The use of ReActiv8 neurostimulatory therapy it is recommended in the National Health Service; special arrangements will allow patients greater access to ReActiv8
DUBLIN, September 23, 2022–(BUSINESSWIRE)–Mainstay Medical Holdings plc today announces that the National Institute for Health and Care Excellence (NICE), a public agency of the Department of Health that conducts evidence-based assessments of health technologies by part of independent committees, has issued a favorable recommendation for the use of ReActiv8® Restorative Neurostimulation™ in the UK National Health Service, with special provisions for clinical management, consent and audit or investigation. ReActiv8 is currently the only technology to offer restorative neurostimulation on the NHS for mechanical refractory chronic low back pain.
“UK clinicians are among those with the most extensive experience with ReActiv8 globally. We thank NICE for recognizing this experience, as well as the significant global body of evidence we have assembled to demonstrate the efficacy and safety of this innovative therapy,” said Jason Hannon, CEO of Mainstay Medical. “This new recommendation will allow patients to have broader access to this therapy, where other therapeutic options have proven ineffective. We look forward to helping clinicians across the UK continue to improve patient outcomes.”
“Historically, therapies for chronic mechanical low back pain were aimed only at treating the symptoms, meaning the pain associated with this condition,” says Dr Ganesan Baranidharan, Consultant in Anesthesia and Pain Medicine, Leeds Teaching Hospitals NHS Trust . “As far as I know, ReActiv8 is the only therapy available that enables patients who have been suffering from chronic low back pain for several years to reverse the disease and restore their condition effectively and lastingly. ReActiv8 targets the cause of chronic mechanical low back pain, not just the symptoms. NICE’s recommendation is a huge victory for patients and clinicians, and further confirms the positive results we have seen in patients so far. This new recommendation will allow more patients to have access to ReActiv8 in the UK and beyond.”
ReActiv8 is an implantable medical device designed for the treatment of adults with chronic incurable low back pain associated with multifidus muscle dysfunction. Multifidus muscle dysfunction can be diagnosed by imaging or physiological tests in adults for whom treatments have failed, including pain medications and physical therapy, and for whom spinal surgery is not recommended. ReActiv8 has obtained regulatory authorizations in multiple geographies. The device is available in the European Economic Area, Australia, the United Kingdom, and the United States.
About Mainstay Medical
Mainstay Medical is a medical device company specializing in the commercialization of its innovative Restorative Neurostimulation™ implantable system, ReActiv8®, aimed at people suffering from chronic mechanical disabling low back pain. Mainstay Medical is headquartered in Dublin, Ireland, with subsidiaries in Ireland, the United States, Australia, Germany and the Netherlands.
For more information, visit www.mainstaymedical.com.
Forward Looking Statements
All statements contained in this document, other than statements of historical fact, are or may be considered forward-looking statements. These forward-looking statements may include, but are not limited to, statements about the Company’s current intentions, beliefs or expectations regarding, among other things, the Company’s business performance and endeavors, including the use of ReActiv8 therapy by physicians and patients in the UK. and elsewhere, and its financial condition, financing strategies, product design and development activities, regulatory applications and approvals, and reimbursement arrangements.
Forward-looking statements involve risks and uncertainties and are not guarantees of future performance. Actual results may differ materially from those described or indicated in forward-looking statements. A variety of factors could cause actual results and developments to differ materially from those expressed or implied by the forward-looking statements in this release, including, without limitation, the risks and uncertainties discussed in the company’s annual report for the fiscal year which ended in December. January 31, 2021, which should be viewed in conjunction with the Company’s public statements (available on the Company’s website at www.mainstaymedical.com). Forward-looking statements speak only as of the date of this announcement.
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