MALVERN, Pa., May 17 Neuronetics, Inc. announced today that in addition to independent research by the National Institute of Mental Health (NIMH), new data exploring the clinical utility of Transcranial Magnetic Stimulation (TMS) Therapy in depression will be presented at the upcoming American Psychiatric Association's annual meeting in New Orleans. NeuroStar TMS Therapy® is the fastest growing non-pharmaceutical treatment for depression in the U.S.(i)
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"It's truly an exciting time for Neuronetics with overwhelming interest in TMS Therapy from psychiatric researchers, clinicians and patients," said Neuronetics' President and CEO, Bruce Shook. "The NIMH study provides very important and independent validation of previous research and confirms the value of NeuroStar TMS Therapy as an effective and safe therapy for patients suffering from major depression who have not done well on drug therapy."(ii)
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Initial findings from the NIMH, sham-controlled, randomized study, published in this month's Archives of General Psychiatry, concluded that TMS was "a monotherapy with few adverse effects and significant antidepressant effects for unipolar depressed patients who do not respond to medications or who cannot tolerate them."(ii) While the study was conducted independently, Neuronetics supplied its NeuroStar TMS Therapy systems for the study.(ii) Neuronetics is the only manufacturer of a TMS device that has been FDA-cleared for the treatment of depression.
"Having patients reach remission should be the goal for every physician," said Mark Demitrack, M.D., Chief Medical Officer of Neuronetics. "We are encouraged to see that the odds of patients achieving remission with TMS were four times greater when compared to the sham group.(ii) This data confirms and replicates our prior clinical trial data for NeuroStar TMS Therapy and we look forward to further exploring additional benefits of TMS Therapy for patients."
In addition to the NIMH study, several other APA sessions and research will evaluate TMS Therapy.
About NeuroStar TMS Therapy
NeuroStar TMS Therapy was cleared by the FDA in October 2008 for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from one prior antidepressant medication at or above the minimal effective dose and duration in the current episode. NeuroStar TMS Therapy is a non-systemic (does not circulate in the bloodstream throughout the body) and non-invasive (does not involve surgery) form of neuromodulation.
TMS Therapy uses highly focused, pulsed magnetic fields to restore function in brain regions believed to be linked to depression. It is an outpatient procedure performed in a physician's office daily for 4-6 weeks. There are no systemic side effects such as sedation, cognitive-blunting, weight gain, sexual dysfunction, or nausea.(iii) The most common adverse events related to TMS treatment are scalp pain or discomfort at the treatment area. NeuroStar TMS Therapy is contraindicated in patients with implanted metallic devices on non-removable metallic objects in or around the head. NeuroStar TMS Therapy is available only upon the prescription of a psychiatrist.
In clinical trials, patients treated with active NeuroStar TMS Therapy experienced an average reduction in their depression symptom score of 22.1% compared to a 9% reduction in patients receiving inactive treatment(i). In a Neuronetics-sponsored, open-label clinical trial, which is most like real world clinical practice, approximately 1 in 2 patients experienced significant improvement in symptoms, and 1 in 3 experienced complete symptom resolution. NeuroStar TMS Therapy has not been studied in patients who have not received prior antidepressant treatment; efficacy has not been established in patients who failed to benefit from 2 or more antidepressant medications at minimal effective dose and duration in the current episode.(iv)
Availability of NeuroStar TMS Therapy
Treatment with NeuroStar TMS Therapy is now available at over 190 treatment centers in the U.S., in both physician offices and select hospitals, including seven of the top 10 psychiatric hospitals identified by U.S. News and World Report. For specific information on treatment locations with NeuroStar TMS Therapy, please visit www.NeuroStarTMS.com or call the Neuronetics Customer Service Center at (877) 600-7555.
About Neuronetics
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 is the leader in the development of TMS Therapy. For more information, please visit www.neuronetics.com.
NeuroStar®, NeuroStar TMS Therapy®, and TMS Therapy® are registered trademarks of Neuronetics, Inc.
(i) Neuronetics data on file.
(ii) George et al. Arch Gen Psychiatry. 2010;67[5]:507-516.
(iii) Janicak PG et al. J Clin Psychiatry. 2008;69(2):222-232.
(iv) Demitrack, MA, Thase, M. Psychopharmacology Bulletin 2009; 42(2), 5-38.
TMS Therapy Presentations at APA Date: Monday, May 24, 2010 Time: 2:00 - 5:00 PM Symposium Title: Focal Brain Stimulation for Psychiatric Disorders: Clinical Update Presentation The Clinical Safety and Efficacy of Transcranial Title: Magnetic Stimulation: Results from Recent Pivotal Clinical Trials Presenter: William M. McDonald, M.D. Time: 3:00 - 5:00 Session Title: New Research Poster Session 3 Presentation Methodologic Approaches in the Naturalistic Title: Assessment of Clinical Utilization and Outcome of a Device-Based Treatment in Clinical Practice Poster: NR3-67 Presenter: Mark Demitrack, M.D.
SOURCE Neuronetics, Inc.
