ONWARD® Announces Start of HemON NL Clinical Study
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 the start of the HemON NL
clinical feasibility study at Sint Maartenskliniek in Nijmegen, the
Netherlands.
In late 2023, a study
participant was implanted with an investigational ARC-IM
Neurostimulator and Lead to assess the safety and effectiveness of
ARC-IM Therapy to address hemodynamic instability after SCI. The
surgery was performed by neurosurgeon Erkan Kurt, MD at Radboud
University Medical Center, which has a neurosurgery department
affiliated with Sint Maartenskliniek.
Building on the Swiss
HemON clinical feasibility study, HemON NL prepares the Company for
expected initiation of a global pivotal trial, called Empower BP,
which is designed to provide the evidence necessary to submit a
pre-market approval (PMA) to the US Food and Drug Administration
(FDA) and other global regulatory authorities. In December 2022,
the Company announced positive interim clinical results from its
early feasibility studies showing improved regulation of blood
pressure, thereby improving hemodynamic stability, after
SCI.
The Company plans to
enroll participants in both HemON and HemON NL as it finalizes the
design of the Empower BP pivotal study.
“Sint Maartenskliniek
has long been an outstanding research partner, and we are delighted
to work with them on this new and exciting study to evaluate the
use of ARC-IM Therapy to stabilize disruptive and potentially
life-threatening fluctuations in blood pressure after SCI,” said
Dave Marver, CEO of ONWARD. “This is an important but
underappreciated recovery target after SCI. We hope this research
and the expected upcoming pivotal study will shine a light on the
importance of hemodynamic stability in this
population.”
Dr. Erkan Kurt, MD implants his first ARC-IM
Neurostimulator
The Principal
Investigator of the HemON NL study is Dr. Ilse van Nes, a leading
rehabilitation physician in the spinal cord injury department of
Sint Maartenskliniek.
“The procedure went
smoothly and the participant is responding well,” said Dr. van Nes.
We are excited to monitor this and additional patients’ ongoing
response to this groundbreaking therapy, which is designed to
deliver programmed electrical stimulation to the area of the spine
responsible for regulating blood pressure after
SCI.”
ONWARD has received
nine FDA Breakthrough Device Designations for its ARC-IM System,
one of them for hemodynamic instability after SCI, inclusive of
blood pressure regulation.
*All ONWARD devices
and therapies, including but not limited to ARC-IM, ARC-EX, and ARC
Therapy, alone or in combination with a BCI, are investigational
and not available for commercial use.
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.
Onward Medical NV (EU:ONWD)
過去 株価チャート
から 4 2024 まで 5 2024
Onward Medical NV (EU:ONWD)
過去 株価チャート
から 5 2023 まで 5 2024