ONWARD® Medical Reaffirms 2024 Strategic Priorities and Releases
Unaudited Q2 Financial Highlights
Company expects to commercialize the
investigational ARC-EX® System in Q4
2024 and has commenced launch preparations
Company preparing to initiate global pivotal
trial for investigational ARC-IM®
Therapy to address blood pressure instability after spinal cord
injury
Company expects to advance clinical and
development activities for its unique
ARC-BCI™ brain-computer interface
therapy
EINDHOVEN, the Netherlands, Aug. 05, 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 reaffirms its 2024 strategic
priorities and releases its unaudited Q2 financial highlights.
2024 Strategic Priorities
ARC-EX commercial launch. The Company
expects to launch its ARC-EX Therapy for people with SCI in the US
in Q4 2024, pending FDA clearance. Accordingly, the Company has
accelerated launch preparations and continues to hire and develop
its field sales and service organization. More detail about its
launch plans will be provided during the 1H 2024 Investor Webinar
on 10 September 2024.
ARC-EX System pricing. Based on the strength of
the Up-LIFT pivotal study data published in Nature
Medicine in June 2024, the Company plans to price the ARC-EX
System at $40,000.
ARC-IM interim data publication. The Company
expects a peer-reviewed publication in a top-tier medical journal
detailing the results of the first 10+ patients implanted with
investigational ARC-IM Therapy to address blood pressure
instability after SCI.
ARC-IM pivotal study commencement. The
Company prepares to launch its global pivotal study, called Empower
BP, for ARC-IM Therapy to address blood pressure instability after
SCI. Major associated milestones expected to occur in Q4 2024 and
Q1 2025 include FDA IDE submission, FDA IDE approval, and first
participant enrollment.
ARC-BCI therapy advancement. The Company plans
to advance clinical and development activities for its
investigational ARC-BCI System, leveraging grant funding,
previously announced FDA Breakthrough Device Designation, and
acceptance into the new FDA new Total Product Life Cycle Advisory
Program (TAP). Several additional ARC-BCI System implants are
expected in 2H 2024 and 1H 2025 as part of the ongoing clinical
feasibility study with partners at .NeuroRestore and
CEA-Clinatec.
Q2 Unaudited Financial Highlights
- The net cash balance on June 30,
2024 was EUR 32.1 million.
- Company plans to publish its Half
Year 2024 financial statements and host an investor webinar focused
on commercial launch plans for the ARC-EX System on September 10,
2024.
“We are preparing to launch the ARC-EX System in Q4 in the US.
The strength of the Up-LIFT pivotal trial data published in
Nature Medicine supports a system price of $40,000,” said
Dave Marver, CEO of ONWARD Medical. “In addition to this important
first commercial launch, the coming quarters promise many
significant milestones and developments, including major
publications, study initiations, and clinical advancements.”
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.
*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 scientific discovery,
preclinical, and clinical research conducted at leading hospitals,
rehabilitation clinics, and neuroscience laboratories, the Company
has developed ARC Therapy™, 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™ 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
For Investor Inquiries:
Amori Fraser, Finance Director
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™ 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 8 2024 まで 9 2024
Onward Medical NV (EU:ONWD)
過去 株価チャート
から 9 2023 まで 9 2024