DUBLIN -- Mainstay Medical International plc (“Mainstay” or the “Company” listed on Euronext Paris: MSTY.PA and ESM of the Irish Stock Exchange: MSTY.IE) announces its results for the year ended 31 December 2014. Mainstay is an Irish medical device company with operations in Ireland, the United States and Australia. The Company is focused on developing an innovative implantable neurostimulation medical device, ReActiv8, for people with Chronic Low Back Pain (“CLBP”). ReActiv8® is designed to address the root cause of CLBP by helping to restore control to the muscles that dynamically stabilise the lumbar spine.
- The clinical trial of ReActiv8, the ReActiv8-A clinical trial, commenced in March 2014. The ReActiv8-A trial is a prospective single arm clinical trial with up to 96 subjects at sites in Australia and Europe. Outcome measures for the ReActiv8-A clinical trial are assessed at a three month endpoint after activation of stimulation and compared to baseline prior to implant. Further details can be obtained at https://clinicaltrials.gov/show/NCT01985230.
- The Company is pleased with the progress of the ReActiv8-A clinical trial. Over 40 subjects have been implanted in the ReActiv8-A clinical trial and the Company believes that data from these subjects may be sufficient to apply for a CE Mark. The Company plans to announce data from the ReActiv8-A clinical trial after the outcome data from all implanted subjects are available, audited and adjudicated.
- We are pleased to announce that more complete data of the Mainstay Sponsored Feasibility study have now been published in the peer reviewed journal, Neuromodulation. This study, which commenced in 2011, evaluated the therapy which is now delivered by ReActiv8 and summary data were reported previously. The paper is available to subscribers or for purchase from the journal.
- In January 2015, the Company submitted an application to the US Food and Drug Administration (“FDA”) for approval to start a clinical trial of ReActiv8 under an Investigational Device Exemption (an “IDE”). The Company anticipates that there will be multiple interactions with the FDA to develop a clinical trial that meets the needs of the Company, the FDA and the people who could potentially benefit from ReActiv8.
- In December 2014, the Company announced that it had achieved certification of its Quality Management System in compliance with the international quality standards ISO 13485:2003 and EN ISO 13485:2012. This certification is a necessary requirement prior to obtaining CE Mark approval of ReActiv8.
- The Company continues to expand its intellectual property portfolio, and additional patents were filed during 2014.
- On 2 May 2014, the Company completed an initial public offering (“IPO”), listing its ordinary shares on the ESM of the Irish Stock Exchange and Euronext Paris. Proceeds of $20.9 million (net of costs) were raised by way of the IPO.
- Operating expenses were $11.1 million during 2014 and have increased by $2.7 million compared to 2013 due to increased costs associated with the ReActiv8-A clinical trial, and the expansion of our team.
- Cash on hand at 31 December 2014 was $18.3 million and operating cash out flows for 2014 were $11.4 million.
Mr. Peter Crosby, Mainstay’s Chief Executive Officer, commented, “2014 has been a significant year for Mainstay, with the milestones achieved being a testament to the diligence and focus of the team. The successful IPO has allowed us to progress our ReActiv8-A clinical trial as planned in Australia and Europe. Study investigators continue to express enthusiasm for ReActiv8 and its potential to help the large population suffering from chronic low back pain. The submission of the IDE application to start a US clinical trial of ReActiv8 is a key milestone towards commercialisation of ReActiv8 in the US market.”
Mainstay is a medical device company which is developing an innovative implantable neurostimulation medical device, ReActiv8, for people with CLBP. Low Back Pain is a leading cause of activity limitation and work absence throughout much of the developed world, imposing a high economic burden on individuals, families, communities, industry, and governments. 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 economies.
Further information can be found at www.mainstay-medical.com
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