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 completion of all implants in
ReActiv8-B, its US IDE clinical study.
A total of 204 patients were implanted in the study, reflecting
the strength of interest in study participation. The implants were
completed in accordance with the Company's planned timeline and the
Company expects to announce a full data readout towards the end of
2018.
Jason Hannon, CEO of Mainstay, said: "Completingall
implantsinthe ReActiv8-B study is a significant step for Mainstay
and represents continued momentum in our efforts to bring ReActiv8
to patients in the US. We remain on track to have full study data
towards the end of 2018. I would like to thank the study
participants and investigators for their participation -- we look
forward to announcing the results of the study later this
year."
ReActiv8-B is an international, multi-centre, prospective,
randomized, sham-controlled triple-blinded study with one-way
crossover, conducted under an IDE from the US Food & Drug
Administration (FDA). The study is intended to gather data in
support of a pre-market approval (PMA) application to the FDA, a
key step towards the commercialization of ReActiv8 in the US. The
study utilizes an adaptive trial design, inclusive of an interim
analysis. In December 2017 the Company announced a positive outcome
of the interim analysis.
- 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.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 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.frorAndreasBohne.Com/Kötting Consulting (for
Germany)Andreas BohneTel : +49 2102 1485368Email :
abo@andreasbohne.comorWilhelm KöttingTel: +49 69 75913293Email:
wkotting@gmail.comorInvestor 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
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/20180708005016/en/
This information is provided by Business Wire
(END) Dow Jones Newswires
July 09, 2018 02:00 ET (06:00 GMT)
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