Korea Approves NeuroStar TMS for Treating Depression
Neuronetics Partners with BR Holdings to Make Non-Invasive, Non-Drug Treatment System Available to 50 Million People
MALVERN, PA, August 14, 2013 – Neuronetics, Inc., the established market leader in Transcranial Magnetic Stimulation technology for the treatment of Major Depressive Disorder, announced today that the South Korea Ministry of Food and Drug Safety (MFDS) has approved the NeuroStar TMS Therapy® System for sale and use in the Republic of Korea.
Neuronetics will work closely with distribution partner BR Holdings, a Seoul-based leader in medical device technology, to provide sales, marketing and clinical support as medical facilities and physicians adopt NeuroStar, which is already deployed at more than 550 installations worldwide.
“The MFDS approval of NeuroStar significantly extends Neuronetics’ global leadership in addressing the need for a safe, effective, non-drug treatment for depression,” said Bruce Shook, CEO of Neuronetics, Inc. “Our distribution partnership with BR Holdings will enable us to rapidly scale up delivery of the NeuroStar TMS system into the world’s 15th largest economy, which represents a remarkable opportunity to meet the needs of millions of depression patients who need an option beyond drug therapy.”
More than 13,000 patients have been treated with NeuroStar, a non-invasive, non-drug therapeutic device that delivers highly-focused magnetic pulses to stimulate and activate neurons in localized regions of the brain. NeuroStar’s Precision Pulse TMS?? technology directly stimulates the left prefrontal cortex, a region of the brain known to be inactive in patients with depression, and also activates deep brain structures involved in mood regulation.
Depression is a serious illness that affects about 350 million people worldwide, according to the World Health Organization. People with depression may experience a range of physically and emotionally debilitating symptoms, including anxiety, sadness, irritability, fatigue, changes in sleep patterns, loss of interest in previously enjoyable activities and digestive problems.
TMS Therapy® NeuroStar TMS Therapy is indicated in Korea for the treatment of adult patients with Major Depressive Disorder (MDD) who have failed to receive satisfactory improvement from antidepressant medications. 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. NeuroStar is backed by the largest clinical evidence set in depression with six clinical studies in eight hundred patients and broad post-marketing experience. The treatment is typically administered daily for 4-6 weeks. NeuroStar TMS Therapy is available by prescription only. There is a rare risk of seizure associated with TMS (< 0.1% per acute treatment course). For full safety and prescribing information, visit www.NeuroStar.com.
About BR Holdings
BR Holdings is a leading distributor of innovative medical equipment and technology. Based in Seoul, Korea, BR Holdings takes pride in advancing human health and well-being with advanced medical device solutions. Backed by a team of dedicated sales, technical and customer support staff, BR Holdings is committed to the delivery of quality products and services to all customers, driven by continual improvement to meet total customer satisfaction. For more information, please visit www.br-holdings.com.
Neuronetics, Inc. is a privately-held medical device company focused on developing noninvasive 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. Neuronetics was created as a spin-out of The Innovation Factory, a medical device incubator in Duluth, GA. For more information, please visit www.neuronetics.com.
NeuroStar®, NeuroStar TMS Therapy® and TMS Therapy® are registered trademarks of Neuronetics, Inc.