EINDHOVEN, the Netherlands, Jan. 25, 2024 (GLOBE
NEWSWIRE) -- ONWARD Medical N.V. (Euronext: ONWD), the medical
technology company creating innovative therapies to restore
movement, function, and independence in people with spinal cord
injury (SCI), today announced that clinical experience, results,
and therapy programming strategies from clinical studies, including
the Up-LIFT pivotal study, were presented during the NANS 2024
meeting in Las Vegas, Nevada, USA. The Up-LIFT pivotal study
investigated non-invasive neuromodulation to improve upper
extremity strength and function after SCI; ARC-EX Therapy met all
primary safety and effectiveness endpoints and demonstrated a 72%
responder rate1.
During the Neuromodulation for
Spinal Cord Injury (SCI) main stage presentation, Dr. David
Darrow, Neurosurgeon and Assistant Professor at the University of
Minnesota, Dr. Claudia Angeli PhD, Assistant Director of Kessler
Foundation, and Dr. James Guest, Neurosurgeon and Professor of
Neurological Surgery at the University of Miami and the Miami
Project to Cure Paralysis, discussed SCI-targeted innovations.
While bringing awareness to spinal cord injury during a meeting
traditionally focused on chronic pain and movement disorders, Dr.
Guest presented clinical results and his experience from the
Up-LIFT pivotal study.
Neurosurgeon Dr. James
Guest discusses investigational ARC-EX
Therapy for functional recovery of upper
extremities after SCI on the main stage at NANS
2024
The ARC-EX System, which received
Breakthrough Device Designation from the US Food & Drug
Administration in 2017 for improved upper limb function, is
designed to non-invasively deliver electrical stimulation to the
spinal cord.
“We are pleased to see our innovative
therapies garner attention on the main stage at NANS, an important
society and stakeholder group whose membership will drive access
and adoption for ARC Therapy in North America,” said Dave Marver,
ONWARD CEO. “We are preparing to submit a De Novo application for
ARC-EX Therapy to FDA in the near future, leveraging the positive
clinical results from the Up-LIFT pivotal study.”
The Company’s ARC-EX Therapy was also
highlighted in two abstracts accepted by the NANS scientific board,
including Transcutaneous Spinal Cord Stimulation Facilitates
Upper Extremity Functional Recovery in Spinal Cord Injury: Results
From The Up-LIFT Pivotal Trial (James Guest MD, PhD, Edelle C
Field-Fote PT, PhD, Candace Tefertiller DPT, PhD, et al.) and
Transcutaneous Spinal Cord Stimulation Parameters and
Programming Strategies for Effective Upper Extremity Rehabilitation
Following Tetraplegia (Chet Moritz PhD, Edelle C
Field-Fote PT, PhD, Ilse van Nes MD, PhD, et al.).
All ONWARD devices and therapies,
including but not limited to ARC-IM®, ARC-EX,
and ARC Therapy, alone or in combination with BCI,
are investigational and not available for commercial
use.
1 Responder defined as a participant who met or
exceeded the minimally important difference criteria for at least
one outcome of the strength domain and at least one outcome of the
functional performance domain.
About ONWARD
Medical
ONWARD 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 nine 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 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).
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 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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