ONWARD® Medical Awarded 10th Breakthrough Device Designation for Brain-Computer Interface (BCI) from US FDA
29 Février 2024 - 7:41AM
UK Regulatory
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™ 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™, 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™ 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
For Investor Enquiries:
Khaled Bahi, Interim CFO
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™, are investigational and not available for commercial
use.
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