Neuronetics announced today it has received Shonin approval by Japan’s Ministry of Health, Labor and Welfare to sell and distribute its NeuroStar Advanced Therapy system in the country.
MALVERN, Pa., Oct. 11, 2017 /PRNewswire/ -- Neuronetics, Inc., a privately held medical device company widely recognized as the market-leader in transcranial magnetic stimulation (TMS), announced today it has received Shonin approval by Japan’s Ministry of Health, Labor and Welfare to sell and distribute its NeuroStar® Advanced Therapy system in the country. NeuroStar Advanced Therapy is the first transcranial magnetic stimulation to be selected as a safe and effective non-drug treatment option for Major Depressive Disorder (MDD) in Japan. NeuroStar Advanced Therapy is a non-invasive treatment that uses MRI strength magnetic pulses to stimulate areas of the brain that are underactive in depression. It is not electroconvulsive therapy (ECT) and uses a different mechanism than ECT. Backed with the most clinical studies for TMS in depression, NeuroStar Advanced Therapy is free from side effects often associated with antidepressants.
Depression is the leading cause of ill health and disability worldwide, and in February 2017, the World Health Organization announced depression as the theme for its 2017 World Health Day campaign. With about 3 million people in Japan diagnosed with depression and the country facing one of the highest suicide rates in the world, NeuroStar Advanced Therapy allows for a new depression treatment for adult patients in Japan. Further highlighting its focus on mental wellness, Japan also recently introduced the Industrial Safety and Health Act which requires companies with 50 or more employees to offer an annual stress check to monitor employees’ mental health.
“NeuroStar Advanced Therapy’s Japanese approval and presence in the world’s second largest medical device market highlights our global leadership in addressing the need for a proven, non-drug treatment for depression,” said Chris Thatcher, CEO of Neuronetics, Inc. “Depression is a worldwide public health issue impacting more than 300 million people, and we are thrilled to further increase patient access to this transformative treatment in Japan and help more people find relief from their depression.”
With more than 1.5 million TMS treatments delivered to date to approximately 60,000 patients worldwide, NeuroStar Advanced Therapy shows proven efficacy across a broad range of treatment resistance. In an open-label clinical trial, 58 percent of patients significantly responded to treatment, and 37 percent achieved complete remission of their depression symptoms.[1] Additionally, NeuroStar Advanced Therapy’s sophisticated technology provides physicians with real-time feedback and delivers reliable and consistent treatment allowing for the right treatment dose to be delivered to the right location every time, giving patients the best possible chance for long-term remission.
In addition to its recent expansion into Japan, NeuroStar Advanced Therapy is commercially available in the United States of America as well as the Middle East and Asia regions. NeuroStar Advanced Therapy is also CE marked.
Visit www.NeuroStar.com for more information about NeuroStar Advanced Therapy.
About Neuronetics, Inc.
Neuronetics, Inc. is a privately held medical device company focused on developing non-invasive therapies for psychiatric and neurological disorders using MRI-strength magnetic field pulses. Based in Malvern, PA, Neuronetics, Inc. is the leader in transcranial magnetic stimulation (TMS) with its development of NeuroStar® Advanced Therapy, a noninvasive form of neuromodulation. For more information, please visit www.neurostar.com.
NeuroStar® is a registered trademark of Neuronetics, Inc.
About NeuroStar® Advanced Therapy
NeuroStar® Advanced Therapy is the established leader in transcranial magnetic stimulation (TMS), a non-invasive form of neuromodulation. NeuroStar Advanced Therapy is the #1 physician-preferred TMS treatment for patients with MDD, and there are over 800 NeuroStar systems in 49 states in the United States.
With over 300 million covered lives, NeuroStar is widely reimbursed by most United States commercial and government health plans, including Medicare and Tricare. In addition, there are programs in place, such as NeuroStar Reimbursement Support, to help patients and providers obtain coverage and reimbursement for NeuroStar Advanced Therapy.
In the United States, NeuroStar Advanced Therapy is indicated for the treatment of MDD in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode. In an NIMH-funded, independent, randomized controlled trial, patients treated with TMS using a clinical-trial version of the NeuroStar TMS System were four times more likely to achieve remission compared to patients receiving sham treatment (P = 0.0173; odds ratio = 4.05).[2] The most common side effect is pain or discomfort at or near the treatment site, which usually resolves within one week. It is contraindicated in people with non-removable conductive metal in or near the head.
For more information and full safety and prescribing information, visit www.neurostar.com.
[1] Carpenter LL, et al. Depress Anxiety, (2012)
[2]George MS, et al. Arch Gen Psychiatry, (2010)
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SOURCE NeuroStar Advanced Therapy
