ONWARD® Medical Accepted to New US FDA TAP Program for Development of its ARC-BCI™ System
11 Março 2024 - 3:30AM
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™,
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® 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
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®, ARC Therapy™,
and ARC-BCI™ are investigational and not available for commercial
use.
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