TIDMIRSH
Mainstay Medical International plc ("Mainstay" or the "Company",
Euronext Paris: MSTY.PA and Euronext Growth operated by Euronext
Dublin (MSTY.IE), today announced that it has received regulatory
approval from the Australian Therapeutic Goods Administration (TGA)
for ReActiv8, its implantable restorative neurostimulation system
to treat disabling Chronic Low Back Pain. This approval confirms
inclusion of ReActiv8 in the Australian Register of Therapeutic
Goods (ARTG), enabling commercialization throughout Australia.
Jason Hannon, CEO of Mainstay, said: "We are excited to receive
TGA approval and take the next step toward making ReActiv8
available to patients in Australia. Australian physicians who have
been part of our clinical studies to date are among the most
experienced globally in selecting and treating patients with
ReActiv8 therapy. The clinical data in support of ReActiv8
continues to build and was instrumental in demonstrating to TGA
that ReActiv8 is a valuable therapy that should be available to
Australian patients. We are moving to the next step in the process,
which is applying for inclusion of ReActiv8 on the Prostheses List.
We plan to launch ReActiv8 commercially after securing a place on
the Prostheses List."
The Company plans to submit an application for ReActiv8 to be
included in the Prostheses List of reimbursed products, with a
reimbursement decision expected in the third quarter of 2020. The
Prostheses List identifies implantable devices eligible for
reimbursement from all private health insurance funds in
Australia.
About ReActiv8
ReActiv8 is an active implantable medical device designed to
treat people with chronic low back pain (CLBP). ReActiv8
electrically stimulates the nerves that supply the lumbar
multifidus muscle, a key stabilizing muscle of the low back, to
elicit contraction of the muscle which can lead to restoration of
control over time, allowing the back to recover from CLBP.
Low back pain is the number one cause of years lived with
disability worldwide and is a leading cause of activity limitation
and work absence throughout much of the world, imposing a high
economic burden on individuals, families, communities, industry,
and governments. While treatment options exist for patients with
CLBP of a predominantly neuropathic origin, for the large portion
of patients whose pain is predmoniantly nociceptive (or mechanical)
in nature there are few therapies beyond drugs and injections, both
of which offer temporary relief at best. ReActiv8 is intended for
those patients without indications for spine surgery or spinal cord
stimulation and who have continuing pain despite medical
management.
The Company estimates that there are approximately two million
people in the EU and the U.S. alone who could be candidates for
ReActiv8 today.
ReActiv8 has a CE Mark allowing for commercialization in the
European Economic Area and has been focused on building clinical
validation in Germany in select centers ahead of wider commercial
availability in the future. The Company submitted the final module
of its Pre-Market Approval (PMA) application to the U.S. FDA
relating to ReActiv8 in August 2019, and it expects an approval
decision around the end of 2020.
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.
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 application for inclusion on the
Australian Prostheses List, the timing of such filing and of the
review of such application; the Company's plans to commercialize
ReActiv8; the commercial performance of ReActiv8 in the EU,
Australia or elsewhere; 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 Ritchie+ 1
(212) 915-2578britchie@lifesciadvisors.com
FTI Consulting (for Ireland) Jonathan Neilan or Patrick
Berkery+353 1 765 0886mainstay@fticonsulting.com
Euronext Advisers: Davy Fergal Meegan or Barry Murphy+353 1 679
6363fergal.meegan@davy.ie or barry.murphy2@davy.ie
View source version on businesswire.com:
https://www.businesswire.com/news/home/20191205005964/en/
This information is provided by Business Wire
(END) Dow Jones Newswires
December 06, 2019 02:00 ET (07:00 GMT)
Mainstay Medical (LSE:0QUD)
Historical Stock Chart
From May 2024 to Jun 2024
Mainstay Medical (LSE:0QUD)
Historical Stock Chart
From Jun 2023 to Jun 2024