Transformative, non-drug treatment offers new solution for country’s underserved depression sufferers
MALVERN, Pa., June 03, 2019 (GLOBE NEWSWIRE) -- Neuronetics, Inc. (STIM), a commercial stage medical technology company focused on designing, developing and marketing products that improve the quality of life for patients who suffer from psychiatric disorders, announced today that Japan's Ministry of Health, Labour and Welfare (MHLW) listed reimbursement for the Company’s NeuroStar® Advanced Therapy System for the treatment of Major Depressive Disorder (MDD) in adults. MHLW and Japan's Central Social Insurance Medical Council (Chuikyo) approved reimbursement earlier this year and the listing is effective as of June 1, 2019.
Reimbursement of NeuroStar Advanced Therapy, listed under Japan’s national health insurance, addresses an unmet need for patient access to care. As many as 2.5 million people are living with depression in Japan, according to the MHLW. Among the 730,000 patients who are being treated for the mental health illness, approximately 30 percent do not benefit from antidepressant medications, demonstrating the critical need for alternative depression treatments in Japan. Now, the largest inpatient and outpatient psychiatric facilities with comprehensive mental health services are permitted to offer NeuroStar Advanced Therapy to patients at the rate of JPY12,000 per session.
“Access and affordability are crucial, particularly when public health issues like mental health and depression are a growing concern and unfortunate reality for so many. We know that antidepressant medications don’t work for everyone and reimbursement approval of NeuroStar Advanced Therapy in Japan means that patients suffering from depression who aren’t achieving relief may be able to find hope with access to this safe and effective non-drug treatment,” said Chris Thatcher, President and CEO of Neuronetics. “This is an exciting step forward, as we remain dedicated to improving global access to, and affordability of, this treatment that has the power to transform lives.”
With more than 2.3 million treatments delivered to more than 66,000 patients worldwide, NeuroStar Advanced Therapy is a proven treatment that uses magnetic pulses to stimulate areas of the brain that are underactive in depression.1,2 It was the first TMS device to receive FDA clearance in the United States in 2008, and the first such device to be approved in Japan by the Pharmaceuticals and Medical Devices Agency (PMDA) for marketing and sale in 2017. The NeuroStar Advanced Therapy System is exclusively distributed in Japan by Teijin Pharma Limited.
In addition to providing the highest standard of care to an underserved population of patients suffering from depression, NeuroStar Advanced Therapy device operators in Japan are required to participate in TMS practical training sessions held by both the Japanese Society of Psychiatry and Neurology, and Teijin Pharma.
Neuronetics, Inc. is a commercial-stage medical technology company focused on designing, developing, and marketing products that improve the quality of life for patients who suffer from psychiatric disorders. Our first commercial product, the NeuroStar® Advanced Therapy System, is a non-invasive and non-systemic office-based treatment that uses transcranial magnetic stimulation, or TMS, to create a pulsed, MRI-strength magnetic field that induces electrical currents designed to stimulate specific areas of the brain associated with mood. The system is cleared by the United States Food and Drug Administration, or FDA, for the treatment of major depressive disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode. Additional information can be found at www.neuronetics.com.
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 TMS choice of doctors for patients with MDD in the United States, and is widely available across the United States.
NeuroStar is widely reimbursed by most commercial and government health plans in the United States, 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.
NeuroStar 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).3 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.
Statements in the press regarding Neuronetics, Inc. (the “Company”) that are not historical facts constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements may be identified by terms such as “outlook,” “potential,” “believe,” “expect,” “plan,” “anticipate,” “predict,” “may,” “will,” “could,” “would” and “should” as well as the negative of these terms and similar expressions. These statements include those relating to: expectations regarding NeuroStar Advanced Therapy treatment by psychiatrists and facilities in Japan; the Company’s expectations regarding growth opportunities and the build out of its NeuroStar Advanced Therapy System platform; expectations or beliefs regarding future events, potential markets or market size, and technological developments; and any statements of assumptions underlying any of the foregoing items. These statements are subject to significant risks and uncertainties and actual results could differ materially from those projected. The Company cautions investors not to place undue reliance on the forward-looking statements contained in this release. These risks and uncertainties include, without limitation, risks and uncertainties related to: continued availability and adequacy of coverage and reimbursement from third-party payors for treatments using the Company’s products; physician and patient demand for treatments using the Company’s products; developments in respect of competing technologies and therapies for the indications that the Company’s products treat; product defects; the Company’s ability to obtain and maintain intellectual property protection for its technology; and developments in regulation in the United States, Japan and other applicable jurisdictions. For a discussion of these and other related risks, please refer to the Company’s recent SEC filings which are available on the SEC’s website at www.sec.gov. These forward-looking statements are based on the Company's expectations and assumptions as of the date of this press release. Except as required by law, the Company undertakes no duty or obligation to update any forward-looking statements contained in this press release as a result of new information, future events or changes in the Company's expectations.
Mark R. Klausner
Leanne Scott Brown
1 Post A, et al. (2001) J Psychiatric Research. 35:193-215
2 Liston C, et al. (2014) Biol Psychiatry. 76(7):517-26
3 George MS, et al. Arch Gen Psychiatry, (2010)