Mainstay Medical Starts Commercialization of ReActiv8® for the Treatment of Chronic Low Back Pain in Ireland

DUBLIN--()--Regulatory News:

Mainstay Medical International plc (“Mainstay” or the “Company”, Euronext Paris: MSTY.PA and ESM of the Irish Stock Exchange: MSTY.IE), a medical device company focused on bringing to market ReActiv8®, an implantable restorative neurostimulation system to treat disabling Chronic Low Back Pain (“CLBP”), announces the first sale and implant of ReActiv8 in Ireland.

The ReActiv8 implant was performed at St. Joseph’s Hospital, part of the Beaumont Hospital Group, in Dublin, by Dr. Josh Keaveny and Dr. Alexander Moudrakovski, Consultants in Anaesthesia and Pain Medicine.

Dr. Keaveny commented: “ReActiv8 represents a novel approach to Chronic Low Back Pain which addresses the underlying cause of the condition. We now have a new option for treating patients who have suffered from debilitating back pain for years who are not candidates for spine surgery and have attempted many other conventional therapies without adequate relief.”

ReActiv8 works by electrically stimulating the nerves responsible for contracting the key stabilizing muscles of the lumbar spine. Activation of these muscles to restore functional spine stability has been shown to facilitate recovery from Chronic Low Back Pain.

Peter Crosby, CEO of Mainstay, commented: “As part of our early commercialization strategy, we are building a network of reference sites in Europe, who can champion ReActiv8 and help expand the market. As an Irish company, Ireland is our home market, and we are pleased to partner with Dr. Keaveny and Dr. Moudrakovski to establish a foothold in our second European market following the start of commercialization in Germany.”

Mainstay received CE Marking for ReActiv8 supported by positive results from the ReActiv8-A Clinical Trial that demonstrated a clinically important, statistically significant and lasting improvement in pain, disability and quality of life in people with disabling CLBP and few other treatment options.

About Mainstay

Mainstay is a medical device company focused on bringing to market 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 and Germany, and its ordinary shares are admitted to trading on Euronext Paris (MSTY.PA) and the ESM of the Irish Stock Exchange (MSTY.IE).

About Chronic Low Back Pain

One of the recognised root causes of CLBP is impaired control by the nervous system of the muscles that dynamically stabilise 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 utilisation 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 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

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 progress and success of the ReActiv8-B Clinical Trial, general economic and business conditions, the 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, political and economic uncertainty. The forward-looking statements herein speak only at the date of this announcement.

Contacts

PR and IR Enquiries:
Consilium Strategic Communications (international strategic communications – business and trade media)
Chris Gardner, Mary-Jane Elliott, Jessica Hodgson, Hendrik Thys, +44 203 709 5700 / +44 7921 697 654
mainstaymedical@consilium-comms.com
or
FTI Consulting (for Ireland)
Jonathan Neilan, +353 1 663 3686
jonathan.neilan@fticonsulting.com
or
NewCap (for France)
Louis-Victor Delouvrier, +: +33 1 44 71 98 53
lvdelouvrier@newcap.fr
or
AndreasBohne.Com/Kötting Consulting (for Germany)
Andreas Bohne, +49 2102 1485368
abo@andreasbohne.com
or
Wilhelm Kötting, +49 69 75913293
wkotting@gmail.com
or
Investor Relations:
LifeSci Advisors, LLC
Brian Ritchie, + 1 (212) 915-2578
britchie@lifesciadvisors.com
ESM Advisers:
Davy
Fergal Meegan or Barry Murphy, +353 1 679 6363
fergal.meegan@davy.ie or barry.murphy2@davy.ie

Contacts

PR and IR Enquiries:
Consilium Strategic Communications (international strategic communications – business and trade media)
Chris Gardner, Mary-Jane Elliott, Jessica Hodgson, Hendrik Thys, +44 203 709 5700 / +44 7921 697 654
mainstaymedical@consilium-comms.com
or
FTI Consulting (for Ireland)
Jonathan Neilan, +353 1 663 3686
jonathan.neilan@fticonsulting.com
or
NewCap (for France)
Louis-Victor Delouvrier, +: +33 1 44 71 98 53
lvdelouvrier@newcap.fr
or
AndreasBohne.Com/Kötting Consulting (for Germany)
Andreas Bohne, +49 2102 1485368
abo@andreasbohne.com
or
Wilhelm Kötting, +49 69 75913293
wkotting@gmail.com
or
Investor Relations:
LifeSci Advisors, LLC
Brian Ritchie, + 1 (212) 915-2578
britchie@lifesciadvisors.com
ESM Advisers:
Davy
Fergal Meegan or Barry Murphy, +353 1 679 6363
fergal.meegan@davy.ie or barry.murphy2@davy.ie