EINDHOVEN, the Netherlands, Feb. 29, 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 it has been awarded Breakthrough Device Designation (BDD) by the US Food and Drug Administration (FDA) for the ARC-BCI System, which uses brain-computer interface (BCI) technology in conjunction with its ARC-IM® Therapy to restore thought-driven lower limb mobility after spinal cord injury (SCI). This BDD is supported by clinical data from two feasibility studies.
This is the tenth FDA BDD awarded to ONWARD Medical. The designation is reserved
for novel, cutting-edge therapies addressing an unmet need and provides many
potential regulatory and reimbursement advantages. This latest award gives
ONWARD Medical priority FDA review, the opportunity to interact with FDA experts
throughout the pre-market regulatory review phase, and the potential to seek
additional reimbursement for its ARC-BCI System.
"Brain-computer interface technology unlocks the transformative potential to
enhance ARC-IM with thought-driven control of movement after paralysis," said
ONWARD Medical CEO Dave Marver. "We look forward to learning more about the
potential for this combination of ARC Therapy(TM) and a BCI to help people with
spinal cord injury live more independently. We are also grateful to the FDA for
recognizing our innovations and their potential to help people with profound
unmet needs."
An implanted BCI records brain activity, capturing signals that indicate a
person's intention to move. The ARC-BCI System then uses artificial intelligence
(AI) to decode those signals and translate them into specific instructions for
the ARC-IM System, which converts the instructions into precise stimulation of
the injured spinal cord. ARC-BCI creates a "digital bridge," restoring
communication between the brain and the body, enabling thought-driven movement
after paralysis.
In 2021, a BCI was paired with ARC-IM Therapy for the first time in history to
restore movement of the lower limbs, including walking, after SCI. In May 2023,
Nature published the results of this groundbreaking feasibility study,
highlighting the study participant's augmented control over his paralyzed legs
with the addition of a BCI. ONWARD Medical was previously granted nine BDDs for
multiple indications for its ARC Therapy platforms, including mobility and blood
pressure regulation. The Company plans to launch its first product later this
year.
All ONWARD Medical devices and therapies, including but not limited to ARC-IM®,
ARC-EX®, 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 science and preclinical
research conducted at leading neuroscience laboratories, the Company has
received ten Breakthrough Device Designations from the US Food and Drug
Administration for its ARC Therapy(TM) platform.
ONWARD® ARC Therapy, which can be delivered by external ARC-EX® or implantable
ARC-IM® platforms, 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 instability, following SCI. Other ongoing
studies include combination use of ARC-IM with a brain-computer interface (BCI)
to address multiple symptoms of 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 also has an academic partnership with .NeuroRestore,
a collaboration between the Swiss Federal Institute of Technology (EPFL), and
Lausanne University Hospital (CHUV).
ONWARD Medical 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 Enquiries:??
Aditi Roy, VP Communications?
media@onwd.com (mailto:media@onwd.com)?
For Investor Enquiries:?
Khaled Bahi, Interim CFO ?
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®, and ARC Therapy(TM), are investigational and not
available for commercial use.
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