TIDMIRSH
Mainstay Medical to Showcase ReActiv8 and Key Clinical Data at
the 13th German Spine Congress of the DWG
Mainstay Medical International plc ("Mainstay" or the "Company",
Euronext Paris: MSTY.PA and Euronext Dublin: MSTY.IE), a medical
device company focused on commercializing ReActiv8®, an implantable
restorative neurostimulation system designed to treat an underlying
cause of disabling Chronic Low Back Pain, today announces that it
will participate in the 13th German Spine Congress of the Deutsche
Wirbelsäulengesellschaft (DWG), taking place in Wiesbaden from
December 6-8. DWG will be the first medical meeting at which
pivotal clinical data from the Company's ReActiv8-B clinical study
will be discussed.
A distinguished faculty of physicians, each of whom has deep
experience with Reactiv8, will present the clinical data and the
scientific background of the therapy, and describe commercial
treatment of patients in Germany:
-- Dr. Jörg Franke, Chief, Department of Orthopedics, Klinikum Magdeburg,
will chair the symposium where the results from the ReActiv8-B
study
will be presented, and also provide his experience with ReActiv8
in
Germany;
-- Dr. Chris Gilligan, Chief, Division of Pain Medicine, Department of
Anaesthesiology, Perioperative and Pain Medicine Brigham &
Women's
Hospital, Assistant Professor of Anaesthesia, Harvard Medical
and
Principal investigator of the study, will present the pivotal
clinical
data from the ReActiv8-B study;
-- Dr. Jan Schilling, Chief of Spine and Neurosurgery, Tabea Hospital in
Hamburg, will introduce the scientific background and the
underlying
physiological mechanisms of this new restorative treatment for
chronic
low back pain; and
-- Dr. Ardeshir Ardeshiri, Chief of Spine Surgery at Klinikum Itzehoe,
will present his "real world" experience with ReActiv8 in
Germany via
his initial series of patient outcomes.
"As Germany is our first commercial market for ReActiv8, I am
excited to be unveiling the data from our ReActiv8-B clinical study
to the scientific community at the German Spine Congress," said
Jason Hannon, Chief Executive Officer of Mainstay. "We believe the
long-term clinical results demonstrated in the study are
compelling, particularly that we are seeing more than 60% of the
study patients reporting greater than 50% pain relief at one year.
We look forward to discussing the results with the attending
physicians, and we plan to leverage the study results in continuing
to drive our commercial business in Germany and more broadly in
Europe."
"The data from the ReActiv8-B clinical study through one year,
and the favourable safety profile demonstrate that ReActiv8 is a
viable restorative treatment option for patients with chronic low
back pain," said Dr. Franke. "ReActiv8 has the potential to provide
long-term pain relief to this patient population, which suffers
from a lack of available treatment alternatives."
The ReActiv8 B clinical study is an international, multi-center,
prospective, randomized, active-controlled, blinded trial with
one-way cross-over, conducted under an Investigational Device
Exemption (IDE) from the U.S. Food & Drug Administration (FDA).
A total of 204 patients were implanted with ReActiv8 at leading
study centers in the U.S., Europe and Australia and randomized 1:1
to therapy or control 14 days after implant. The initial results
from this clinical study were announced by Mainstay on November 19,
2018.
"The results from this study confirm the results we have seen in
our own experience with chronic mechanical low back pain patients
with ReActiv8," said Dr. Schilling. "There is an urgent need for
new, effective therapies to treat long-term, mechanical low back
pain, and the data from the studies demonstrate that ReActiv8 can
provide sustained pain reduction over time."
Mainstay will hold a ReActiv8-B symposium at which the physician
faculty will make their presentations. The symposium will take
place on Friday, December 7 from 13:00 - 14:30 in Studio 1.2 A
& B at the Rhein Main Congress Center. Seating is limited.
Pre-registration is available through www.reactiv8-B.de.
The Company will also have a booth at the DWG Congress, location
number 26, and Mainstay leadership and the symposium faculty will
be available for further discussions throughout the conference.
- 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 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 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.mainstay-medical.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 Brown
Tel: +44 203 709 5700 / +44 7921 697 654
Email: mainstaymedical@consilium-comms.com
FTI Consulting (for Ireland):
Jonathan Neilan
Tel: +353 1 765 0886
Email: jonathan.neilan@fticonsulting.com
NewCap (for France)
Julie Coulot
Tel: +33 1 44 71 20 40
Email: jcoulot@newcap.fr
AndreasBohne.Com/Kötting Consulting (for Germany)
Andreas Bohne
Tel : +49 2102 1485368
Email : abo@andreasbohne.com
Wilhelm Kötting
Tel: +49 69 75913293
Email: wkotting@gmail.com
Investor Relations:
LifeSci Advisors, LLC
Brian Ritchie
Tel: + 1 (212) 915-2578
Email: britchie@lifesciadvisors.com
ESM Advisers:
Davy
Fergal Meegan or Barry Murphy
Tel: +353 1 679 6363
Email: 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
data from the ReActiv8-B clinical study, the Company's plans in
relation to that data, 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,
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 outcome of the ReActiv8-B Clinical Study,the outcome
of the Company's interactions with the FDA on a PMA application for
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/20181203005531/en/
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(END) Dow Jones Newswires
December 03, 2018 11:30 ET (16:30 GMT)
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