EINDHOVEN, the Netherlands, March 11, 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 that it has been accepted into the US FDA's new Total Product Lifecycle Advisory Program (TAP) for its brain-computer interface (BCI) technology.
This acceptance follows ONWARD Medical's announcement last week that its
investigational ARC-BCI System was awarded FDA Breakthrough Device Designation
(BDD), a requirement for TAP consideration. ONWARD Medical is only the second
BCI company to be accepted into the program.
TAP provides ONWARD Medical with early and frequent strategic engagement from
the FDA, patients, providers, and payers to facilitate more rapid development
and widespread patient access to safe, effective, high-quality medical devices
of public health importance. As part of TAP, the Company benefits from more
timely premarket interactions, earlier identification and mitigation of device
development risk, and a more efficient premarket review process.
"We are honored to be one of the first BCI companies included in this important
program, which allows for the fastest FDA review times of new medical
technology," said ONWARD Medical CEO Dave Marver. "TAP enables us to reduce the
time and cost to deliver the benefits of ARC-BCI to people living with
paralysis."
The ONWARD ARC-BCI System pairs BCI technology with ARC-IM(®) Therapy to restore
mobility after spinal cord injury (SCI). To date, two clinical feasibility
studies support the potential of ARC-BCI, including one in 2021 and one in 2023
that restored lower and upper limb movement after SCI respectively. These were
the first studies in history in which a human regained thought-driven movement
of their limbs after paralysis.
*All ONWARD Medical devices and therapies, including but not limited to ARC-
IM(®), ARC-EX(®), ARC-BCI(TM), 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(®) 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, 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(®), ARC Therapy(TM), and ARC-BCI(TM) are
investigational and not available for commercial use.
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