TIDMIRSH
Mainstay Medical International plc ("Mainstay" or the "Company",
Euronext Paris: MSTY.PA and Euronext Growth operated by 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, today announces that on
25 June 2019 the Company completed a pre-submission meeting with
the U.S. Food and Drug Administration regarding a Pre-Market
Approval (PMA) application submission for ReActiv8.
Jason Hannon, CEO of Mainstay, said: "We believe in a rigorous,
evidence-based approach to the evaluation of ReActiv8, and we
appreciate the opportunity to meet with the FDA on the data we have
generated to date relating to the efficacy and safety of this novel
therapy. We expect to submit the final module of our PMA
application to the FDA relating to ReActiv8 this summer, with a
decision on approval expected around the end of 2020."
Separately, Mainstay also announced that it has entered into an
amendment to its agreement with IPF Partners relating to its
existing debt facility. Under the amendment, the deadline for
Mainstay to qualify to draw down a new tranche of EUR3.0 million
(approximately $3.34 million) in debt was extended from June 30,
2019 to July 31, 2019.
- End -
About Mainstay
Mainstay is a medical device company focused on commercializing
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 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
Company's plans to file a PMA application with the FDA for
ReActiv8, the timing of such filing and of the FDA's review of such
application, the clinical data relating to ReActiv8, the potential
for the FDA to approve ReActiv8 for marketing in the United States,
and 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
and other commercial performance.
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, the final outcome of the Company's ReActiv8-B
clinical study, the outcome of the Company's interactions with the
FDA on a PMA application for ReActiv8, the successful launch and
commercialization of ReActiv8, general economic and business
conditions, 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, and political and
economic uncertainty. The forward-looking statements herein speak
only at the date of this announcement.
PR and IR Enquiries: LifeSci Advisors, LLC Brian RitchieTel: + 1
(212) 915-2578Email: britchie@lifesciadvisors.com
FTI Consulting (for Ireland) Jonathan Neilan or Patrick
BerkeryTel. : +353 1 765 0886Email: mainstay@fticonsulting.com
Euronext Advisers: Davy Fergal 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/20190626005325/en/
This information is provided by Business Wire
(END) Dow Jones Newswires
June 26, 2019 05:25 ET (09:25 GMT)
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