Mainstay Medical International plc (“Mainstay”, “We” 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 neurostimulation system to treat disabling Chronic Low Back Pain (“CLBP”), today announces the publication of its report for the Half Year ended 30 June 2016.
Highlights
- On 14 September 2016, Mainstay announced the enrollment of the first subject in the ReActiv8-B Clinical Trial. The purpose of the ReActiv8-B Clinical Trial is to gather data in support of an application for pre-market approval (“PMA”) from the US Food and Drug Administration (“FDA”), a key step towards commercialization of ReActiv8 in the US. The Clinical Trial, if successful, will provide Level 1 Evidence of efficacy of ReActiv8, which may be used to support applications for favorable reimbursement in the USA. In addition, evidence from the ReActiv8-B Clinical Trial will be used to support market development activities worldwide.
- On 25 May 2016, Mainstay announced the receipt of CE Marking approval for ReActiv8. The CE Marking approval is based on positive results from the ReActiv8-A Clinical Trial which demonstrated clinically important, statistically significant and lasting improvement in pain, disability and quality of life in people with disabling chronic low back pain and few other treatment options. On 20 September 2016 we announced the one-year results from the ReActiv8-A Clinical Trial, which showed long term sustained performance.
- Our commercial launch of ReActiv8 is focused on Germany. We aim to drive adoption of ReActiv8 in a select number of hospitals with a large population of patients with chronic low back pain and with a multi-disciplinary approach to treatment. Our initial customers in Germany (neurosurgeons and orthopedic spine surgeons) have been trained, contract negotiations are well under way, and ethics committee submissions have been made for the ReActiv8-C Registry. We have recruited a direct sales force, which is supported by our team of experienced field clinical specialists. As we gain experience and momentum, we will expand our commercialization efforts to other countries and centers.
- On 17 June 2016, Mainstay announced the completion of a private placement of €30 million (approximately $33.7 million) through a placement of 2,307,694 new ordinary shares with new and existing shareholders.
- In February 2016, a new US Patent was issued bringing the total number of issued US Patents in the Mainstay portfolio to seven.
- Operating expenses were $8.0 million ($6.3 million in 1H15) and the increase was primarily driven by expansion of our team, preparation for the ReActiv8-B Clinical Trial and preparation for our commercial launch.
- Cash on hand at 30 June was $42.8 million and operating cash out flows for the period were $7.5 million.
About Mainstay
Mainstay is a medical device company focused on bringing to market 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, 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).
CAUTION – in the United States, ReActiv8 is limited by federal law to investigational use only.
About the ReActiv8-C Registry
The ReActiv8-C Registry is an international, multi-center, data collection registry. All patients who will be implanted with ReActiv8 during commercialization will be invited to enroll in the ReActiv8-C Registry until the target enrollment numbers have been reached. The purpose is to gather additional summary data on the long term performance of ReActiv8 in at least 50 patients.
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