TIDMIRSH TIDMMSTY
Regulatory News:
On 7 April 2020, Mainstay Medical International plc (the
"Company" or "Mainstay") announced that it intended to establish a
new Irish holding company for the Mainstay group (the "Mainstay
Group"), Mainstay Medical Holdings plc ("Mainstay Holdings") and to
delist Mainstay's ordinary shares from Euronext Paris and the
Euronext Growth market operated by Euronext Dublin (the
"Delisting"). It is intended that this new corporate structure will
be a corporate reorganization implemented by means of a scheme of
arrangement under Chapter 1 of Part 9 of the Companies Act 2014
(the "Scheme").
Mainstay today applied to the High Court of Ireland (the
"Court") to set a date for the Court hearing, at which the Court
will be asked to approve the terms of the Scheme. The hearing will
take place in the High Court, sitting at the Four Courts, Inns
Quay, Dublin 7, Ireland at 11.00 a.m. on 4 June 2020. Further
information in relation to the hearing, including with respect to
the steps to be taken by any person intending to appear at the
hearing, will be available on the Company's website at
http://www.mainstay-medical.com/en/investors/governance.
About Mainstay
Mainstay is a medical device company focused on commercializing
an innovative implantable restorative neurostimulation system,
ReActiv8(R), for people with disabling Chronic Low Back Pain
(CLBP). The Company is headquartered in Dublin, Ireland. It has
subsidiaries operating in Ireland, the United States, Australia,
Germany and the Netherlands, and is listed on the regulated market
of Euronext Paris (MSTY.PA) and Euronext Growth operated by
Euronext Dublin (MSTY.IE).
About Chronic Low Back Pain
One of the root causes of CLBP is impaired control by the
nervous system of the muscles that dynamically stabilize the spine.
ReActiv8 is designed to electrically stimulate the nerves
responsible for contracting these muscles to improve dynamic spine
stability, allowing the body to recover from CLBP.
People with CLBP usually have a greatly reduced quality of life
and score significantly higher on scales for pain, disability,
depression, anxiety and sleep disorders. Their pain and disability
can persist despite the best available medical treatments, and only
a small percentage of cases result from an identified pathological
condition or anatomical defect that may be correctable with spine
surgery. Their ability to work or be productive is seriously
affected by the condition and the resulting days lost from work,
disability benefits and health resource utilization put a
significant burden on individuals, families, communities, industry
and governments.
Further information can be found at
www.mainstay-medical.com.
CAUTION -- in the United States, ReActiv8 is limited by federal
law to investigational use only.
Forward looking statements
This announcement includes statements that are, or may be deemed
to be, forward looking statements. These forward looking statements
can be identified by the use of forward looking terminology,
including the terms "anticipates," "believes," "estimates,"
"expects," "intends," "may, " "plans," "projects," "should,"
"will," or "explore" or, in each case, their negative or other
variations or comparable terminology, or by discussions of
strategy, plans, objectives, goals, future events or intentions.
These forward looking statements include all matters that are not
historical facts. They appear throughout this announcement and
include, but are not limited to, statements regarding the Company's
intentions, beliefs or current expectations concerning, among other
things, the establishment of a new holding company of the Mainstay
Group and the delisting of the Company's ordinary shares from
Euronext Paris and the Euronext Growth market of Euronext
Dublin.
By their nature, forward looking statements involve risk and
uncertainty because they relate to future events and circumstances.
Forward looking statements are not guarantees of future
performance, and the actual results of the Company's operations,
the development of its main product, and the markets and the
industry in which the Company operates may differ materially from
those described in, or suggested by, the forward looking statements
contained in this announcement. In addition, even if the Company's
results of operations, financial position and growth, and the
development of its main product and the markets and the industry in
which the Company operates are consistent with the forward looking
statements contained in this announcement, those results or
developments may not be indicative of results or developments in
subsequent periods. A number of factors could cause results and
developments of the Company to differ materially from those
expressed or implied by the forward looking statements, including,
without limitation, shareholder approval of the scheme of
arrangement, the outcome of the Company's interactions with the FDA
on a PMA application for ReActiv8 and the successful launch and
commercialization of ReActiv8. As a result, investors should not
rely on such forward-looking statements in making their investment
decisions. No representation or warranty is made as to the
achievement or reasonableness of, and no reliance should be placed
on, such forward-looking statements. The forward-looking statements
herein speak only at the date of this announcement. None of
Mainstay, the Mainstay Board, Mainstay Holdings or the Mainstay
Holdings Board assume any obligation to update or correct the
information contained in this announcement, whether as a result of
new information, future events or otherwise, except to the extent
legally required. Nothing contained in this announcement shall be
deemed to be a forecast, projection or estimate of the future
financial performance of the Mainstay Group except where expressly
stated.
Important Notices
The information contained in this announcement is for background
purposes only and does not purport to be full or complete. No
reliance may be placed for any purpose on the information contained
in this announcement or its accuracy, fairness or completeness.
The contents of this announcement are not to be construed as
legal, financial or tax advice. Each prospective investor should
consult his own legal adviser, financial adviser or tax adviser for
legal, financial or tax advice, respectively.
Disclaimers
This announcement and the information it contains does not
constitute and shall not be considered as constituting a public
offer, an offer to subscribe or an intention to solicit the
interest of the public for a public offering of Mainstay's
securities in Ireland, France, the United Kingdom, the United
States or any other jurisdiction. This announcement does not
comprise a prospectus or a prospectus equivalent document.
With respect to Member States of the European Economic Area, no
action has been taken or will be taken to permit a public offering
of the securities referred to in this announcement which would
require the publication of a prospectus in any Member State. There
will be no offer to the public of Mainstay Holdings Shares in any
Member State of the European Economic Area and no prospectus or
other offering document has been or will be prepared in connection
with the issue of Mainstay Holdings Shares.
J&E Davy, trading as Davy, which is authorised and regulated
in Ireland by the Central Bank of Ireland, is acting exclusively
for the Company and Mainstay Holdings and no one else in connection
with the Reorganization and will not be responsible to anyone other
than the Company and Mainstay Holdings for providing the
protections afforded to its clients or for providing any advice in
relation to the Reorganization or any matter referred to
herein.
The release, publication or distribution of this announcement
and the documents referred to herein in jurisdictions other than
Ireland, France and the United Kingdom may be restricted by law and
therefore persons into whose possession any of this announcement
and the documents referred to herein come should inform themselves
about, and observe, any applicable restrictions or requirements.
Any failure to comply with such restrictions may constitute a
violation of the securities laws of any such jurisdiction. To the
fullest extent permitted by applicable law, Mainstay and Mainstay
Holdings disclaim any responsibility or liability for the violation
of such requirements by any person.
Notice to investors in the United States
The Reorganization relates to the shares of an Irish company (a
"foreign private issuer" as defined under Rule 3b-4 under the U.S.
Securities Exchange Act of 1934 (the "Exchange Act")) and is
proposed to be made by means of a scheme of arrangement provided
for under, and governed by, Irish law (the "Scheme"). Neither the
proxy solicitation rules nor the tender offer rules under the
Exchange Act will apply to the Scheme. Accordingly, the Mainstay
Holdings Shares to be issued pursuant to the Scheme have not been
and will not be registered under the U.S. Securities Act of 1933
(the "Securities Act") or under the relevant securities laws of any
State or territory or other jurisdiction of the United States, and
are expected to be offered in the United States in reliance upon
the exemption from the registration requirements of the Securities
Act provided by section 3(a)(10) thereof and exemptions provided
under the laws of the States of the United States in which eligible
Scheme Shareholders may reside.
For the purpose of qualifying for the exemption from the
registration requirements of the Securities Act provided by section
3(a)(10) thereof with respect to the Mainstay Holdings Shares
issued pursuant to the Scheme, Mainstay will advise the Court that
its sanctioning of the Scheme will be relied upon by Mainstay
Holdings as an approval of the Scheme, following a hearing on its
fairness to Scheme Shareholders at which hearing all Scheme
Shareholders are entitled to attend in person or through counsel to
support or oppose the sanctioning of the Scheme and with respect to
which notification has been given to all such Scheme
Shareholders.
The Mainstay Holdings Shares to be issued under or in connection
with the Scheme to a Scheme Shareholder who is neither an
affiliate, for the purpose of the Securities Act, of Mainstay or
Mainstay Holdings on or prior to the time the Scheme becomes
effective nor an affiliate of Mainstay Holdings at the time the
Scheme becomes effective (the "Scheme Effective Time") would not be
"restricted securities" under the Securities Act. Scheme
Shareholders who are affiliates of Mainstay or Mainstay Holdings on
or prior to the Scheme Effective Time or affiliates of Mainstay
Holdings after the Scheme Effective Time may, under Rule 145(d)
under the Securities Act, be subject to timing, manner of sale and
volume restrictions on the sale of Mainstay Holdings Shares
received in connection with the Scheme. For the purpose of the
Securities Act, an affiliate of either Mainstay or Mainstay
Holdings is any person who directly or indirectly through one or
more intermediaries controls, or is controlled by, or is under
common control with Mainstay or Mainstay Holdings respectively.
Whether a person is an affiliate of either Mainstay or Mainstay
Holdings for the purpose of the Securities Act depends on the
circumstances. Persons who believe that they may be affiliates of
either Mainstay or, after the Scheme Effective Time, Mainstay
Holdings should consult their own legal advisers prior to any sale
of the Mainstay Holdings Shares received upon the implementation of
the Scheme.
The Scheme is subject to the disclosure requirements and
practices applicable in Ireland to schemes of arrangement, which
differ from the disclosure and other requirements of U.S.
securities laws.
Mainstay and Mainstay Holdings are both incorporated under the
laws of Ireland. Some or all of the officers and directors of
Mainstay and Mainstay Holdings may be residents of countries other
than the United States. It may not be possible to sue Mainstay and
Mainstay Holdings in a non-U.S. court for violations of U.S.
securities laws. It may be difficult to compel Mainstay, Mainstay
Holdings and their respective affiliates to subject themselves to
the jurisdiction and judgment of a U.S. court. It may not be
possible to enforce in Ireland a judgment of a U.S. court in
respect of violations of U.S. securities law.
None of the securities referred to in this announcement have
been approved or disapproved by the U.S. Securities and Exchange
Commission, any state securities commission in the United States or
any other U.S. regulatory authority, nor have such authorities
passed upon or determined the adequacy or accuracy of the
information contained in this announcement. Any representation to
the contrary is a criminal offence in the United States.
There will be no public offer of securities in the United
States.
View source version on businesswire.com:
https://www.businesswire.com/news/home/20200525005243/en/
CONTACT: PR and IR Enquiries:
LifeSci Advisors, LLC
Brian Ritchie
Tel: + 1 (212) 915-2578
Email: britchie@lifesciadvisors.com
FTI Consulting (for Ireland)
Jonathan Neilan or Patrick Berkery
Tel. : +353 1 765 0886
Email: mainstay@fticonsulting.com
Euronext Advisers:
Davy
Fergal Meegan or Barry Murphy
Tel: +353 1 679 6363
Email: fergal.meegan@davy.ie or barry.murphy2@davy.ie
SOURCE: Mainstay Medical International plc
Copyright Business Wire 2020
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