MALVERN, Pa., July 29, 2019 /PRNewswire/ — Neuronetics, Inc. (NASDAQ: STIM), the developer of NeuroStar® Advanced Therapy, the market leader in transcranial magnetic stimulation (TMS) for depression, announced today the launch of its TrakStar® Plus patient data management system. Building on the existing TrakStar Cloud™ system, this new release includes multiple features to simplify administrative tasks and enable doctors to spend more time focused on optimizing patient experience and care.
Based on feedback from physicians on the front lines of care who are actively treating patients with Major Depressive Disorder (MDD) with the NeuroStar device, these new features are focused on improving workflow, usability and access. The system now includes a new interface that is optimized for mobile phones and tablets and offers the existing desktop features in an easy-to-use, convenient modality, allowing physicians to remotely access and navigate through TrakStar Plus. Additionally, TrakStar Plus supports mobile Patient Health Questionnaire (PHQ-9) collection via a separate TrakStar Ratings site, which lets patients answer the depression screening survey in real time on a mobile device while in the office setting. Not only does this new feature mean more efficient management of PHQ-9 administration, saving valuable staff time, it also provides patients with a quick and easy method of completing these forms.
“We’re proud to offer the most advanced TMS patient and practice data management system on the market today and remain committed to listening to the clinical community to ensure we continually improve the TrakStar platform to best meet their changing needs and the needs of their patients,” said Greg Harper, Vice President of Product Development and Operations at Neuronetics. “The TrakStar Plus system was designed to allow physicians to focus on their patients instead of burdensome administrative tasks that can distract from patient care.”
In addition to offering mobile upgrades, TrakStar Plus now offers the ability to export notes, rating, and treatment data directly to many popular electronic medical records (EMR) platforms, eliminating the need for printing and scanning patient documents and saving valuable time when transferring patient reports into the EMR system.
First cleared by the FDA in 2008 as a safe and effective treatment for adult patients with MDD who have not seen success with at least one antidepressant, NeuroStar Advanced Therapy is available by prescription and typically administered daily in a doctor’s office for four to six weeks. With 5.5 million adults in the United States treated for depression and unable to achieve remission with antidepressant medication,1,2,3 NeuroStar Advanced Therapy is improving patient access to its therapy with widespread insurance coverage and enhanced scheduling convenience as the treatment can be delivered in under 19 minutes.* The non-drug, non-invasive therapy uses magnetic pulses to stimulate areas of the brain that are underactive in depression.4,5 It is not electroconvulsive therapy (ECT) and is free from side effects often associated with antidepressants and ECT.6 The treatment is backed with the most clinical studies for TMS in depression and has proven efficacy for patients with MDD.7,8,9
“Not only do I trust the ongoing technology and innovation coming out of Neuronetics, but I can rely on the company to always keep looking out for my patients’ quality of care,” said Bernadette DeMuri, MD, Medical Director of TMS Center of Wisconsin. “Being able to reduce the time my staff and I spend on administrative tasks and eliminate some of the paperwork we’re inundated with daily has a large impact on our ability to offer a more convenient experience for patients, and maximizes our face time with them, which is invaluable.”
Additional features of the new system include additions to the Outcomes Reports, allowing for greater specificity of report generation; patient list paging capabilities, enabling customers with a large patient database to display up to 100 patients per page; an electronic signature feature, allowing the attending physician or treater who administered the treatment session to electronically sign a report; an authorized insurance payments tracking feature to more closely monitor sessions; and a patient photo identification option.
About NeuroStar® Advanced Therapy
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 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.4,5 With more than 2.3 million treatments delivered to more than 66,000 patients worldwide 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.6
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 four times more likely to achieve remission compared to patients receiving sham treatment (P = 0.0173; 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®, NeuroStar® and TrakStar® are registered trademarks of Neuronetics, Inc. (NASDAQ:STIM). For more information and full safety and prescribing information, visit www.neurostar.com.
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 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 https://neurostar.com/neuronetics/.
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.
1Kessler RC, et al. JAMA, (2003)
2https://factfinder.census.gov/faces/nav/jsf/pages/index.xhtml, accessed 1/16/2018
3Gaynes BN et al., Cleveland Clinic Journal of Medicine 2008;75(1):57-66
4Post A, et al. (2001) J Psychiatric Research. 35:193-215
5Liston C, et al. (2014) Biol Psychiatry. 76(7):517-26
6Janicak PG, et al. J Clin Psychiatry, (2008)
7Carpenter LL, et al. Depress Anxiety, (2012)
8George MS, et al. Arch Gen Psychiatry, (2010)
9O’Reardon JP, et al. Biological Psychiatry, (2007)
SOURCE Neuronetics, Inc.