Neuronetics® Announces Greenbrook® TMS Installation Milestone for NeuroStar® Advanced Therapy System

MALVERN, Pa., Sept. 4, 2019 /PRNewswire/ -- Neuronetics, Inc. (NASDAQ: 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, today announced that Greenbrook TMS, a NeuroStar Advanced Therapy provider with 82 treatment centers across the U.S., has installed its 100^th NeuroStar system. This is a significant milestone in the availability of NeuroStar Advanced Therapy transcranial magnetic stimulation (TMS) treatment for patients. Greenbrook’s Matthews, NC location now joins the growing number of practices offering NeuroStar TMS.

As many as 17 million adults in the U.S. live with depression,¹ though 5.5 million adults in the U.S. with the disease do not see relief from antidepressant medications^2,3,4 — pointing to a significant need for safe and effective non-drug treatment options, such as NeuroStar.

“TMS is a valuable addition to the treatment of depression,” said Chris Thatcher, President and CEO of Neuronetics. “We remain committed to expanding access to the NeuroStar TMS treatment alongside our valued customers, such as Greenbrook, who share our mission to transform lives and help patients achieve remission from depression with proven and trusted options like NeuroStar. We congratulate Greenbrook TMS on achieving this important milestone in continuing to expand TMS to help patients seek relief from their depression.”

NeuroStar is a non-drug, non-invasive treatment that uses magnetic pulses to stimulate areas of the brain that are underactive in depression.^5,6 It offers doctors real-time feedback and delivers enhanced care with its precise and accurate targeting, providing reliable and consistent treatment and making it a best-in-class treatment option. Greenbrook has been treating patients with NeuroStar since 2011.

“Greenbrook TMS is committed to providing life-changing, drug-free treatment for depression. We provide care in communities across the country and strive to equip our doctors with the resources they need to provide the best treatment experience available,” said Bill Leonard, President and CEO of Greenbrook TMS. “We’re proud to have 100 NeuroStar devices installed throughout our centers. Neuronetics is a great partner and we are excited to work together to expand access to safe and effective depression treatment to those in need.”

Since receiving FDA clearance in 2008 as a safe and effective option for adult patients with Major Depressive Disorder (MDD), NeuroStar has been a trailblazer in the depression treatment space and is the number one TMS choice of doctors. In the last decade, more than 2.3 million NeuroStar treatments have been delivered across nearly 800 practice locations in the U.S., and its footprint continues to grow.

About NeuroStar Advanced Therapy
In the United States, NeuroStar Advanced Therapy is the market leader in transcranial magnetic stimulation (TMS), a non-invasive form of neuromodulation. NeuroStar was the first TMS device to receive United States Food and Drug Administration, or FDA, clearance in 2008 and the first to receive Shonin approval from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) in 2017 as a proven treatment for adults with MDD for whom medication has not worked. It uses magnetic pulses to stimulate areas of the brain that are underactive in depression.^5,6 With more than 2.3 million treatments delivered to more than 66,000 patients to-date, NeuroStar Advanced Therapy is the #1 TMS choice of doctors in the United States and is widely available across the United States. It is typically administered daily in a doctor’s office for 19 to 37 minutes* over four to six weeks. Unlike electroconvulsive therapy (ECT), NeuroStar is non-invasive and allows patients to resume daily activities immediately following treatment sessions. As a non-drug treatment, it is also free from systemic side effects often associated with antidepressant medications.⁷

NeuroStar is 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. Visit www.NeuroStar.com for more information about NeuroStar Advanced Therapy and click here to locate a NeuroStar doctor in the United States.

NeuroStar is also available in Japan and select other countries. NeuroStar became listed for reimbursement under Japan’s national health insurance on June 1, 2019. NeuroStar is exclusively distributed in Japan by Teijin Pharma Limited.

NeuroStar is indicated in the United States 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 4.2 times more likely to achieve remission compared to patients receiving sham treatment (P = 0.02; odds ratio = 4.05).⁸ 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.

Neuronetics® and NeuroStar® are registered trademarks of Neuronetics, Inc. (NASDAQ:STIM). For more information and full safety and prescribing information, visit www.neurostar.com. Greenbrook® is a registered trademark of Greenbrook TMS Neurohealth Centers.

About Neuronetics
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. NeuroStar is also available in other parts of the world, including Japan, where it is listed under Japan’s national health insurance. Additional information can be found at www.neuronetics.com.

Forward-Looking Statements
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: the Company’s expectations regarding the build out of and demand for its NeuroStar Advanced Therapy System, including with respect to trends in the incidence of depression, and its expectations or beliefs regarding future applications and development of the System; 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, including depression; 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.

¹ National Institute of Mental Health. (2019). Mental Health Information: Major Depression. https://www.nimh.nih.gov/health/statistics/major-depression.shtml
² Kessler RC, et al. JAMA, (2003)
³ https://factfinder.census.gov/faces/nav/jsf/pages/index.xhtml, accessed 1/16/2018
⁴ Gaynes BN et al., Cleveland Clinic Journal of Medicine 2008;75(1):57-66
⁵ Post A, et al. (2001) J Psychiatric Research. 35:193-215
⁶ Liston C, et al. (2014) Biol Psychiatry. 76(7):517-26
⁷ Janicak PG, et al. (2008) J Clin Psychiatry
⁸ George MS, et al. (2010) Arch Gen Psychiatry
*Treatment time may vary depending on a doctor’s recommendation.

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SOURCE Neuronetics, Inc.