NEW YORK, Feb. 20, 2013- Soterix Medical Inc. is pleased to report positive results of a double-blind, sham-controlled, crossover trial of 18 patients with Fibromyalgia conducted at Harvard Medical School. Fibromyalgia is a prevalent chronic pain syndrome characterized by altered pain and sensory processing in the central nervous system, which is often refractory to multiple therapeutic approaches. The Harvard clinical trial examined the effects of the Soterix Medical’s exclusive 4x1 High Definition - Transcranial Direct Current Stimulation (HD-tDCS) on overall perceived pain in patients. HD-tDCS proved well tolerated and produced a significant reduction in overall perceived pain in Fibromyalgia patients as compared to sham stimulation. View the paper here

“We are thrilled at these positive results in Fibromyalgia,” said Dr. Abhishek Datta, CTO of Soterix Medical, “Patients with Fibromyalgia are often refractory to pharmacological intervention and experience side-effects, so the ability of just one session of HD-tDCS to reduce pain without side-effects is striking. The effects observed in a single session were larger than with either conventional tDCS or FDA approved Transcranial Magnetic Stimulation (TMS). We expect that with repeated HD-tDCS, both the magnitude and durability of effects will increase and this is precisely the objective of our enhanced HD-tDCS Fibromyalgia multi-center trial – which is now recruiting, including at Harvard Medical School. These results are only possible with the proprietary Soterix Medical HD-tDCS where unique electrode and specialized arrays provide non-invasive targeted Neuromodulation not possible with any other technique. Soterix Medical will continue to pioneer HD-tDCS and its investigation in Fibromyalgia and other pain syndromes.”

These results follow mechanistic findings at University of Michigan - tDCS using the Soterix Medical 1x1 promotes release of endogenous opioids providing a mechanistic substrate for the treatment of pain disorders and Migraine. View the paper here

BACKGROUND: High-Definition tDCS (HD-tDCS) is an exclusive Neuromodulation technology developed by Soterix Medical Inc. Invented at The City College of New York, it is the only technology platform that allows tolerated non-invasive delivery of therapeutic current to desired brain regions. As a result, HD-tDCS offers potential for safe and effective treatment of neuropsychiatric disorders not possible with any other technology. HD-tDCS is made possible through innovations in electrode design allowing safe and tolerated passage of current through proprietary “High-Definition” electrodes, individualized brain current-flow modeling and through patented targeting algorithms indicating how to place and energize HD-electrodes on the head.

Fibromyalgia (FM or FMS) is a medical disorder characterized by chronic widespread pain and allodynia (a heightened and painful response to pressure). Fibromyalgia is one of the most common chronic pain conditions. The disorder affects an estimated 10 million people in the U.S. and an estimated 3-6% of the world population. It is most prevalent in women —75-90% of people who have FM are women. Fibromyalgia symptoms are not restricted to pain, leading to the use of the alternative term Fibromyalgia Syndrome for the condition. Other symptoms include debilitating fatigue, sleep disturbance, and joint stiffness. Some patients also report cognitive dysfunction.

See full press release here

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Narges Ghazi
Email: contact@soterixmedical.com

Soterix Medical,Inc. 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.

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.

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.

HD-tDCS,1x1,4x1,MxN, HDTargets, HDExplore are trademarks of Soterix Medical Inc

See full press release here

Media Contact
Narges Ghazi
Email: contact@soterixmedical.com

In 2000, Dr. Michael Nitsche and Dr. Walter Paulus launched conventional transcranial Direct Current Stimulation by showing lasting changes in brain plasticity. To date, over 100 clinical trials have investigated the ‘plasticity-boosting’ effects tDCS for the treatment of neuro-psychiatric diseases and as an adjunct to rehabilitation. Soterix Medical announces the completion of trial by Dr. Nitsche and Dr. Paulus comparing plasticity produced by conventional tDCS and High-Definition tDCS. Results show that HD-tDCS produces larger excitability and longer lasting changes. 10 minutes of HD-tDCS produced over 2 hours of lasting plasticity changes, with less average skin sensation than conventional tDCS, and no significant side-effects.View the paper here

“We could not be more pleased with these results. High-Definition tDCS combines the true neuromodulation of tDCS with the focality of TMS” Dr. Abishek Datta, CTO of Soterix Medical Inc. explains. "With this land-mark study by the leaders in low-intensity neuromodulation, we now know that HD-tDCS can produce longer lasting plasticity changes than tDCS or TMS. The implications of ‘peak’ neuroplasticity in clinical treatment, where long lasting changes are critical are clear.”

For more on Soterix Medical HD-tDCS

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Narges Ghazi
Email: contact@soterixmedical.com

Aug 27, 2012 Soterix Medical Inc. receives FDA IDE for Clinical Trial on Use of High-Definition transcranial Direct Current Stimulation (HD-tDCS) to improve IQ in pediatric Down syndrome. This small pilot study of Soterix Medical Inc. exclusive High-Definition tDCS technology will be lead by investigators at University of Wisconsin-Madison under IRB approval. High-Definition tDCS is the only non-invasive, brain targeted, and low-intensity technology designed to promote neuroplasticity.

More about pediatric Down syndrome at NIH

For more on Soterix Medical HD-tDCS

More about Soterix Medical Inc. Limited Total Energy for Susceptible Populations

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Narges Ghazi
Email: contact@soterixmedical.com

From the NIH website: ”Stroke survivors are often left with residual motor dysfunction, which despite the best-known care,results in substantial personal, social and economic cost.We suggest that Transcranial Direct Current Stimulation (tDCS) delivered prior to robotic motor training will improve clinical function when performed over 12 weeks of training. We propose to test cortical neurophysiology and kinematic changes in relation to improved clinical function to report the specific aspects of movement control that are enhanced, and the underlying brain plasticity. This will help understand the physiological and behavioral aspects of this emerging rehabilitation strategy, and may be useful to guide clinical trials for optimizing motor recovery in stroke, and ultimately to have broader application to other neurological disorders.”

More details at NIH

Abhishek Datta, CTO of Soterix Medical summarizes “The Soterix Medical 1x1 tDCS device and accessories are the most advanced and controlled platform for direct current delivered as an adjunct to rehabilitation. Soterix Medical has established relationship with international leading centers such as Burke Medical Research Institute and Burke Rehabilitation Hospital where Prof. Dylan Edwards is leading the most systematic analysis of tDCS for this indication to date. For large studies requiring consistent preparation, the Soterix EASYpads provide un-paralleled reproducibility, while the set-up and fit of the EASYpads allow simple and reliable fixation of the EASYpads to the scalp. ”

For more on Soterix 1x1 Stimulators see Soterix Medical 1x1 tDCS

More on the Non-Invasive Brain Stimulation and Human Motor Control Laboratory at The Burke Medical Research Institute

Media Contact
Narges Ghazi
Email: contact@soterixmedical.com

Soterix Medical Inc. announces today a new clinical trial for Pediatric Epilepsy supported by the Epilepsy Foundation.

Epilepsy Foundation awards a New Therapy Grant for a clinical trial of High-Definition tDCS in pediatric epilepsy. Dr. Alexander Rotenberg will lead a team of clinical investigators including at Children’s Hospital, Boston and Harvard Medical School. The study will use High-Definition (HD) tDCS to deliver focal inhibitory current and Soterix Medical Custom Solution modeling to optimize targeting.

On June 21, 2012, The Epilepsy Therapy Project (ETP) and the Epilepsy Foundation (EF) announced that Soterix Medical received the New Therapy Grants Program, a unique joint venture of these two non-profit epilepsy organizations to advance clinical development and commercialization of promising epilepsy therapies."The mission of this collaborative grant program is to improve the quality of life for people living with epilepsy in their lifetimes," said Sandy Finucane, Executive Vice President of the Epilepsy Foundation."Epilepsy affects nearly three million people in the United States and 65 million people worldwide. Even with current treatments, close to one third of people with epilepsy live with uncontrolled seizures and there remains an overwhelming need for new treatment options."

Dr. Abhishek Datta, CTO of Soterix Medical summarizes “The Soterix Medical High-Definition tDCS system is the only technology capable of delivering uni-directional hyper-polarizing only targeted stimulation to the brain. This combination of features made HD-tDCS the optimal choice for this trial. In addition, our software systems allow patient specific design of stimulation protocol to account for both individual anatomical differences and seizure focus.” About the Epilepsy Foundation

The Epilepsy Foundation, a national nonprofit with affiliated organizations throughout the United States, has led the fight against epilepsy since 1968. The Foundation's mission is to stop seizures, find cures and overcome the challenges created by epilepsy. For additional information, please visitwww.epilepsyfoundation.org.

About the Epilepsy Therapy Project

The Epilepsy Therapy Project is a 501(c) (3) non-profit organization whose mission is to accelerate ideas into therapies for people living with epilepsy and seizures. Founded in 2002 by a group of parents, distinguished physicians, and researchers, the Epilepsy Therapy Project supports the commercialization of new therapies through direct grants and investments in promising academic and commercial projects. For more information about epilepsy, epilepsy treatment and the epilepsy pipeline, please visit our website, www.epilepsy.com or call 540.687.8077

Media Contact
Narges Ghazi
Email: contact@soterixmedical.com

Soterix Medical Inc. announces today a multi-center trial for Depression. The largest multi-center tDCS trial to date is investigator initiated by Dr. Colleen Loo at the Black Dog Institute at The University of South Wales with additional sites including Duke University, Emory University, Sheppard Pratt Health System, University of Medicine and Dentistry New Jersey, and the University of Texas. This study build on prior work suggesting tDCS has antidepressant efficacy in a 3 week double-blind,randomized,sham-controlled trial.

Dr. Abhishek Datta, CTO of Soterix Medical summarizes “This study will be the largest and most rigorous clinical trial of tDCS to-date. For this trial, the Soterix Medical 1x1 CT will provide optimized control of stimulation dose with additional double-blind and study-control features unique to the CT. The study will include Soterix Medical Limited Total Energy (LTE) intelligent ramp technology and leverage the easy to use EASYStrap platform.”

From the Black Dog Institute: “New Trial of Non-Medication Treatment for Depression – Direct Current Stimulation. Researchers are investigating direct current stimulation (DCS) as a treatment for depression and potential alternative to medication and electroconvulsive therapy. The stimulation is painless with no known serious side effects (some people report a headache afterwards), and the person is fully awake and alert during the 30 minute treatment sessions.”

From ClinicalTrials.Gov “Transcranial direct current stimulation (tDCS) is a novel treatment approach for depression that has shown promising efficacy in four recent double-blind, randomized, sham-controlled trials (RCT) and a meta-analysis. This study is a RCT of tDCS in depressed patients, testing its efficacy in both unipolar and bipolar depression. Mood, cognitive test performance and biomarkers will be measured during the trial.”

Media Contact
Narges Ghazi
Email: contact@soterixmedical.com

Soterix Medical Inc. has been awarded a Phase I NIH-STTR grant from the National Institute of Neurological Disorders and Stroke (NINDS) for the development of its High-Definition tDCS platform for the treatment of stroke aphasia. City University of New York is the partnering research institution. Clinical trials will be run at University of South Carolina.

Soterix Medical’s Phase I grant of approximately $540,000 extends over a period of more than a year. The NINDS STTR program may provide up to an additional $3 million of follow-on Phase II funding for additional clinical studies. The focus of the project is to design, prototype, and validate the first individualized electro-therapy system for stroke rehabilitation. Patient-specific dose accounting for stroke anatomy will be delivered to target the peri-lesional areas to improve stroke rehabilitation. The stimulation device and protocols developed in this project are further applicable to motor rehabilitation in stroke and other promising areas of targeted electro-therapy.

“We are extremely pleased to have received this funding from NIH-NINDS. This is an important first step in developing and commercializing our High-Definition tDCS platform” said Abhishek Datta, Ph.D., who is the company PI on the award. Dr. Julius Fridriksson, Ph.D. an internationally renowned stroke-aphasia researcher is the Co-Investigator. He will spearhead the clinical trial, which will be performed by his team at University of South Carolina.

Media Contact
Narges Ghazi
Email: contact@soterixmedical.com