TIDMIRSH
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 headline
results from its ReActiv8-B study.
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. In the treatment
group, the ReActiv8 pulse generator was programmed to deliver
electrical stimulation expected to elicit contractions of the
multifidus muscle. In the control group, the ReActiv8 device was
programmed to provide a low level of electrical stimulation.
Following assessment of the primary endpoint at 120 days, patients
in the control group crossed-over to receive levels of electrical
stimulation as in the treatment group.
The patients in the study had an average age of 46, and an
average duration of chronic low back pain of 14 years. This patient
population has tried many other treatment alternatives with limited
success, and 80% of the patients were on pain medication at
baseline.
Efficacy Outcomes
The primary efficacy endpoint of the study was a comparison of
responder rates between the treatment and control groups as
measured on the visual analog scale (VAS) of pain, with responders
defined as having a 30% or greater improvement on this measure
between baseline and 120 days after randomization, without any
increase in pain medication taken in the two weeks prior to the
primary endpoint assessment visit. In the treatment group the
responder rate at 120 days was 56%, compared to 47% in the control
group, resulting in a difference that is not statistically
significant.
ReActiv8-B is the first ever active sham-controlled clinical
trial of an implantable neurostimulator for chronic low back pain.
The literature from other sham or placebo-controlled studies,
involving drugs, device implants or other interventions, suggested
that a responder rate of 20% or more could have been expected in
the control group. The study design assumed a 25% responder rate in
the control group.
"Our study involved surgically implanting a device into patients
who had not previously received surgical implants, and further
required the patient to activate the device twice daily to
administer the therapy," said Jason Hannon, Chief Executive Officer
of Mainstay. "The study design underestimated the amount and
duration of the sham effect under these conditions.
"The overall results of this study, however, are a solid
endorsement of the efficacy and safety of ReActiv8," continued Mr.
Hannon. "We saw very high responder rates in the patients in the
treatment group that have reached one year of therapy, and
substantial improvement in the patients that were crossed-over to
treatment from the control group after 120 days. We believe these
long-term results represent the most important clinical factors to
physicians, and we plan to leverage these results in continuing to
drive our commercial business under our existing CE Mark in
Europe."
Responder Rates Grow to 1 Year
Improvements in the percentage of patients reporting pain
reduction continued beyond the 120-day assessment through one year
for both groups. The percentage of the 56 patients in the treatment
group that have completed the one-year assessment having a 30% or
greater reduction in low back pain VAS at that assessment without
an increase in pain medication was 75%. The percentage of the 60
patients in the cross-over group that have completed the one-year
assessment having a 30% or greater reduction in low back pain VAS
at that assessment without an increase in pain medication was 68%.
The percentage of the 116 patients in the both groups that have
completed the one-year assessment having a 50% or greater reduction
in low back pain VAS at one year without an increase in pain
medication was 60%. Substantial improvements in disability as
measured by the Oswestry Disability Index (ODI) were also observed
at one year. These data are subject to change as the remaining
patients reach the one-year assessment.
"The totality of this data is encouraging for this large group
of patients with limited treatment alternatives," said Dr. Chris
Gilligan, Chief, Division of Pain Medicine, Department of
Anesthesiology, Perioperative and Pain Medicine, Brigham &
Women's Hospital, Assistant Professor of Anaesthesia, Harvard
Medical School, and Principal Investigator for the study. "The data
on the patients that have completed one year of therapy are
important, particularly because these patients have not experienced
meaningful pain relief from existing treatment options. The data
showing 60% of patients experiencing a 50% or greater pain
reduction at one year surpasses what many implanting physicians
expect from implantable neurostimulation devices."
Results Demonstrate Voluntary Decrease in Back Pain Medication
Use
The protocol permitted patients to adjust their back pain
medication usage after the 120-day assessment point. At one year,
44% of the 50 patients who were on opioids at baseline had
voluntarily eliminated (28%) or significantly reduced (16%) their
use of opioids. These results are subject to change as the
remaining patients reach the one-year assessment.
Secondary Endpoints
For secondary endpoints, such as disability measured by the ODI
and quality of life measured by the EQ-5D quality of life
instrument, numerical improvements in the treatment group as
compared to the control group were observed at 120 days. The
Company is evaluating the clinical significance of those findings.
The Company continues to analyze the efficacy data for the purpose
of better understanding the performance of the device.
Device-Related Adverse Events in Line With Other Studies
ReActiv8 is implanted in a minimally invasive procedure
utilizing techniques commonly used by our physician customer base
in other procedures. The incidence and type of adverse events
(AEs), including serious AEs, were comparable to AEs in clinical
trials reported for other neurostimulation devices, with no
unanticipated AEs related to the device, procedure or
stimulation.
"The study showed a comparable safety profile to other
implantable neurostimulation devices, including no migration of
leads," said Dr. Richard Rauck, President and Founder, Carolinas
Pain Institute, Medical Director for The Center for Clinical
Research, Pain Fellowship Director at Wake Forest University School
of Medicine and Chairman of the DMC. "This safety profile, combined
with the efficacy data from this study and the lack of available
alternatives for this patient population, suggest that ReActiv8 can
be a promising therapy for patients with chronic low back
pain."
PMA Plan
"In summary, we believe the evidence of effectiveness and the
favorable safety profile of ReActiv8 show considerable promise,
particularly when compared to the response rates and safety
profiles of alternative treatments," continued Mr. Hannon. "We
believe that the totality of the data will support the submission
of a PMA application for ReActiv8 to the FDA. We plan to seek a
pre-PMA meeting with the FDA in the coming months to obtain
guidance on our filing content and strategy."
Investor Conference Call
Jason Hannon, Chief Executive Officer, will host a conference
call and webcast with Q&A for analysts and investors to discuss
the results from the study at 8:00am GMT (9:00am CET) on 19
November 2018. The call will be conducted in English. The webcast
will be made available on Mainstay's website at
www.mainstay-medical.com on the News & Events tab. The
presentation and webcast will be available on the Mainstay Medical
website one hour before the call, and a replay will be available
for 30 days.
Webcast link: https://edge.media-server.com/m6/p/gy64sk9n
Dial-in details for the call are:UK: +44 333 300 0804Ireland:
+353 1 431 1252France: +33 170 750 711Germany: +49 691 380 3430USA:
+1 631 913 1422Participant PIN: 18286266#
This announcement contains inside information within the meaning
of the EU Market Abuse Regulation 596/2014.
About MainstayMainstay 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 StudyThe 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 PainOne 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.
Forward looking statementsThis 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 discussions 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.
PR and IR Enquiries:
Consilium Strategic Communications (international strategic
communications - business and trade media)Chris Gardner, Jessica
Hodgson, Nicholas BrownTel: +44 203 709 5700 / +44 7921 697
654Email: mainstaymedical@consilium-comms.com
FTI Consulting (for Ireland):Jonathan NeilanTel: +353 1 765
0886Email: jonathan.neilan@fticonsulting.com
NewCap (for France)Julie CoulotTel: +33 1 44 71 20 40Email:
jcoulot@newcap.fr
AndreasBohne.Com/Kötting Consulting (for Germany)Andreas
BohneTel : +49 2102 1485368Email : abo@andreasbohne.com
Wilhelm KöttingTel: +49 69 75913293Email: wkotting@gmail.com
Investor Relations:
LifeSci Advisors, LLCBrian RitchieTel: + 1 (212) 915-2578Email:
britchie@lifesciadvisors.com
ESM Advisers:DavyFergal Meegan or Barry MurphyTel: +353 1 679
6363Email: fergal.meegan@davy.ie or barry.murphy2@davy.ie
View source version on businesswire.com:
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(END) Dow Jones Newswires
November 19, 2018 02:00 ET (07:00 GMT)
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