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.
