TIDMIRSH
Mainstay Medical International plc (Mainstay or the Company,
Euronext Paris: MSTY.PA and ESM of the Irish Stock Exchange:
MSTY.IE), a medical device company focused on bringing to market
ReActiv8®, an implantable restorative neurostimulation system to
treat disabling Chronic Low Back Pain, today provides an update on
its application for the admission of ReActiv8 to the Australian
Register of Therapeutic Goods (ARTG), which the Company filed in
January 2017.
The Therapeutic Goods Administration (TGA) has requested
additional clinical data with respect to ReActiv8. To provide the
most meaningful clinical data possible, we intend to rely on the
clinical data being gathered as part of the ongoing ReActiv8-B
clinical study. As stated previously, this clinical study is
expected to be fully enrolled by the end of the second quarter of
2018, with a full data readout expected towards the end of 2018.
Upon availability of the ReActiv8-B data, we plan to submit a new
application to the TGA seeking admission of ReActiv8.
The Therapeutic Goods Administration may request additional
information during the review process. Review of an application for
admission of a product to the ARTG has varied historically. The TGA
is required to complete assessment of applications within
approximately one year.
- 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 and
Germany, and its ordinary shares are admitted to trading on
Euronext Paris (MSTY.PA) and the ESM of the Irish Stock Exchange
(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.mainstaymedical.com
CAUTION - in the United States, ReActiv8 is limited by federal
law to investigational use only.
PR and IR Enquiries:Consilium Strategic Communications
(international strategic communications - business and trade
media)Chris Gardner, Jessica Hodgson, Nicholas Brown, +44 203 709
5700 / +44 7921 697 654mainstaymedical@consilium-comms.comorFTI
Consulting (for Ireland):Jonathan Neilan, +353 1 765
0886jonathan.neilan@fticonsulting.comorNewCap (for France)Julie
Coulot, +33 1 44 71 20 40jcoulot@newcap.frorInvestor
Relations:LifeSci Advisors, LLCBrian Ritchie, + 1 (212)
915-2578britchie@lifesciadvisors.comorESM Advisers:DavyFergal
Meegan or Barry Murphy +353 1 679 6363fergal.meegan@davy.ie or
barry.murphy2@davy.ie
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.
View source version on businesswire.com:
https://www.businesswire.com/news/home/20180404006308/en/
This information is provided by Business Wire
(END) Dow Jones Newswires
April 05, 2018 02:00 ET (06:00 GMT)
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