ONWARD® Medical Announces Third Implant of Brain-Computer Interface
(BCI) System to Restore Movement after Spinal Cord Injury
Company continues pioneering research on BCI-enabled
system to restore mobility after spinal cord injury
EINDHOVEN, The Netherlands, Sept. 19, 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), announces another successful implant
of its investigational ARC-BCI™ System to restore lower
limb mobility after SCI.
The ARC-BCI System combines the investigational ONWARD
ARC-IM® System (an implanted technology that delivers
targeted stimulation to the spinal cord) with the investigational
WIMAGINE® BCI from CEA-Clinatec to create a
DigitalBridge™ across the injured spinal cord. The
implant procedure was performed on September 12, 2024, by Jocelyne
Bloch, MD, head of functional neurosurgery at Centre Hospitalier
Universitaire Vaudois (CHUV) in Lausanne, Switzerland.
“The procedure went smoothly, and early signs are encouraging,”
said neurosurgeon Dr. Jocelyne Bloch. “We look forward to sharing
more information in the coming months as the participant progresses
in their rehabilitation and we publish observations from the
study.”
This implant is part of an ongoing clinical feasibility study
supported by a grant from the European Innovation Council under the
Reverse Paralysis project and coordinated by .NeuroRestore, a Swiss
neuroscience research institute. The researchers are also exploring
use of the ONWARD ARC-BCI System to address upper limb movement
challenges after SCI in a separate early feasibility clinical study
funded by the Christopher & Dana Reeve Foundation.
The WIMAGINE BCI from CEA-Clinatec is an epidurally-implanted
device with 7 years of human safety data; ONWARD ARC-IM Therapy has
now been applied in more than 30 study participants.
“While other companies race to develop BCIs to communicate with
and control computers, ONWARD Medical stands alone in our
commitment to exploring the potential for this promising technology
to restore movement of the human body after paralysis,” said Dave
Marver, CEO of ONWARD Medical. “We salute our brilliant partners at
CEA-Clinatec and .NeuroRestore for their important contributions to
this research.”
This latest news marks the third human implant of the WIMAGINE
BCI paired with ARC-IM Therapy to restore thought-enabled movement
after SCI and the second for lower limb mobility. The first human
use of ARC-BCI Therapy for lower limb mobility occurred in 2021,
with results describing the individual’s augmented control over
when and how he moved his paralyzed legs published in
Nature in May 2023. In the fall of 2023, an individual was
implanted to explore the potential for ARC-BCI Therapy to restore
upper extremity function after SCI.
Earlier this year, the Company announced that it has been
accepted into the US FDA’s new Total Product Lifecycle Advisory
Program (TAP) for its ARC-BCI platform. Prior to the acceptance,
the Company announced its ARC-BCI System was awarded FDA
Breakthrough Device Designation (BDD), a requirement for TAP
consideration. This is the Company’s 10th such
award.
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.
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™, 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™ 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
For Investor Inquiries:
Amori Fraser, Finance Director
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,
delays in regulatory approvals, 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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