Dublin, Ireland – 9 November 2015: 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 neurostimulation system to treat disabling Chronic Low Back Pain, today issues this Interim Management Statement covering the period from 1 July 2015 to today’s date.
Business Update
On 2 November 2015, the Company announced it had submitted an application for a CE Mark for ReActiv8. The submission represents a further key step towards commercialisation of ReActiv8 in Europe. Mainstay’s application for CE Mark includes the results of the ReActiv8-A Clinical Trial, which were announced by the Company on 31 August 2015.
The results of the ReActiv8-A Clinical Trial showed clinically important, statistically significant, and lasting improvement in pain, disability, and quality of life for people with Chronic Low Back Pain and limited treatment options. The Clinical Results announcement is available on the Company’s website at http://www.mainstay-medical.com/news/press_releases.
On 24 August 2015, Mainstay announced the closing of debt financing for up to $15 million. The secured debt facility is non-dilutive to existing shareholders, and is provided by IPF Partners, a leading financing provider focused on the European healthcare sector. The announcement and details of the financing are available on the Company’s website at http://www.mainstay-medical.com/news/press_releases.
In July and August 2015, Mainstay announced the issuance of three new U.S. Patents.
Financial Update
There have been no significant changes in the financial position of the Company since publication of the Half Year Report for the period ended 30 June 2015. The Company had $14.0 million cash on hand at 30 September 2015.
Outlook
Mainstay looks forward to continuing to work towards obtaining CE Mark for ReActiv8, commencing commercialisation in Europe, and to progressing the US clinical trial, ReActiv8-B, a summary of which can be found at https://clinicaltrials.gov/show/NCT02577354.
About Mainstay
Mainstay is a medical device company which is developing 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 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 lower 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
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