Application for inclusion in Australian Register of Therapeutic Goods a key step towards commercialization of innovative treatment of Chronic Low Back Pain in Australian market
Dublin, Ireland - 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 neurostimulation system to treat disabling Chronic Low Back Pain (“CLBP”), announces that it has applied for ReActiv8 to be admitted to the Australian Register of Therapeutic Goods (ARTG) which would allow for commercialization in Australia.
Mainstay’s ARTG application includes the results of the ReActiv8-A Clinical Trial, which showed clinically important, statistically significant, and lasting improvement in pain, disability, and quality of life for people with Chronic Low Back Pain and limited treatment options.
Peter Crosby, CEO of Mainstay, said: “This application for approval to sell ReActiv8 in Australia is another step on our path to commercializing ReActiv8 in major world markets, adding to our initial commercialization activities in Germany and plans for other European markets. We are also making good progress with the ReActiv8-B Trial to gather data for an application for US marketing approval.”
The Therapeutic Goods Agency will review the application and may request additional data during the review process. Subject to successful ATRG registration and reimbursement, Mainstay plans to establish its own direct sales force to market ReActiv8 in Australia.
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).
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 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 utilisation 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.
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