15th February 2018
Mainstay Medical Publishes 2017 Full Year Results
Dublin – Ireland, 15 February 2018 – 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 restorative neurostimulation system to treat disabling Chronic Low Back Pain, announces today the publication of its 2017 Full Year results and Annual Report.
- In December 2017, we announced the positive outcome of the Interim Analysis of the ReActiv8-B Study. The Independent Data Monitoring Committee recommended the continuation of the Study with a definitive size of 168 evaluable patients. The DMC also reported that they had no safety concerns in the Study.
- The ReActiv8-B Study is expected to be fully enrolled by the end of the second quarter of 2018, with a full data readout expected towards the end of 2018. The ultimate number of patients in the Study will be higher than 168 due to the nature of the enrollment process.
- Mainstay has continued to advance the initial commercialization of ReActiv8 in Europe. Our European commercial activities are initially focused on Germany, where we are working to drive adoption in a select number of high volume spine care centers to develop reference sites.
- To date, 5 centers in Germany and Ireland have implanted patients with ReActiv8, and several additional sites have been trained.
- We were recently issued a new US Patent, U.S. Patent No. 9,861,811 “Electrical Stimulator for Treatment of Back Pain and Methods of Use”, bringing the total current number of US issued patents in the Mainstay portfolio to nine.
- Revenue during the year ended 31 December 2017 was $0.3 million (2016: nil).
- Operating expenses related to on-going activities were $27.9 million during the year ended 31 December 2017 (2016: $16.8 million).
- Cash on hand as at 31 December 2017 was $10 million (2016: $36.7 million) and operating net cash outflows for the year ended 31 December 2017 were $24.9 million (2016: $16.7 million). This operating cash outflow reflects the cost of the research and development of ReActiv8, undertaking our clinical trials, commercialization expenditure, the ongoing costs of being a public company, and running the Group.
- The Company had $7.8 million cash on hand at 31 January 2018.
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Mainstay is a medical device company focused on bringing to market an innovative implantable restorative 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, Australia and Germany, and its ordinary shares are admitted to trading on Euronext Paris (MSTY.PA) and the ESM of the Irish Stock Exchange (MSTY.IE).
About Chronic Low Back Pain
One of the recognized root causes of CLBP is impaired control by the nervous system of the muscles that dynamically stabilize the spine in the low 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 utilization put a significant burden on individuals, families, communities, industry and governments.
Further information can be found at www.mainstay‑medical.com
CAUTION – in the United States, ReActiv8 is limited by federal law to investigational use only.