DUBLIN--(BUSINESS WIRE)--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 that following the announcement of his appointment on September 5, 2017, Mr. Jason Hannon has today taken up his role as CEO and been appointed as a Director of Mainstay.
Mr. Hannon joins Mainstay at a critical time in the Company’s development with the dual focus of commercializing the market-changing ReActiv8 technology in Europe and beyond, while simultaneously completing the global clinical trial in support of submission for FDA approval.
Mr. Hannon said: “Mainstay has pioneered a new approach to treating chronic low back pain which seeks to help the body repair itself rather than merely masking pain. ReActiv8 is aimed at providing a new therapy for the large number of patients for whom other treatments have failed. I look forward to working with the team to maximize the potential of ReActiv8 globally and build on Mainstay’s technology platform.”
Mr. Hannon joins Mainstay having most recently served as President and Chief Operating Officer of NuVasive (NASDAQ:NUVA), a leading medical device company focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions. During his 12-year tenure at NuVasive, the company’s commercial presence was expanded globally to more than 40 countries and revenue grew from $61M to $962M.
ADDITIONAL INFORMATION:
Mr. Hannon holds 401,862 share options over the Company’s ordinary shares and, other than as set out below, there is no further information to be disclosed under schedule 2(g) and Rule 17 of the ESM Rules in respect of Mr Hannon's appointment to the board of Mainstay.
Mr Jason Marshall Hannon (aged 45) is, or has been, a director of the following companies during the previous five years:
Previous Directorships:
Nemaris, Inc.
NuVasive Austria GmbH
NuVasive Italia s.r.l.
NuVasive PR, Inc.
NuVasive Spain S.L.
MIS Spine Comercial
NuVasive Southeast Asia Pte Lte
NuVasive Ireland (NuVasive Ireland entered liquidation on 3rd November 2016. Mr Kieron Hayes has been appointed liquidator to NuVasive Ireland)
NuVasive International Technology (NuVasive International Technology entered liquidation on 22nd November 2016. Mr Kieron Hayes has been appointed liquidator to NuVasive International Technology)
NuVasive AUST/NZ Pty. Ltd
NuVasive Germany GmbH
NuVasive Japan KK
NuVasive Malaysia Sdn Bhd (dissolved)
NuVasive Netherlands B.V.
NuVasive Netherlands Cooperatief
NT International C.V.
NuVasive Poland
NuVasive LLC
NuVasive UK Limited
Cervitech, Inc. (dissolved)
NuVasive Clinical Services Monitoring, Inc.
NuVasive Clinical Services, Inc.
NuVasive Specialized Orthopedics, Inc.
NeuroMed, Inc.
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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 the ReActiv8-B Clinical Trial
The ReActiv8-B Clinical Trial is an international, multi-center, prospective randomized sham controlled blinded trial with one-way crossover conducted under an Investigational Device Exemption (IDE). The ReActiv8-B Clinical Trial is designed to generate data to form part of the Pre-Market Approval Application (PMAA) of ReActiv8 to the FDA. Further details can be found at https://clinicaltrials.gov/show/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.
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.