TIDMIRSH
Mainstay Medical International plc ("Mainstay" or the "Company",
Euronext Paris: MSTY.PA and Euronext Growth of Euronext Dublin:
MSTY.IE), a medical device company focused on bringing to market
ReActiv8®, an implantable neurostimulation system to treat
disabling Chronic Low Back Pain, today announces that the U.S. Food
and Drug Administration (FDA) has accepted for filing the Company's
Pre-Market Approval (PMA) application for ReActiv8.
Mainstay submitted the PMA to the FDA in August. Per regulation,
the FDA will notify the applicant whether the PMA has been accepted
for filing within 45 days after submission. By accepting the
Company's PMA for filing, the FDA has made a threshold
determination that the application is sufficiently complete to
begin an in-depth review. Mainstay continues to expect a decision
on approval around the end of 2020.
- 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 regulated market of
the Euronext Paris (MSTY.PA) and the Euronext Growth market 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.
PR and IR Enquiries:LifeSci Advisors, LLCBrian 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 Growth 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
FDA's review of the Company's PMA application for ReActiv8, the
clinical data relating to ReActiv8, and the potential for the FDA
to approve ReActiv8 for marketing in the United States.
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 trial, the outcome of the Company's interactions with the
FDA on the 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.
View source version on businesswire.com:
https://www.businesswire.com/news/home/20190930005658/en/
This information is provided by Business Wire
(END) Dow Jones Newswires
October 01, 2019 02:00 ET (06:00 GMT)
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