TIDMIRSH
Mainstay Medical International plc (Mainstay or the Company,
Euronext Paris: MSTY.PA and Euronext Dublin: MSTY.IE), a medical
device company focused on bringing to market ReActiv8®, an
implantable restorative neurostimulation system to treat disabling
Chronic Low Back Pain, announces the publication of a prospectus
(Prospectus) in connection with the admission of 2,151,332 new
ordinary shares (New Shares) to trading on the regulated market of
Euronext Paris. The New Shares will also be admitted to trading on
the ESM of Euronext Dublin. The New Shares were issued pursuant to
a EUR30.1 million equity fundraising announced on 15 February
2018.
Application has been made to Euronext Paris and to Euronext
Dublin for the New Shares to be admitted to listing and trading on
the regulated market of Euronext Paris and to trading on the ESM of
Euronext Dublin, respectively (Admission). It is expected that
Admission of the New Shares will become effective, and that
dealings in the New Shares will commence, at 8.00 a.m. Irish
Standard Time / 9.00 a.m. CET on 9 May 2018.
The Prospectus has been approved by the Central Bank of Ireland
and is publicly available on the Company's website at
www.mainstay-medical.com/investors. The Company has requested that
the Central Bank of Ireland provide a certificate of approval and a
copy of the Prospectus, together with a translation of the summary
of the Prospectus into the French language, to the French Autorité
des Marchés Financiers. A translation of the summary of the
Prospectus into the French language will be shortly available on
the websites of the Company and the French Autorité des Marchés
Financiers (www.amf-france.org).
- End -
About Mainstay
Mainstay is a medical device company focused on bringing to
market an innovative implantable restorative neurostimulation
system, ReActiv8®, 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 the ESM of Euronext Dublin
(MSTY.IE).
About Chronic Low Back Pain
One of the recognized root causes of CLBP is impaired control by
the nervous system of the muscles that dynamically stabilize the
spine in the low back, and an unstable spine can lead to back pain.
ReActiv8 is designed to electrically stimulate the nerves
responsible for contracting these muscles and thereby help to
restore muscle control and 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
Company's results of operations, financial position, prospects,
financing strategies, expectations for product design and
development, regulatory applications and approvals, reimbursement
arrangements, costs of sales and market penetration.
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, and the
development of its main product, 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, the successful launch and commercialization of
ReActiv8, the progress and success of the ReActiv8-B Clinical
Trial,general economic and business conditions, the global medical
device market conditions, industry trends, competition, changes in
law or regulation, changes in taxation regimes, the availability
and cost of capital, the time required to commence and complete
clinical trials, the time and process required to obtain regulatory
approvals, currency fluctuations, changes in its business strategy,
political and economic uncertainty. The forward-looking statements
herein speak only at the date of this announcement.
Disclaimers
This announcement is not an offer of securities for sale in any
jurisdiction. This announcement is not a prospectus (or prospectus
equivalent document) or an advertisement. Investors should not
subscribe for or purchase any shares in the Company based on this
announcement or the prospectus. Neither this announcement nor any
part of it shall form the basis of or be relied on in connection
with or act as an inducement to enter into any contract or
commitment whatsoever.
No reliance may be placed for any purpose on the information
contained in this announcement or its accuracy or completeness. The
material set forth herein is for information purposes only and
should not be construed as an offer of securities for sale in any
jurisdiction.
No action has been taken by the Company to permit a public offer
of New Ordinary Shares under the applicable securities laws of any
jurisdiction. Other than in Ireland and France, no action has been
taken or will be taken to permit the possession or distribution of
the Prospectus (or any other offering or publicity materials
relating to the New Ordinary Shares, including this announcement)
in any jurisdiction where action for that purpose may be required
or where doing so is restricted by law. Accordingly, neither this
announcement nor the Prospectus may be distributed or published in
any other jurisdiction except under circumstances that will result
in compliance with any applicable laws and regulations. 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.
Persons into whose possession this document comes should inform
themselves about and observe any such restrictions. Any failure to
comply with these restrictions may constitute a violation of the
securities laws of any such jurisdiction.
J&E Davy ("Davy") is acting as Financial Adviser to the
Company in connection with Admission. Davy, which is regulated in
Ireland by the Central Bank of Ireland, is acting for the Company
and for no one else in connection with Admission and will not be
responsible to any person other than the Company for providing the
protections afforded to clients of Davy, nor for providing advice
in relation to Admission, the content of this announcement or any
matter referred to in this announcement. Apart from the
responsibilities and liabilities, if any, which may be imposed on
Davy by the Central Bank of Ireland, or the regulatory regime in
Ireland, neither Davy nor any of its subsidiaries, branches or
affiliates owes or accepts any duty, liability or responsibility
whatsoever (whether direct or indirect, whether in contract, in
tort, under statute or otherwise) to any person who is not a client
of Davy in connection with this announcement, any statement
contained herein or otherwise, nor makes any representation or
warranty, express or implied, in relation to, the contents of this
announcement, including its accuracy, completeness or verification
or for any other statement purported to be made by Davy, or on
behalf of Davy in connection with the Company or Admission. Davy
accordingly disclaims to the fullest extent permitted by law all
and any responsibility or liability to any person who is not a
client of Davy, whether arising in tort, contract or otherwise
(save as referred to above) which they might otherwise have in
respect of this announcement or any such statement.
This announcement does not constitute or form part of any offer
or solicitation to purchase or subscribe for, nor does it
constitute an offer to sell, or the solicitation of an offer to buy
Ordinary Shares in the United States or in any jurisdiction in
which such offer, solicitation or sale would be unlawful prior to
its registration or qualification under the laws of such
jurisdiction. The New Shares mentioned herein have not been, and
will not be, registered under the U.S. Securities Act of 1933 (the
"Securities Act"). The New Shares may not be offered or sold in the
United States except pursuant to an effective registration
statement under, or an exemption from the registration requirements
of, the Securities Act. There will be no public offer of securities
in the United States.
Information to distributors
Solely for the purposes of the product governance requirements
contained within: (a) 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 New
Shares have been subject to a product approval process, which has
determined that such New 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 New Shares may
decline and investors could lose all or part of their investment;
the New Shares offer no guaranteed income and no capital
protection; and an investment in the New 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 offer of the New Shares. 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 New Shares. Each distributor is responsible for undertaking
its own target market assessment in respect of the New Shares and
determining appropriate distribution channels.
This distribution of this announcement may be subject to legal
or regulatory restrictions in certain jurisdictions. Any person who
comes into possession of this announcement must inform him or
herself of and comply with any such restrictions.
PR and IR Enquiries:Consilium Strategic Communications
(international strategic communications - business and trade
media)Chris Gardner, Jessica Hodgson, Nicholas BrownTel: +44 203
709 5700 / +44 7921 697 654Email:
mainstaymedical@consilium-comms.comorFTI Consulting (for
Ireland):Jonathan NeilanTel: +353 1 765 0886Email:
jonathan.neilan@fticonsulting.comorNewCap (for France)Julie
CoulotTel: +33 1 44 71 20 40Email: jcoulot@newcap.frorInvestor
Relations:LifeSci Advisors, LLCBrian RitchieTel: + 1 (212)
915-2578Email: britchie@lifesciadvisors.comorESM
Advisers:DavyFergal Meegan or Barry MurphyTel: +353 1 679
6363Email: fergal.meegan@davy.ie or barry.murphy2@davy.ie
View source version on businesswire.com:
https://www.businesswire.com/news/home/20180504005549/en/
This information is provided by Business Wire
(END) Dow Jones Newswires
May 04, 2018 10:58 ET (14:58 GMT)
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