New Treatment for Depression Recognized in Life Sciences Category MALVERN, Penn. - May 9, 2011 - Neuronetics, Inc., maker of the NeuroStar Transcranial Magnetic Stimulation (TMS) Therapy® System, has been selected by TiE Silicon Valley as a 2011 recipient of the TiE 50 Award. Neuronetics' NeuroStar TMS Therapy System is the first and only non-systemic and non-invasive TMS device cleared by the U.S. Food and Drug Administration (FDA) for the treatment of major depressive disorder (MDD).* More than 1,600 technology startups worldwide are screened for the 50 awards in five categories of the TiE50, TiE's premier annual awards program. Awards are presented at TiEcon, the world's largest entrepreneur's conference. An awards ceremony will take place on May 13 in Santa Clara, Calif. "It is a great honor to be a 2011 TiE50 Award winner," said Neuronetics' President and CEO, Bruce Shook. "Everyone at Neuronetics has worked incredibly hard to make our NeuroStar® TMS system widely available to people suffering from depression. Thousands have benefited from the entrepreneurial spirit and focused effort that made NeuroStar TMS Therapy a reality. It is a privilege to have our hard work recognized by TiE." TiE is a global, not-for-profit network dedicated to the advancement of entrepreneurship. It provides a platform for mentoring, networking and education to entrepreneurs with more than 13,000 members in 56 chapters across 13 countries. 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. It stimulates nerve cells in an area of the brain that has been linked to depression, by delivering highly focused MRI-strength magnetic field pulses. The treatment is typically administered daily for four to six weeks. In clinical trials, patients treated with active NeuroStar TMS Therapy experienced an average reduction in their depression symptom score of 22.1 percent compared to a 9 percent reduction in patients receiving inactive treatment.[1] In an open-label clinical trial, which is most like real world clinical practice, approximately one in two patients experienced significant improvement in symptoms, and one in three experienced complete symptom resolution.[2] There were no systemic side effects such as those experienced with some antidepressant medications. The most common adverse events related to treatment were scalp pain or discomfort at the treatment area during active treatments.[3] There is a rare risk of seizure with TMS Therapy (0.1 percent of patients under general clinical use). NeuroStar TMS Therapy is contraindicated in patients with non-removable metallic objects in or around the head. NeuroStar TMS Therapy is not indicated or effective for all patients with depression; it is available only upon the prescription of a psychiatrist. For full safety and prescribing information, visit www.NeuroStarTMS.com. Availability of NeuroStar TMS Therapy Treatment with NeuroStar TMS Therapy is available at more than 300 treatment centers throughout the United States. For information on specific treatment locations that offer NeuroStar TMS Therapy, please visit www.NeuroStar.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, a non-invasive form of neuromodulation. For more information, please visit www.neuronetics.com. About Depression Depression affects at least 14 million American adults each year. Of those suffering from depression, 6.8 million do not even seek treatment. [4]Often a debilitating disorder, depression results in a persistent state of sadness that interferes with an individual's thoughts, behavior, mood, and physical health. It is important to recognize the symptoms and seek treatment as soon as possible.
NeuroStar®, NeuroStar TMS Therapy®, and TMS Therapy® are registered trademarks of Neuronetics, Inc. ###
[1] Data on file, Neuronetics, Inc. [2] Demitrack, M. A. and M. Thase (2009). "Clinical Significance of Transcranial Magnetic Stimulation (TMS) in the Treatment of Pharmacoresistant Depression: Synthesis of Recent Data."Psychopharmacology Bulletin 42(2): 5 - 38.
[3] Janicak, P., J. P. O'Reardon, et al. (2008). "Transcranial Magnetic Stimulation in the Treatment of Major Depressive Disorder: A Comprehensive Summary of Safety Experience from Acute Exposure, Extended Exposure, and During Reintroduction Treatment." Journal of Clinical Psychiatry 69(2): 222 - 232.
[4] Kessler, R., P. Berglund, et al. (2003). "The Epidemiology of Major Depressive Disorder: Results from the National Comorbidity Survey Replication (NCS-R)." (JAMA) Journal of the American Medical Association 289(23): 3095-3105.
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Thursday, May 26, 2011
Neuronetics Receives TiE50 Award for Technology Entrepreneurship
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