DUBLIN--(BUSINESS WIRE)--Regulatory News:
Mainstay Medical International plc (BOURSE:MSTY) (“Mainstay” or the “Company” listed on Euronext Paris: MSTY.PA and ESM of the Irish Stock Exchange: MSTY.IE) announces that it will release its 2015 Preliminary Results on Monday, 8 February, 2016 at 07:00am GMT.
The results press release will be available on the “Investors” section of the Mainstay Medical website at: http://www.mainstay-medical.com/investors.
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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 and Australia, and is listed on Euronext Paris (MSTY.PA) and the ESM of the Irish Stock Exchange (MSTY.IE).
About the ReActiv8-A Trial
The ReActiv8-A clinical trial is a prospective single arm clinical trial with up to 96 subjects at sites in Australia and Europe. Data from the first 47 subjects in ReActiv8-A Trial have been submitted as part of an application for CE Marking. Further details can be obtained at https://clinicaltrials.gov/show/NCT01985230.
About the ReActiv8-B Trial
The ReActiv8-B Clinical Trial is an international, multi-centre, prospective randomized sham controlled blinded trial with one-way crossover conducted under an Investigational Device Exemption (IDE). The purpose of the ReActiv8-B Clinical Trial is to gather 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 recognised root causes of CLBP is disruption of control by the nervous system of the muscles that dynamically stabilise the spine in the lower back, and an unstable spine can result in 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 CLBP 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
ReActiv8 is an investigational device and is not approved for commercialisation anywhere in the world.
CAUTION – in the United States, ReActiv8 is limited by federal law to investigational use only.