developing for spinal cord
injury to also address mobility challenges stemming from
Parkinson’s disease,” says Dave Marver, CEO of ONWARD.
"It is impressive to see that by electrically
stimulating the spinal cord the same way we have done in paraplegic
patients, we may be able to address gait disorders due to
Parkinson's disease," adds neurosurgeon Jocelyne Bloch, co-director
with Professor G. Courtine of ONWARD research partner
.NeuroRestore.
.NeuroRestore was awarded a $1 million grant
from The Michael J. Fox Foundation for Parkinson’s Research (MJFF)
to implant the ARC-IM System and investigate the effect of ARC
Therapy in six additional participants with Parkinson’s disease.
This study will assist ONWARD in determining whether to conduct
additional clinical trials and potentially commercialize ARC
Therapy in the future for those living with Parkinson’s
disease.
“MJFF is committed to fulfilling the unmet needs
of people living with Parkinson’s disease by ensuring the
development of improved therapies,” said Katharina Klapper,
Director of Clinical Research, MJFF. “The Foundation is pleased to
award a grant for scientists at EPFL and ONWARD Medical to
investigate the effects of ARC Therapy in people with experiencing
gait challenges.”
All ONWARD devices and therapies, including but
not limited to ARC-IM, ARC-EX, and ARC Therapy, are investigational
and not available for commercial use.
Note: ONWARD has previously disclosed
achievement of human proof-of-concept for Parkinson’s disease in
its Company Presentation.
About ONWARD Medical
ONWARD 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 nine
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 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 stability following SCI.
Other ongoing studies include combination use of ARC-IM with a
brain-computer interface (BCI).
Headquartered in Eindhoven, the Netherlands,
ONWARD 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).
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, CFO
investors@onwd.com DisclaimerCertain 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 devices and therapies referenced here,
including but not limited to ARC-IM, ARC-EX, and ARC Therapy, are
investigational and not available for commercial use.
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