Soterix Medical Announces Completion of Stroke-Aphasia Trial
Jan 15, 2013, 08:07 ET
NEW YORK, Jan. 15, 2013 /PRNewswire/ -- Soterix Medical,Inc. a New York-based medical device company announced today the completion of its Phase-1 Stroke-Aphasia trial using its revolutionary and proprietary non-invasive brain targeting platform called High Definition-Transcranial Direct Current Stimulation (HD-tDCS) 1.
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Stroke is the fourth leading cause of death in the U.S. affecting 800,000 every year.
"We are proud to complete our Phase-1 trial. This is a major milestone for Soterix Medical and enhances our efforts to transform the way Stroke rehabilitation is managed. I wish to thank National Institute of Health for funding this study, the partnering clinical site of University of South Carolina and recognize each and every patient in our clinical trial," said Dr. Abhishek Datta, Chief Technology Officer, Co-Founder of Soterix Medical, and Co-Inventor of HD-tDCS. "We are thrilled to see the fruition of our vision of using small electrode arrays to deliver targeted stimulation to desired brain targets. Our patented approach allows individualized tDCS therapy and initial studies indicate more tolerable stimulation than conventional-tDCS using sponges."
Soterix Medical has secured FDA-Investigational Device Exemption (IDE) in anticipation of a muti-site Phase-2 trial.
In a recent landmark study from the group that introduced tDCS in its current form, Dr. Michael Nitsche and Dr. Walter Paulus found that HD-tDCS produced larger and longer-lasting brain excitability changes than conventional-tDCS 2.
Background:HD-tDCS platform
HD-tDCS was invented after years of compelling modeling evidence and comprehensive animal/ pre-clinical studies conducted at City University of New York (CUNY). Dr. Abhishek Datta spearheaded the modeling approach as part of his doctoral study at the CUNY laboratory of Dr. Marom Bikson and Dr. Lucas C. Parra. HD-tDCS was developed to combine the benefits of tDCS, namely low-intensity currents, safety profile, and neuromodulation plasticity with targeting control matching Transcranial Magnetic Stimulation - an FDA approved therapy. The HD-tDCS platform comprises either the basic 4-channel Adapter (4x1) or the advanced 8-channel Stimulator (MxN). HD-tDCS dose (electrode placement and individual electrode currents) is determined using individualized brain current-flow modeling in combination with the Neurotargeting Softwares: HDTargets and HDExplore.
CAUTION: tDCS and HD-tDCS are limited by Federal (or United States) law to investigational use only.
HD-tDCS, 1x1, 4x1, MxN, HDTargets, HDExplore are trademarks of Soterix Medical, Inc.
About Soterix Medical, Inc.
Soterix Medical is a New York-based medical device company established to develop electrotherapies that allow painless and non-invasive targeting of brain and spinal-cord structures. Soterix Medical provides the following therapy platforms: Transcranial Direct Current Stimulation (tDCS), Transcutaneous Spinal Direct Current Stimulation (tSDCS) and High Definition-Transcranial Direct Current Stimulation (HD-tDCS). Soterix Medical has secured the multi-faceted HD-tDCS intellectual property licensed on an exclusive basis from CUNY. Clinical trials are currently on-going for Stroke Rehabilitation, Depression, Pain, Epilepsy, Down Syndrome, etc. Soterix Medical is the exclusive manufacturer and provider of HD-tDCS.
1 Research reported in this publication was supported by the National Institute Of Neurological Disorders And Stroke of the National Institutes of Health under Award Number R41NS076123. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
2 http://www.brainstimjrnl.com/article/S1935-861X%2812%2900183-0/abstract
SOURCE Soterix Medical, Inc.