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Press Release

Half-year Report

MDxHealth
Posted on: 23 Sep 16

DUBLIN--(BUSINESS WIRE)--

Mainstay Medical Announces Half Year Financial Results

Mainstay Medical International plc (“Mainstay”, “We” 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 neurostimulation system to treat disabling Chronic Low Back Pain (“CLBP”), today announces the publication of its report for the Half Year ended 30 June 2016.

Highlights

On 14 September 2016, Mainstay announced the enrollment of the first subject in the ReActiv8-B Clinical Trial. The purpose of the ReActiv8-B Clinical Trial is to gather data in support of an application for pre-market approval (“PMA”) from the US Food and Drug Administration (“FDA”), a key step towards commercialization of ReActiv8 in the US. The Clinical Trial, if successful, will provide Level 1 Evidence of efficacy of ReActiv8, which may be used to support applications for favorable reimbursement in the USA. In addition, evidence from the ReActiv8-B Clinical Trial will be used to support market development activities worldwide.

On 25 May 2016, Mainstay announced the receipt of CE Marking approval for ReActiv8. The CE Marking approval is based on positive results from the ReActiv8-A Clinical Trial which demonstrated clinically important, statistically significant and lasting improvement in pain, disability and quality of life in people with disabling chronic low back pain and few other treatment options. On 20 September 2016 we announced the one-year results from the ReActiv8-A Clinical Trial, which showed long term sustained performance.

Our commercial launch of ReActiv8 is focused on Germany. We aim to drive adoption of ReActiv8 in a select number of hospitals with a large population of patients with chronic low back pain and with a multi-disciplinary approach to treatment. Our initial customers in Germany (neurosurgeons and orthopedic spine surgeons) have been trained, contract negotiations are well under way, and ethics committee submissions have been made for the ReActiv8-C Registry. We have recruited a direct sales force, which is supported by our team of experienced field clinical specialists. As we gain experience and momentum, we will expand our commercialization efforts to other countries and centers.

On 17 June 2016, Mainstay announced the completion of a private placement of €30 million (approximately $33.7 million) through a placement of 2,307,694 new ordinary shares with new and existing shareholders.

In February 2016, a new US Patent was issued bringing the total number of issued US Patents in the Mainstay portfolio to seven.

Operating expenses were $8.0 million ($6.3 million in 1H15) and the increase was primarily driven by expansion of our team, preparation for the ReActiv8-B Clinical Trial and preparation for our commercial launch.

Cash on hand at 30 June was $42.8 million and operating cash out flows for the period were $7.5 million.

About Mainstay

Mainstay is a medical device company focused on bringing to market an innovative implantable 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).

CAUTION – in the United States, ReActiv8 is limited by federal law to investigational use only.

About the ReActiv8-C Registry

The ReActiv8-C Registry is an international, multi-center, data collection registry. All patients who will be implanted with ReActiv8 during commercialization will be invited to enroll in the ReActiv8-C Registry until the target enrollment numbers have been reached. The purpose is to gather additional summary data on the long term performance of ReActiv8 in at least 50 patients.

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

The Company will host a live conference call for analysts and investors at 3:00pm Dublin time (4:00pm Paris, 10:00am New York) on the day. The call will be conducted in English and a replay will be available for 30 days.

Dial-ins for the call are outlined below:

 Ireland Toll Free Number: 1800 931 806

France Toll Free Number:0805 111 542

Finland Toll Free Number:0800 778 968

Netherlands Toll Free Number:0800 023 3590

Germany Toll Free Number:0800 101 4051

USA Toll Free Number:1866 793 4273

International Non Toll Free Number:+44 203 425 3098

Passcode:

849195#

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.

Half Year Report 2016

Mainstay Medical International plc and its subsidiaries

Half Year Report comprising Interim Management Report and condensed consolidated Financial Statements for the half year ended 30 June 2016

Mainstay Medical International plc

Table of contents

Corporate and shareholder information   3

Interim Management Report4

Directors’ Responsibilities Statement7

Condensed consolidated statement of profit or loss and other comprehensive income8

Condensed consolidated statement of financial position9

Condensed consolidated statement of changes in shareholders’ equity10

Condensed consolidated statement of cash flows11

Notes to the condensed consolidated Financial Statements12

Forward looking statements

This Report 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 Report 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 Report. 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 Report, 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 Report.

Mainstay Medical International plc

Corporate and shareholder information

Directors Oern Stuge MD, Independent Non-Executive Chairman

Peter Crosby, Chief Executive Officer and Executive Director

David Brabazon, Independent Non-Executive Director

Greg Garfield, Non-Executive Director

Nael Karim Kassar, Non-Executive Director

Antoine Papiernik, Non-Executive Director

James Reinstein, Independent Non-Executive Director

Manus Rogan PhD, Non-Executive Director

Dan Sachs MD, Non-Executive Director

 

SecretaryTom Maher

 

Registered officeClonmel House

Forster Way

Swords, K67F2K3

County Dublin, Ireland

 

Registered number

     539688

 

Website

www.mainstay-medical.com

 

ISIN / SymbolIE00BJYS1G50 / MSTY.PA (Paris) and MSTY.IE

 

Legal AdvisorsMcCann FitzGerald

Riverside One

Sir John Rogerson’s Quay

Dublin 2, Ireland

 

Jones Day

2, rue Saint-Florentin

75001 Paris, France

 

Independent AuditorKPMG

Chartered Accountants

1 Stokes Place

St Stephen’s Green

Dublin 2, Ireland

 

Principal BankersHSBC

Bank of Ireland

 

ESM Adviser and BrokerJ&E Davy

Davy House

49 Dawson Street

Dublin 2, Ireland

 

RegistrarComputershare Investor Services (Ireland) Limited

Heron House

Corrig Road

Sandyford Industrial Estate

Dublin 18, Ireland

 

Paying Agent (in France)Caceis Corporate Trust

1/3, Place Valhubert

75013 Paris

France

For more information:
www.businesswire.com/news/home/20160921006624/en/Mainstay-Medical-UK-Regulatory-Announcement-Half-year-Report

Editor's Details

Mike Wood
PharmiWeb.com
www.pharmiweb.com
editor@pharmiweb.com

Last updated on: 23/09/2016

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