- ReActiv8-B Clinical Trial advancing well – enrollment on track to complete around end 2017
- Initial commercialization of ReActiv8 in Europe is underway
- Cash on hand at 30 June 2017 – $24.5 million
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 (CLBP), today announces the publication of its report for the Half Year ended 30 June 2017.
Peter Crosby, CEO of Mainstay, commented: “The ReActiv8-B Clinical Trial is a key step towards commercialization in the US, our most significant target market. The Trial is advancing well, and the enrollment rate has been accelerating as the number of active sites increased during 2017, and based on our experience to date, we anticipate enrollment will complete around the end of 2017, with results available in 2018.
“Meanwhile, we have begun commercialization of ReActiv8 in Europe. Following the first sale and implant in early 2017, our initial customers are gaining experience with ReActiv8 and we are working with them to help integrate it into their clinical routine. We continue to advance our strategy of targeting key reference centers in Germany, and then building on that experience and data from the ReActiv8-B Trial to expand commercialization to additional centers and other countries.”
Business Update:
- The ReActiv8-B Clinical Trial is an international, multi-center, prospective randomized sham-controlled triple blinded trial with one-way crossover, conducted under an Investigational Device Exemption (IDE) from the US Food and Drug Administration (FDA). It is intended to gather data in support of an application for pre-market approval (PMA) from the FDA, a key step towards the commercialization of ReActiv8 in the US. Information about the trial can be found at https://clinicaltrials.gov/ct2/show/study/NCT02577354.
During 2017, we have continued to advance the ReActiv8-B Clinical Trial and over half the required number of implants have now been performed.
- In February 2017, we announced the first sale and implant had been performed at the Catholic Hospital Koblenz-Montabaur in Koblenz, Germany. We are focusing commercialization of ReActiv8 initially on Germany, where we aim to drive adoption of ReActiv8 in a select number of high volume multi-disciplinary spine care centers. As our pioneering customers are gaining more experience with the ReActiv8 therapy we are working with them towards the goal of making ReActiv8 part of their routine clinical practice. We are progressing discussions with other key centers in Germany, and implanter training for these centers is underway. Our strategy is to work with key reference centers in Germany, and then build on that experience and data from the ReActiv8-B Trial to expand commercialization to additional centers and other countries.
More recently, in May 2017, we announced that commercialization has begun in Ireland, Mainstay’s home market.
Financial Update:
- Revenue during the six-month period ending 30 June 2017 was $0.25 million.
- Operating expenses were $12.3 million ($8.0 million in 1H16) and the increase is driven by the ramp up of enrollments and implants in the ReActiv8-B Trial, and expenditure arising on sales activities (which commenced in 2017).
- Cash on hand at 30 June was $24.5 million, and operating cash outflows for the period were $11.4 million.
About Mainstay
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 the ReActiv8-B Clinical Trial
The ReActiv8-B Clinical Trial is an international, multi-center, prospective randomized sham controlled blinded trial with one-way crossover conducted under an Investigational Device Exemption (IDE). The ReActiv8-B Clinical Trial is designed to generate data to form part of the Pre-Market Approval Application (PMAA) of ReActiv8® to the FDA. Further details can be found at https://clinicaltrials.gov/show/NCT02577354
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