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 grant from the Christopher
& Dana Reeve Foundation to support expansion of an ongoing
early clinical feasibility study to explore the use of a
brain-computer interface (BCI) to restore thought-driven use of the
hands and arms after SCI.
The ongoing early feasibility clinical study is also supported
by the European Innovation Council under the Reverse Paralysis
project. The first study participant was implanted with the
investigational ARC-BCI System in August 2023. The Reeve
Foundation’s $1.1 million grant to study sponsor and ONWARD Medical
research partner, .NeuroRestore, enables up to four additional
participants to be implanted with the ONWARD ARC-BCI System.
.NeuroRestore is a collaboration between the Swiss Federal
Institute of Technology (EPFL) and Lausanne University Hospital
(CHUV) and key research partner to ONWARD Medical.
“While other companies are using BCI technology to interface
with computers, ONWARD is leading the pursuit of BCI-augmented
movement restoration,” said ONWARD Medical CEO Dave Marver. “We are
grateful to the Christopher & Dana Reeve Foundation for its
support, which enables us to expand this important study.”
“This grant reflects our vision to facilitate rapid scientific
advancement to address the unmet needs of individuals living with
SCI,” said Marco Baptista, Ph.D., Chief Scientific Officer of the
Christopher & Dana Reeve Foundation. “We look forward to
working with ONWARD Medical in learning more about the potential
for BCI technology to meet those challenges.”
The ARC-BCI System combines the investigational WIMAGINE® BCI
from CEA-Clinatec with investigational ONWARD ARC-IM® Therapy
(implanted targeted spinal cord stimulation) to form a
DigitalBridge™ that enables thought-driven movement restoration.
The WIMAGINE BCI is an epidural implant with 7 years of human
safety data and ONWARD ARC-IM Therapy has been applied in more than
30 study participants. ONWARD Medical is also investigating the use
of its ARC-BCI System to address lower limb mobility challenges
after SCI in a separate early feasibility clinical study.
The first-in-human use of ARC-IM Therapy paired with an
implanted BCI in a clinical study resulted in an individual gaining
augmented control over when and how he moved his paralyzed legs.
The results of this study were published in Nature in May 2023.
Earlier this year, ONWARD Medical announced that it was accepted
into the US FDA’s new Total Product Lifecycle Advisory Program
(TAP) for its ARC-BCI platform, which was also awarded FDA
Breakthrough Device Designation (BDD).
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
Directorinvestors@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™ and
ARC Therapy™, are investigational and not available for commercial
use.
Onward Medical NV (EU:ONWD)
過去 株価チャート
から 8 2024 まで 9 2024
Onward Medical NV (EU:ONWD)
過去 株価チャート
から 9 2023 まで 9 2024