Dublin – Ireland - 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 the development and commercialization of a novel neurostimulation therapy for people suffering from debilitating Chronic Low Back Pain (CLBP), today announced the issuance of two new U.S. Patents:
• U.S. Patent No. 9,072,897 entitled “Systems and Methods for Restoring Muscle Function to the Lumbar Spine”
• U.S. Patent No. 9,079,019 entitled “Apparatus and Methods for Anchoring Electrode Leads for Use with Implantable Neuromuscular Electrical Stimulator”.
Corresponding applications have been made in other countries. Mainstay continues to add to its portfolio of issued patents and pending applications.
Most people with CLBP have exhausted conventional treatments, are not candidates for surgery or spinal cord stimulation, and in the prime of their lives face a future of continuing pain and disability. For many of these people the root cause of their CLBP is a disruption in the control of the muscles that stabilize the lumbar spine. ReActiv8’s unique approach is to use electrical stimulation to elicit repetitive contractions of the key stabilising muscles of the lumbar spine to reactivate the body’s control over these muscles allowing recovery from CLBP.
Peter Crosby, Mainstay’s Chief Executive Officer, commented: “Our approach to the treatment of CLBP in this challenging population is unique. We are proud of our intellectual property portfolio, and look forward to continued development of the portfolio in the coming years.”
Clinical trials with ReActiv8 are ongoing in Europe and Australia, and the Company recently announced FDA approval to start a clinical trial of ReActiv8 under an Investigational Device Exception (IDE).
Mainstay is a medical device company which is developing an innovative implantable neurostimulation medical device, ReActiv8®, for people with disabling Chronic Low Back Plan (CLBP). Low Back Pain is a leading cause of activity limitation and work absence throughout much of the developed world, imposing a high economic burden on individuals, families, communities, industry, and governments.
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 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 economies.
Further information can be found at www.mainstay-medical.com
ReActiv8 is an investigational device and is not approved for commercialisation anywhere in the world. CAUTION – in the United States, ReActiv8 is limited by federal law to investigational use only.