Dublin, Ireland - 28 August 2014: Mainstay Medical International plc (“Mainstay” or “The Company”) (Euronext Paris: MSTY.PA and ESM of the Irish Stock Exchange: MSTY.IE) announces its results for the six month period ended 30 June 2014. Mainstay is an Irish medical device company with operations in Ireland, Australia and the United States. The Company is focused on the development and commercialisation of ReActiv8, an innovative implantable neurostimulation device designed to treat people with Chronic Low Back Pain (CLBP) by helping to restore control to the muscles that stabilise the lumbar spine.
Highlights
• Proceeds of $20.9 million (net of costs) were raised by way of an initial public offering. The funds will be used to advance clinical trials with the objective of obtaining CE mark required for the commercialisation of ReActiv8 in Europe, and to support regulatory activities in the United States in preparation for a clinical trial required for US regulatory approval.
• The ReActiv8-A clinical trial is progressing as planned. After the clinical trial started at sites in Australia, additional sites in Belgium and the United Kingdom have been added.
• A Pre-Investigational Device Exemption (“IDE”) information package for ReActiv8 was submitted to the US Food and Drug Administration (“FDA”). Following input from the FDA, the Company plans to finalise the protocol for the US clinical trial and to submit an application to the FDA to start a clinical trial under an IDE.
• Operating expenses of $4.8 million are in line with expectations.
• Cash position of $23.5 million as at 30 June 2014.
Mr. Peter Crosby, Mainstay’s Chief Executive Officer, commented, “The IPO and stock exchange listing earlier this year was a significant milestone in Mainstay’s development and we are pleased with the momentum which is building towards commercialisation of ReActiv8. The clinical trial is progressing as planned and we have submitted our pre-IDE package to the FDA. When available, ReActiv8 has the potential to change the lives of the millions of people who suffer from Chronic Low Back Pain.”
Mainstay is also pleased to announce the appointment of Tom Maher as General Counsel and Company Secretary effective from 2 September 2014. Tom brings with him a wealth of legal experience, he joins Mainstay from a large Dublin law firm where he was a partner in the Corporate Department and Co-Head of its life sciences practice. Tom also previously held the positions of General Counsel and Company Secretary at Amarin Corporation plc, a NASDAQ listed bio-pharmaceutical company, and Vice President, Legal Affairs at Elan Corporation plc. Hugh Kavanagh who currently holds the combined roles of CFO and Company Secretary continues in the role as CFO.
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