Dublin, Ireland – 31 August 2015: Mainstay Medical International plc (“Mainstay” or the “Company” listed on Euronext Paris: MSTY.PA and ESM of the Irish Stock Exchange: MSTY.IE), a medical device company focused on bringing to market ReActiv8®, a new implantable neurostimulation system to treat disabling Chronic Low Back Pain (“CLBP”), today announced the publication of its report for the half year ended 30 June 2015.
Highlights
• On 31 August 2015, the Company announced positive clinical results of the ReActiv8-A Clinical Trial, which the Company plans to use to support its submission for CE Mark approval, after which commercialization in Europe can commence. The detailed 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 being provided by IPF Partners, a leading financing provider focused on the European healthcare sector.
The facility can be drawn in three tranches, and an initial tranche of $4.5 million has been called. The second and third tranches can be drawn upon achievement of milestones related to progress through the CE Mark process for ReActiv8.
• In July and August 2015, Mainstay announced the issuance of three new U.S. Patents:
o U.S. Patent No. 9,072,897 entitled “Systems and Methods for Restoring Muscle Function to the Lumbar Spine”
o U.S. Patent No. 9,079,019 entitled “Apparatus and Methods for Anchoring Electrode Leads for Use with Implantable Neuromuscular Electrical Stimulator”.
o U.S. Patent No. 9,108,053 entitled “Apparatus and Methods for Rehabilitating a Muscle And Assessing Progress of Rehabilitation”
• In May 2015, Mainstay announced it had received approval from the United States Food and Drug Administration (“FDA”) to begin a clinical trial of ReActiv8 under an Investigational Device Exemption (“IDE”). The FDA approval is for the planned ReActiv8-B Clinical Trial, an international, multi-centre, prospective randomized sham-controlled trial designed to evaluate the safety and efficacy of ReActiv8 for the treatment of adults with CLBP and no prior back surgery.
The approval is to conduct the ReActiv8-B Clinical Trial at up to 40 clinical trial sites and for 128 randomized subjects to be implanted with ReActiv8 in the pivotal cohort. The IDE approval allows the Company to engage with investigators, clinical trial sites, and Institutional Review Boards (“IRBs” or “Ethics Committees”) leading towards the first subject recruitment and implant. Upon successful completion of the ReActiv8-B Clinical Trial and if the results support it, the Company plans to submit an application for a Pre-Market Approval (“PMA”) which is required to allow the start of commercialization in the United States.
• Operating expenses were $6.3 million during the period and have increased by $1.5 million compared to 1H14 due to costs associated with increased activity in the ReActiv8-A Clinical Trial, and the expansion of our team.
• Cash on hand at 30 June 2015 was $12.5 million and operating cash out flows for the period were $5.7 million.
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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 the ReActiv8-A Trial
The ReActiv8-A Clinical 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.
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.
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