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 announced that on
10 December 2019 the Company completed a Day 100 meeting with the
U.S. Food and Drug Administration (FDA) regarding a Pre-Market
Approval (PMA) application submission for ReActiv8.
Jason Hannon, CEO of Mainstay, said:"We appreciate the
opportunity to meet with FDA to discuss their review of the data we
included in the PMA. The productive dialogue will help us submit an
amendment to the PMA to reflect FDA's feedback. We continue to
expect a decision regarding approval around the end of 2020."
FDA generally meets with the PMA sponsor approximately 100 days
after filing of the PMA for the purpose of discussing the status of
the review of the application. Prior to the meeting, FDA provided
Mainstay with its initial feedback on the PMA, consisting of
questions regarding the data included in the PMA and the
interpretation of such data. The Company currently has no plans to
conduct another premarket pivotal IDE trial for ReActiv8.
Mainstay will include the information requested by FDA in an
amendment to the PMA, which the Company expects to file in the
first quarter 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 the regulated market
of Euronext Paris (MSTY.PA) and Euronext Growth operated by
Euronext Dublin (MSTY.IE).
About the ReActiv8-B Study
The ReActiv8-B Study is an international, multi-center,
prospective, randomized, sham-controlled, blinded trial with
one-way crossover conducted under an Investigational Device
Exemption (IDE). In summary, this means that eligible patients had
baseline data collected and then following verification that the
enrollment criteria were met, ReActiv8 was implanted. At the 14-day
post implant follow up visit, half the patients were randomized to
receive appropriately programmed stimulation (the treatment arm),
and half were randomized to receive sham stimulation/low
stimulation (the control arm). Information about the study can be
found at https://clinicaltrials.gov/ct2/show/study/NCT02577354.
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 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 plans to file an amendment to its PMA application with
the FDA for ReActiv8, the timing of such filing and of the FDA's
review of such amended 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 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/20191211005614/en/
This information is provided by Business Wire
(END) Dow Jones Newswires
December 11, 2019 12:00 ET (17:00 GMT)
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