NOT FOR DISTRIBUTION OR RELEASE, DIRECTLY OR INDIRECTLY, IN OR INTO THE UNITED STATES, CANADA, AUSTRALIA OR JAPAN OR ANY OTHER JURISDICTION IN WHICH THE DISTRIBUTION OR RELEASE WOULD BE UNLAWFUL. OTHER RESTRICTIONS ARE APPLICABLE. PLEASE SEE THE IMPORTANT NOTICE AT THE END OF THE PRESS RELEASE.
THIS PRESS RELEASE CONTAINS INSIDE INFORMATION WITHIN THE MEANING OF ARTICLE (7)(1) OF THE EUROPEAN MARKET ABUSE REGULATION (596/2014)
EINDHOVEN, the Netherlands, March 25, 2024 (GLOBE NEWSWIRE) -- 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) and movement disorders, announces today the closing of its previously announced private placement with institutional investors, certain founders, certain members of management, and certain members of the Board of Directors (the "Private Placement") and of its separate public offering via the PrimaryBid
platform with retail investors in France (the "Public Offer" and together with the Private Placement the "Offerings"). The gross proceeds from the Offerings amount to EUR20 million.
As of today, the new shares issued pursuant to the Offerings are admitted to
listing and trading on Euronext Brussels and Euronext Amsterdam.
This press release does not constitute, contain, or form part of an offering of
securities in any jurisdiction.
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(®) platforms, 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 Company Enquiries:
info@onwd.com (mailto:info@onwd.com)
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 Therapy(TM), and ARC-BCI(TM) 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 other than within
the Republic of France. 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 Private Placement Shares 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, provided that, in respect of
the Kingdom of Belgium only, Private Placement Shares may only be acquired for a
total consideration of at least EUR100,000 per investor. The Public Offered Shares
may and will only be offered in the Republic of France pursuant to Article
3(2) lit. b 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. Further for the purpose of this
paragraph, "Private Placement Shares" means the Securities that form part of the
Private Placement in the European Economic Area (other than France) and "Public
Offered Shares" means the Securities that form part of the Public Offer.
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, persons who are "qualified investors", within the meaning the U.K.
Prospectus Regulation, and who are also (i) investment professionals within the
meaning of Article 19(5) of the Financial Services and Markets Act 2000
(Financial Promotion) Order 2005, as amended (the "Order"), or (ii) high net
worth companies, unincorporated associations and other bodies to whom it may
otherwise lawfully be communicated in accordance with Article 49(2)(a) to (d) of
the 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) in connection with the issue or sale of any securities may
otherwise lawfully be communicated or caused to be communicated (all such
persons together 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
and Euronext Amsterdam. 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
Solely for the purposes of the product governance requirements contained within:
(a) EU Directive 2014/65/EU on markets in financial instruments, as amended from
time to time ("MiFID II"); (b) Articles 9 and 10 of Commission Delegated
Directive (EU) 2017/593 supplementing MiFID II; and (c) local implementing
measures (together, the "MiFID II Product Governance Requirements"), and
disclaiming all and any liability, whether arising in tort, contract or
otherwise, which any 'manufacturer' (for the purposes of the MiFID II Product
Governance Requirements) may otherwise have with respect thereto, the offered
shares have been subject to a product approval process, which has determined
that the offered shares are: (i) compatible with an end target market of retail
investors and investors who meet the criteria of professional clients and
eligible counterparties, each as defined in MiFID II; and (ii) eligible for
distribution through all distribution channels as are permitted by MiFID II (the
"Target Market Assessment"). 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.
Bryan, Garnier & Co, Degroof Petercam and KBC 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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