THIS PRESS RELEASE CONTAINS INSIDE INFORMATION WITHIN THE MEANING OF ARTICLE
7(1) OF THE EUROPEAN MARKET ABUSE REGULATION (596/2014)
Company expects to commercialize its ARC-EX(®) System and commence the Empower
BP Pivotal Study for the ARC-IM(®) System in 2024
Company ended 2023 with EUR 29.8M in cash; Q4 cash burn was EUR 7M; cash runway
guidance reaffirmed through year-end 2024
Company reaffirms guidance and is highly confident the FDA submission for its
ARC-EX System will occur in 1H 2024
Company expects to advance clinical and development activities for its unique
ARC-BCITM brain-computer interface therapy
EINDHOVEN, the Netherlands, March 15, 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 previous cash guidance, shares its strategic priorities for 2024, and releases its unaudited Q4 financial highlights.
2024 Strategic Priorities
* ARC-EX commercial launch.?The Company expects to launch its investigational
ARC-EX Therapy to improve the strength and function of the upper extremities

    after SCI in the US in Q4 2024. Major associated milestones this year
    include FDA De Novo submission, FDA clearance, and first commercial sale.
  * ARC-IM pivotal study commencement.?The Company intends to launch its global
    pivotal study, called Empower BP, for investigational ARC-IM Therapy to
    address blood pressure instability after spinal cord injury. Major

associated milestones this year 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 and the recently announced FDA Breakthrough Device Designation and acceptance into the FDA's new TAP program.
Q4 Unaudited Financial Highlights

  * The Company plans to publish its Full Year 2023 financial statements on
    April 25, 2024.
  * The preliminary unaudited cash and cash equivalent balance on December
    31, 2023 was EUR 29.8 million.
  * Net cash outflow in Q4, 2023 was EUR 7.0 million, consistent with the EUR
    7.0M cash burn in Q3, 2023.
  * The Company confirms its previous guidance of expected cash runway through
    the end of 2024 and will look for efficient ways to strengthen its balance
    sheet in the coming months.

"We made robust progress in 2023, achieving important clinical milestones,
spending capital wisely, and preparing for regulatory submission of our first
therapy," said Dave Marver, CEO of ONWARD Medical. "In 2024, our focus is
commercialization -- we look forward to bringing the SCI Community the first-
ever therapy that can improve strength and function even years after a spinal
cord injury."
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(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 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(TM) 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 (mailto:media@onwd.com)?
For Investor Enquiries:?
Khaled Bahi, Interim CFO ?
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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