Mainstay Medical Announces Attendance at American Association of Neurological Surgeons (AANS) Annual Meeting

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Dublin, Ireland – (COMMERCIAL THREAD) – Mainstay Medical Holdings plc today announced its attendance at the American Association of Neurological Surgeons (AANS) Annual Scientific Meeting, to be held virtually August 21-25, 2021. Mainstay Medical’s attendance will focus on ReActiv8®, its implantable restorative neurostimulation ™ to treat intractable chronic low back pain. Notably, the abstract presentation titled “Long-Term Durability of Restorative Neurostimulation for Chronic Mechanical Low Back Pain – Results from Two-Year Pivotal Trials” by Dr. Chris Gilligan, was shortlisted for the William H. Sweet Young Award. Investigators.

Mainstay Medical will also sponsor a virtual event regarding ReActiv8 with an interactive panel. The session titled “Targeting the Multifidus: A Paradigm Shift in Treatment Options” will take place on August 23, 2021 from 1:00 p.m. to 2:00 p.m. ET and is accessible through the AANS conference website at https: // virtual2021. .aans.org /. Panelists include Dr Chris Shaffrey, Dr Juan Uribe, Dr Steven Falowski, Dr Chris Gilligan and Dr Robert Levy.

Regarding the William H. Sweet Young Investigators Award, Dr Chris Gilligan, head of the division of pain medicine, department of anesthesiology, perioperative and pain medicine, Brigham & Women’s Hospital, and assistant professor of anesthesia, Harvard Medical School, said “I am honored to receive this award and to have the opportunity to share long-term data from the pivotal ReActiv8-B clinical trial, where I was a principal investigator. I am delighted to inform my colleagues about this new restorative therapy and the convincing results for patients. ReActiv8 has the potential to change the treatment paradigm for people with chronic mechanical low back pain.

“We are delighted to present ReActiv8 to AANS members”, said Jason Hannon, CEO of Mainstay Medical. “With a mechanism of action intended to restore motor control of the multifidus muscle and thereby relieve pain in unoperated patients with severe mechanical CLBP, ReActiv8 is extremely well suited for neurosurgery practice. Because historically no proven long-term treatment has been available for these patients, we look forward to the AANS community finding out about the long-term results we have achieved with ReActiv8 in multiple clinical studies.

About Mainstay Medical

Mainstay Medical is a medical device company focused on commercializing an innovative implantable restorative neurostimulation ™ system, ReActiv8®, for people suffering from disabling mechanical chronic low back pain (LCBP). Mainstay Medical is headquartered in Dublin, Ireland, and has subsidiaries operating in Ireland, the United States, Australia, Germany and the Netherlands.

About ReActiv8®

ReActiv8 is an active implantable medical device designed to treat adults with chronic intractable low back pain associated with dysfunction of the lumbar multifidus muscle, a key stabilizing muscle of the lower back, as evidenced by imaging or physiological tests in adults who have failed treatment (including pain relievers and physiotherapy) and are not candidates for spine surgery. ReActiv8 provides bilateral electrical stimulation to the medial L2 branch of the dorsal ramus nerve as it passes through the transverse process at L3. Stimulation of this nerve that supplies the multifidus muscle causes the muscle to contract which can lead to restoration of control over time, allowing the back to recover from chronic low back pain.

ReActiv8 has a CE mark allowing marketing in the European Economic Area. ReActiv8 has also been admitted to the Australian Therapeutic Products Registry (ARTG), allowing marketing throughout Australia, and has been approved for inclusion on the list of prosthetic products reimbursed in Australia, effective July 1, 2020. The list of prostheses identifies implantable devices. eligible for reimbursement from all private health insurance funds in Australia. In the United States, ReActiv8 is approved by the FDA and Mainstay Medical launched the ReActiv8 system commercially in the summer of 2021.

About chronic low back pain

One of the root causes of chronic low back pain is the impaired control by the nervous system of the muscles that dynamically stabilize the spine. ReActiv8® is designed to electrically stimulate the nerves responsible for the contraction of these muscles in order to improve the dynamic stability of the spine, allowing an improvement in chronic low back pain and its disabling effects.

People with chronic low back pain typically have a dramatically reduced quality of life and significantly higher scores on the pain, disability, depression, anxiety, and sleep disturbance scales. Their pain and disability may persist despite the best medical treatments available, and only a small percentage of cases result from an identified pathology or anatomical defect that can be corrected with spinal surgery. Their ability to work or be productive is severely affected by their CLBP, and lost work days, disability benefits and the resulting use of health resources, place a significant burden on individuals, families, workers and others. communities, industry and governments.

Further information can be found at www.mainstaymedical.com.

Forward-looking statements

This announcement includes statements that are or may be considered to be forward-looking statements identified through the use of forward-looking terminology, including the terms “anticipates”, “believes”, “believes”, “expects”, “ intends “,” may “,” plans “,” projects “,” should “,” will “or” explore “, or, in each case, their negative, other variations or comparable terminology, or in the framework for discussions of strategy, plans, objectives, objectives, future events or intentions. These forward-looking statements include all matters which are not historical facts. They appear throughout this announcement and include, without limitation, statements regarding: the Company’s current intentions, beliefs or expectations regarding, among other things, the Company’s marketing of ReActiv8 in the United States, in the UK, Australia and elsewhere; the commercial performance of ReActiv8; and operating results, financial condition, outlook, financing strategies, product design and development expectations, regulatory applications and approvals, repayment terms, costs to sell and market penetration. market and other business performance of the company.

By their nature, forward-looking statements involve risks and uncertainties as they relate to future events and circumstances. Forward-looking statements are not guarantees of future performance, and actual results may differ materially from those described or suggested by the forward-looking statements contained in this announcement. In addition, even if future results and developments are consistent with the forward-looking statements contained in this announcement, these results or developments may not be indicative of the results or developments of subsequent periods. A number of factors could cause the results and developments of the company to differ materially from those expressed or implied by the forward-looking statements contained herein, including, without limitation, the launch and successful commercialization of ReActiv8, general economic and business conditions, global medical device market conditions, industry trends, competition, availability and cost of capital, changes in law or regulation, changes in tax regimes, the time required to start and complete clinical trials, the time and process required to obtain regulatory approvals, currency fluctuations, changes in the company’s business strategy, and political and economic uncertainty. The forward-looking statements herein speak only as of the date of this announcement.


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