ONWARD® Announces First-in-Human Implant of ARC-IM™ Stimulator with Brain-Computer Interface (BCI) to Restore Arm, Hand, and Finger Function after Spinal Cord Injury
27 Septiembre 2023 - 12:30AM
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 successful first-in-human
implant of its ARC-IM Stimulator*, to restore upper extremity
function after SCI. The patient also received a wireless
brain-computer interface (BCI), designed to initiate thought-driven
movement when paired with ARC-IM.
ONWARD ARC-IM delivers targeted, programmed
ARC-IM Therapy to the spinal cord to restore movement and other
functions after spinal cord injury. ARC-IM Therapy has been applied
across multiple clinical feasibility studies to restore mobility
and stabilize blood pressure after SCI. For the first time, ARC-IM
Therapy has now also been used to restore upper extremity movement
and function.
Two procedures were performed last month by
neurosurgeon Jocelyne Bloch, MD, at Centre Hospitalier
Universitaire Vaudois (CHUV) in Lausanne, Switzerland. The ARC-IM
implant procedure took place on August 14, 2023, and nine days
later the BCI WIMAGINE® from CEA-Clinatec was implanted.
Working in concert with ARC-IM, the BCI is
engineered to capture the intention of a paralyzed individual to
move their upper extremities and uses artificial intelligence to
decode those thoughts. ARC-IM then converts the decoded information
into ARC-IM Therapy - precise stimulation of the spinal cord -
resulting in thought-driven movement.
“The implant procedures involving the ONWARD
ARC-IM and Clinatec BCI went smoothly,” said Dr. Jocelyne Bloch.
“We are now working with the patient to use this cutting-edge
innovation to recover movement of his arms, hands, and fingers. We
look forward to sharing more information in due course.”
This latest breakthrough is part of an ongoing
clinical study investigating the safety and effectiveness of
thought-initiated spinal cord stimulation after SCI. It builds on
the ONWARD announcement from May 2023 that pairing its ARC Therapy
with a BCI implant resulted in an individual gaining augmented
control over movement of his paralyzed legs. The study is supported
by a grant from the European Innovation Council (Reverse Paralysis
project) and is coordinated by .NeuroRestore co-Directors –
Professor Grégoire Courtine and Dr. Jocelyne Bloch – as well as
Guillaume Charvet, head of the Medical Device Development Lab at
CEA-Clinatec.
“This is another impressive piece of research
from our partners at .NeuroRestore. We are excited to learn how
ARC-IM Therapy may restore upper extremity function after SCI, and
we are eager to see how the addition of a BCI might augment our
therapy,” said Dave Marver, CEO of ONWARD. “Congratulations to the
teams at EPFL, CHUV, and CEA-Clinatec for this breakthrough. We
feel privileged that our technology is part of this research.”
The Company expects to share more information
about this pioneering research in the coming months, concurrent
with a peer-reviewed publication describing the procedure and
results.
*All ONWARD devices and therapies, including but
not limited to ARC-IM™, ARC-EX™, and ARC Therapy™, alone or in
combination with a BCI, are investigational and not available for
commercial use.
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 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:Lara
Smith Weber, CFO Khaled Bahi, Interim CFO (as of October 1st,
2023)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 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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