Mainstay Medical Announces Date for 2015 Preliminary Results

DUBLIN--()--

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.

PR and IR Enquiries:
Consilium Strategic Communications (international strategic communications – business and trade media)
Chris Gardner, Mary-Jane Elliott, Matthew Neal, 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
FTI Consulting (for France)
Astrid Villette, +33 1 47 03 69 51
Astrid.Villette@fticonsulting.com
or
Investor relations:
The Trout Group LLC
Jillian Connell, +1 646 378 2956 / +1 617 309 8349
jconnell@troutgroup.com
or
ESM Advisers:
Davy
Fergal Meegan or Barry Murphy, +353 1 679 6363
fergal.meegan@davy.ie or barry.murphy2@davy.ie

Category Code: NOR
Sequence Number: 508520
Time of Receipt (offset from UTC): 20160202T230021+0000

Contacts

Mainstay Medical Intl. PLC

Contacts

Mainstay Medical Intl. PLC