Update on Regulatory Application for ReActiv8 in Australia

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 restorative neurostimulation system to treat disabling Chronic Low Back Pain, today provides an update on its application for the admission of ReActiv8 to the Australian Register of Therapeutic Goods (ARTG), which the Company filed in January 2017.


The Therapeutic Goods Administration (TGA) has requested additional clinical data with respect to ReActiv8. To provide the most meaningful clinical data possible, we intend to rely on the clinical data being gathered as part of the ongoing ReActiv8-B clinical study. As stated previously, this clinical study is expected to be fully enrolled by the end of the second quarter of 2018, with a full data readout expected towards the end of 2018. Upon availability of the ReActiv8-B data, we plan to submit a new application to the TGA seeking admission of ReActiv8.


The Therapeutic Goods Administration may request additional information during the review process. Review of an application for admission of a product to the ARTG has varied historically. The TGA is required to complete assessment of applications within approximately one year.


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 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.mainstaymedical.com