Poster sessions will reveal findings from investigator-initiated trial using NeuroStar® Advanced Therapy TMS for PTSD and TBI and case report on early-onset Alzheimer's Disease
MALVERN, Pa., Aug. 19, 2019 /PRNewswire/ -- 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 that researchers at the Uniformed Services University of the Health Sciences will present clinical data at the 2019 Military Health System Research Symposium (MHSRS) in Kissimmee, FL from August 19-22 from an investigator-initiated trial utilizing the Company's NeuroStar® Advanced Therapy TMS research system for PTSD and traumatic brain injury (TBI). In addition, they will present a case report of one patient treated and studied for Alzheimer's Disease. MHSRS is the Department of Defense's premier scientific meeting focused on military-related research and development. The commercially available NeuroStar system is FDA-cleared in the United States for the treatment of Major Depressive Disorder (MDD) in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode.
"The investigators at Uniformed Services University using the NeuroStar system to conduct potentially life-changing research truly share our passion and commitment to transforming lives," said Chris Thatcher, President and CEO of Neuronetics. "We know that mental health challenges continue to plague millions, including those in the armed forces, and research like this is critical when it comes to making strides toward new treatment efforts to serve those who dedicate their lives to serving others."
The research, led by Paul F. Pasquina, MD, Professor and Chair of the Department of Physical Medical and Rehabilitation at Uniformed Services University of the Health Sciences and Chief of Rehabilitation Medicine Service at Walter Reed National Military Medical Center, and his colleague Mr. Jared Garland, Clinical Research Assistant at the Henry M. Jackson Foundation for the Advancement of Military Medicine in Support of the Center for Rehabilitative Sciences Research at Uniformed Services University of the Health Sciences, will be presented by Mr. Garland in two poster sessions at the symposium highlighting their NeuroStar system research and future implications of the innovative technology.
- Wednesday, August 21, 2019 at 10 a.m.: Evolution of a Study of Bilateral Prefrontal Transcranial Magnetic Stimulation to Treat the Symptoms of Mild TBI and PTSD: Research Methods, Participant Demographics, and Tolerability
PTSD can be present in as many as 65% of service members who suffer a TBI1, and these co-occurring conditions can, unfortunately, confound treatment of both conditions2. The prevalence of the concurrent conditions led to a clinical trial conducted by Dr. Pasquina. During this poster session. Dr. Pasquina will present preliminary data from the double-blinded, prospective randomized, sham-controlled trial, which suggested that the treatment may be safe and tolerable among the study's military patients with diagnosed mTBI and symptoms of PTSD.
- Tuesday, August 20, 2019 at 10 a.m. — Repetitive Transcranial Magnetic Stimulation as a Protective Measure against Early-Onset Alzheimer's Disease: A Case Report
Alzheimer's Disease is a progressive neurodegenerative disease marked by a degradation of neuroplasticity and cortical breakdown. Repetitive transcranial magnetic stimulation (rTMS) is hypothesized to increase cortical plasticity and induce long-lasting changes in the cortex3,4, making it a potential therapy to slow down the development of early-onset Alzheimer's. Jared Garland will present a case report detailing the use of rTMS to delay development of early-onset Alzheimer's in a patient who had a known mutation for the disease. After completing 30 rTMS/cognitive training sessions, the patient showed high levels of tolerability and marked improvement in all cognitive domains.
Dr. Pasquina, Mr. Garland, and the Center for Rehabilitation Sciences Research at Uniformed Services University hope that their ongoing TMS technology research will improve our understanding of traumatic brain injury, post-traumatic stress and general neurophysiology. Their team remains committed to exploring improved treatment options for wounded warriors and believe that any lessons learned through these efforts will also benefit the medical research community.
As a company focused on improving quality of life for patients facing mental health challenges, Neuronetics continues to support investigator-initiated clinical trials in different areas of research and conditions to advance neurohealth. In addition to the ongoing investigator-initiated trials program, which has supported more than 50 studies in a variety of investigational areas, Neuronetics has begun clinical development on a large-scale clinical trial for PTSD. Currently, NeuroStar is FDA cleared as a safe and effective option for adult patients with Major Depressive Disorder. For more information, visit www.NeuroStar.com.
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 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, 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.
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 Taylor BC, et al. (2012) Med Care. 50(4):342-346.
2 Levin HS, et al. (2018) Oxford University Press. 2018:135.
3 Lee J, et al. (2016) J Clin Neurol. 12(1):57-64.
4 Nardone R, et al (2014) Acta Neurol Scand. 129:351-366.
5 Post A, et al. (2001) J Psychiatric Research. 35:193-215
6 Liston C, et al. (2014) Biol Psychiatry. 76(7):517-26
*Treatment time may vary depending on a doctor's recommendation.
7 Janicak PG, et al. (2008) J Clin Psychiatry
8 George MS, et al. (2010) Arch Gen Psychiatry
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