Nature Medicine published Up-LIFT pivotal trial results

             Submitted FDA De Novo application for ARC-EX(®) System
                 Successfully raised EUR 20M in equity capital
EINDHOVEN, the Netherlands, May 23, 2024 (GLOBE NEWSWIRE) --  ONWARD Medical

N.V. (Euronext: ONWD), a medical technology company creating innovative spinal
cord stimulation therapies to restore movement, function, and independence in
people with spinal cord injury (SCI), today provided a Q1 2024 business update.
"This week's publication of Up-LIFT pivotal trial results in Nature Medicine
underscores the tremendous potential of ARC-EX Therapy to restore independence
in daily activities for people with spinal cord injury," said Dave Marver, CEO
of ONWARD Medical. "We are working closely with the FDA toward clearance for the
ARC-EX System and we are preparing to introduce this technology to the SCI
Community in the US later this year."
Q1 and Year-To-Date Highlights:
Clinical and Development

  * In January 2024, the Company expanded its HemON clinical feasibility study
    to explore use of the ARC-IM System to improve blood pressure regulation

after SCI with the addition of Sint Maartenskliniek in the Netherlands. This

    additional research site prepares the Company for expected Q4 2024
    initiation of a global pivotal trial called Empower BP to assess the safety
    and efficacy of ARC-IM Therapy to improve blood pressure regulation.
  * In February 2023, the Company announced it has been awarded Breakthrough
    Device Designation (BDD) by the US Food and Drug Administration (FDA) for
    the ARC-BCI(TM) System, which uses brain-computer interface (BCI) technology in
    conjunction with its ARC-IM Therapy to restore thought-driven lower limb
    mobility after spinal cord injury (SCI). This is the Company's tenth BDD.
  * In March 2024, ONWARD Medical was only the second BCI company admitted into
    the FDA's new Total Product Lifecycle Advisory Program (TAP).
  * In April 2024, the Company announced it had submitted a De Novo application
    to the US FDA to obtain regulatory clearance to begin marketing its non-
    invasive ARC-EX System in the United States. Clearance is expected Q4 2024.

* In May 2024, the Company announced the publication of global Up-LIFT pivotal

    trial results in Nature Medicine. The study achieved all primary and
    secondary safety and effectiveness endpoints, and ARC-EX Therapy
    demonstrated significant improvements in upper limb strength, function, and
    sensation among people with chronic tetraplegia due to cervical SCI.

Intellectual Property

  * The Company was issued 13 new patents during Q1 2024, bringing its total
    number of issued patents year-to-date to more than 265, further
    strengthening its first-mover advantage.

Corporate and Financial

  * In March 2024, the Company completed a EUR 20M equity financing that
    strengthened its cash position to support investments in product
    development, clinical trials, operational and commercial capabilities; this
    financing extended the Company's cash runway through mid-2025.

* The Company reported cash and cash equivalents of EUR 42 million as of March 31, 2024.
Outlook:
ONWARD Medical expects steady and consistent execution to continue throughout
2024 with planned achievement of the following target milestones:

  * The Company expects FDA clearance and first commercial sale in the US for
    its ARC-EX System sometime in Q4 2024. European regulatory approval and
    commercialization are expected sometime in 2025.
  * The Company continues to prepare for its Empower BP global pivotal trial to
    evaluate the safety and effectiveness of its implantable ARC-IM System to
    address blood pressure instability after SCI. It expects IDE approval from
    FDA in Q4 2024 to commence this study. First participant enrollment could
    occur in late 2024 or early 2025. The Company also expects publication of
    interim results from clinical feasibility studies for this indication in a
    leading scientific journal sometime in 2H 2024.

* The Company expects to gain additional clinical data and experience with its

    implantable ARC-IM System in 2024, with several implants planned with
    support from the Michael J. Fox Foundation for Parkinson's Research as well
    as several more planned in combination with an investigational brain-
    computer interface (BCI) with support from the European Innovation Council.
  * The Company reaffirmed its expected cash runway through mid-2025 and will
    opportunistically evaluate measures to further strengthen its balance sheet
    in the coming months.

Conference Call & Webcast
ONWARD Medical will host a conference call with a live webcast today, May
23, 2024, at 2:30 pm CET / 8:30 am ET. The webcast, which includes a discussion
of Up-LIFT pivotal trial results with a panel of company leaders, study
principal investigators, and study participants, may be accessed on the
Financial Information (https://ir.onwd.com/financial-information) page of the
Company's website. A replay of the webcast also will be available on the ONWARD
Medical investor website.
To join the webcast via Zoom, please register using this link
(https://onwd.zoom.us/webinar/register/WN_XauQicu-QLCMZJISJPAJlg#/registration).
*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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