ONWARD Medical N.V. (Euronext: ONWD) (the “Company” or “ONWARD
Medical”), the medical technology company creating innovative
spinal cord stimulation therapies to restore movement, function,
and independence in people with spinal cord injury (SCI), announces
today that it has published a prospectus for the admission to
listing of 10 million ordinary shares in the Company’s share
capital, with a nominal value of EUR 0.12 each, issued through a
private placement with institutional investors, for which pricing
and allocation has occurred prior to trading on October 24, 2024
(the “Private Placement”). In connection with the listing of the
shares placed in the Private Placement, the Company published a
listing prospectus today. The prospectus was approved by the
Netherlands Authority for the Financial Markets (AFM) on October
24, 2024 and can be downloaded via
ir.onwd.com/shareholder-information.
This press release does not constitute, contain, or form part of
an offering of securities in any jurisdiction.
Note: 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
Paris, Brussels and Amsterdam (ticker: ONWD).
For more information, visit ONWD.com and connect with us on
LinkedIn and YouTube.
For Company Enquiries: info@onwd.com
For Media Enquiries:Aditi Roy, VP
Communicationsmedia@onwd.com
For Investor Enquiries:Amori Fraser, Finance
Directorinvestors@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,
delays in regulatory approvals, 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.
Additional important information
These materials may not be published, distributed or transmitted
in the United States, Canada, Australia or Japan. These materials
do not contain, constitute or form part of an offer of securities
for sale or a solicitation of an offer to purchase securities (the
“Securities”) of ONWARD Medical N.V. (the “Company”), in the United
States, Australia, Canada, Japan or any other jurisdiction in which
such offer or solicitation is unlawful. The Securities of the
Company may not be offered or sold in the United States absent
registration or an exemption from registration under the U.S.
Securities Act of 1933, as amended (the “Securities Act”). There
will be and has been no public offering of the Securities in the
United States. The Securities of the Company have not been, and
will not be, registered under the Securities Act. The Securities
referred to herein may not be offered or sold in Australia, Canada
or Japan or to, or for the account or benefit of, any national,
resident or citizen of Australia, Canada or Japan subject to
certain exceptions.
This document (and the information contained within) is an
advertisement and not a prospectus within the meaning of the
Regulation (EU) 2017/1129 in each member state (“Member State”) of
the European Economic Area (the “Prospectus Regulation”). The
Company has not authorised any offer to the public of Securities in
any Member State of the European Economic Area. With respect to
each Member State (each, a “Relevant State”), no action has been
undertaken or will be undertaken to make an offer to the public of
securities requiring publication of a prospectus in any Relevant
State. As a result, the Securities may and will only be offered in
Relevant States (i) to any legal entity, which is a “qualified
investor”, as defined in the Prospectus Regulation; or (ii) in any
other circumstances falling within Article 1(4) of the Prospectus
Regulation. For the purpose of this paragraph, the expression
"offer of securities to the public" means the communication in any
form and by any means of sufficient information on the terms of the
offer and the Securities to be offered so as to enable the investor
to decide to exercise, purchase or subscribe for the
Securities.
This document (and the information contained within) is an
advertisement and not a prospectus within the meaning of Regulation
(EU) 2017/1129, as it forms part of U.K. domestic law by virtue of
the European Union (Withdrawal) Act 2018 (the “U.K. Prospectus
Regulation”). No action has been undertaken or will be undertaken
that constitutes an offer of the securities referred to herein to
the public in the United Kingdom or requires the publication of a
prospectus in the United Kingdom. The securities referred to herein
may not and will not be offered in the United Kingdom, except to
relevant persons in accordance with the exemptions set forth in the
U.K. Prospectus Regulation.
In the United Kingdom, this document is only being distributed
to and is only directed at “qualified investors” within the meaning
of the U.K. Prospectus Regulation, and who are also (i) investment
professionals falling within Article 19(5) of the Financial
Services and Markets Act 2000 (Financial Promotion) Order 2005 (as
amended, the "Financial Promotion Order"), (ii) high net worth
entities or other persons falling within Article 49(2)(a) to (d) of
the Financial Promotion Order or (iii) persons to whom an
invitation or inducement to engage in investment activity (within
the meaning of section 21 of the Financial Services and Markets Act
2000 (as amended)) in connection with the issue or sale of any
securities may otherwise lawfully be communicated or caused to be
communicated (all such persons being referred to as “Relevant
Persons”).. This document is directed only at Relevant Persons and
must not be acted on or relied on by persons who are not Relevant
Persons. Any investment or investment activity to which this
document relates is available only to Relevant Persons and will be
engaged in only with Relevant Persons.
This communication is not a prospectus for the purposes of the
Prospectus Regulation. This communication cannot be used as basis
for any investment agreement or decision. Acquiring investments to
which this announcement relates may expose an investor to a
significant risk of losing the entire amount invested. Persons
considering making such investments should consult an authorised
person specialising in advising on such investments. This
announcement does not constitute a recommendation concerning the
securities referred to herein.
No announcement or information regarding the offering, listing
or securities of the Company referred to above may be disseminated
to the public in jurisdictions where a prior registration or
approval is required for such purpose. No steps have been taken, or
will be taken, for the offering or listing of securities of the
Company in any jurisdiction where such steps would be required,
except for the admission of the offered shares on the regulated
market of Euronext Brussels, Euronext Amsterdam and Euronext Paris.
The issue, exercise, or sale of, and the subscription for or
purchase of, securities of the Company are subject to special legal
or statutory restrictions in certain jurisdictions. The Company is
not liable if the aforementioned restrictions are not complied with
by any person.
Information to Distributors
Manufacturer Target Market (MiFID II/UK MIFIR Product
Governance): Professional clients and eligible
counterparties only.
Notwithstanding the Target Market Assessment, distributors
should note that: the price of the offered shares may decline and
investors could lose all or part of their investment; the offered
shares offer no guaranteed income and no capital protection; and an
investment in the offered shares is compatible only with investors
who do not need a guaranteed income or capital protection, who
(either alone or in conjunction with an appropriate financial or
other adviser) are capable of evaluating the merits and risks of
such an investment and who have sufficient resources to be able to
bear any losses that may result therefrom. The Target Market
Assessment is without prejudice to the requirements of any
contractual, legal or regulatory selling restrictions in relation
to the Private Placement. Furthermore, it is noted that,
notwithstanding the Target Market Assessment, the placement agents
in the Private Placement will only procure investors who meet the
criteria of professional clients and eligible counterparties.
For the avoidance of doubt, the Target Market Assessment does
not constitute: (a) an assessment of suitability or appropriateness
for the purposes of MiFID II; or (b) a recommendation to any
investor or group of investors to invest in, or purchase, or take
any other action whatsoever with respect to the offered shares.
Each distributor is responsible for undertaking its own target
market assessment in respect of the offered shares and determining
appropriate distribution channels.
UBS, Bryan, Garnier & Co, Degroof Petercam, and KBC
Securities acted exclusively for the Company and no one else in
connection with the Private Placement. In connection with such
matters, they, their affiliates and their respective directors,
officers, employees and agents will not regard any other person as
their client, nor will they be responsible to any other person for
providing the protections afforded to their clients or for
providing advice in relation to the Private Placement or any other
matters referred to in this announcement.
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