Framework to determine stimulation parameters for ONWARD ARC-EX Therapy are

  published in the journal Neuromodulation: Technology at the Neural Interface
  Peer-reviewed publication is based on results from the Up-LIFT and LIFT Home
                                    studies

EINDHOVEN, the Netherlands, July 09, 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 a publication in
Neuromodulation: Technology at the Neural Interface
(https://www.sciencedirect.com/science/article/pii/S1094715924001119),
summarizing effective stimulation parameters from the Up-LIFT and LIFT Home
studies and providing a decision-making framework for clinical implementation of
ONWARD ARC-EX Therapy created by study investigators.
Investigational ARC-EX Therapy is non-invasive, programmed spinal cord
stimulation designed to improve upper limb function after incomplete cervical
SCI. The publication in Neuromodulation: Technology at the Neural Interface
provides an evidence-based framework to determine stimulation parameters for
ARC-EX Therapy based on analysis of device parameters, usage data, and clinician
and participant feedback from the Up-LIFT pivotal trial and follow-on LIFT Home
study.
The Neuromodulation publication references observations and results from the Up-
LIFT pivotal trial, which were published in May 2024 in Nature Medicine
(https://www.nature.com/articles/s41591-024-02940-9), and which demonstrated
significant improvement in hand and arm function after SCI with use of ARC-EX
Therapy. At the end of the trial, 72% of participants were considered responders
to non-invasive ARC-EX Therapy* based on a responder definition for participants
to meet improvement criteria in both strength and functional domains. Notably,
the number of responders increased to 90% when the definition included
participants with improvements in at least one strength or functional outcome*
and 87% of participants reported improvements in quality of life with ARC-EX
Therapy*. There were no serious device-related adverse events observed during
either the Up-LIFT trial or LIFT Home study.
Up-LIFT and Lift Home study investigators recognized the importance of
simplifying programming processes for their peers. "We are very excited to share
the insights we gained through the first large-scale study of transcutaneous
spinal stimulation with clinicians" said Chet Moritz, PhD, co-Principal
Investigator of the Up-LIFT trial, publication co-author, and Professor of
Electrical & Computer Engineering and Rehabilitation Medicine at the University
of Washington. "These programming insights were developed based on our
experience with 60 participants in the Up-LIFT trial, and we expect them to be
very helpful in determining the optimal parameters for stimulation for a wide
range of patients in the clinic."
To learn more about ONWARD Medical's commitment to partnering with the SCI
Community to develop innovative solutions for restoring movement, function, and
independence after spinal cord injury, please visit ONWD.com
(https://www.onwd.com/).
*Moritz, Chet, et al. "Non-invasive spinal cord stimulation for arm and hand
function in chronic tetraplegia: a safety and efficacy trial." Nature Medicine.
2024.
Note: Unless otherwise noted, statements herein are based on the publication
discussed: Gelenitis, Kristen, et al. "Non-invasive Transcutaneous Spinal Cord
Stimulation Programming Recommendations for the Treatment of Upper Extremity
Impairment in Tetraplegia" Neuromodulation. 2024.
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 scientific discovery,
preclinical, and clinical research conducted at leading hospitals,
rehabilitation clinics, and neuroscience laboratories, the Company has developed
ARC Therapy(TM), which has been awarded ten Breakthrough Device Designations from
the US Food and Drug Administration (FDA).
ONWARD ARC Therapy is targeted, programmed spinal cord stimulation designed to
be delivered by the Company's external ARC-EX(®) or implantable ARC-IM(®)
platforms. ARC Therapy can also be delivered by the Company's ARC-BCI(TM) platform,
which pairs the ARC-IM System with brain-computer interface (BCI) technology to
restore movement after SCI with thought-driven control.
Use of non-invasive ARC-EX Therapy significantly improved upper limb function
after SCI in the global pivotal Up-LIFT trial, with results published by Nature
Medicine in May 2024. The Company has submitted its regulatory application to
the FDA for clearance of the ARC-EX System in the US and is preparing for
regulatory submission in Europe. In parallel, the Company is conducting clinical
studies with its ARC-IM Therapy, which demonstrated positive interim clinical
outcomes for improved blood pressure regulation following SCI. Other ongoing
clinical studies focus on using ARC-IM Therapy to address mobility after SCI and
gait challenges in Parkinson's disease as well as using the ARC-BCI platform to
restore thought-driven movement of both upper and lower limbs after 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 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 Inquiries:
Aditi Roy, VP Communications
media@onwd.com (mailto:media@onwd.com)
For Investor Inquiries:
Amori Fraser, Finance Director
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-BCI(TM) and ARC Therapy(TM), are
investigational and not available for commercial use.
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