Press Releases

Soterix Medical Awarded Another Patent for High-Definition transcranial Direct Current Stimulation Platform

New York City – Apr 03, 2014

Soterix Medical Inc. announces receipt of allowance of claims from the U.S. Patent Office for an application covering their system and method of non-invasive neuromodulation using the proprietary High-Definition transcranial Direct Current Stimulation (HD-tDCS) platform. The claims cover a system and method including an array of electrodes positioned on the scalp and energized so as to achieve controlled brain current flow and targeting. The patent includes assemblies with three or more electrodes and embodiments for electrode shape, current control methods, and brain targeting. The patent recognizes the invention of HD-tDCS at The City College of New York by Dr. Marom Bikson and colleagues and is exclusively licensed to Soterix Medical Inc. that continues to innovate the platform. This invention of HD-tDCS cover any deployments of tDCS and other transcranial electrical stimulation waveforms (tES) using array of electrodes where the electrodes are positioned and energized to provide meaningful control of brain targeting.

"Since it was founded, Soterix Medical continues to be an innovation leader in non-invasive neuromodulation. Nowhere is this clear as with HD-tDCS. HD-tDCS is the only technology capable of true non-invasive neuromodulation, combining advantages of conventional transcranial Direct Current Stimulation and FDA approved transcranial Magnetic Stimulation. Scientists and clinicians already recognize Soterix Medical as the originator and leader in HD-tDCS, and this patent award further recognizes the origin of this amazing innovation.” Ongoing clinical trials with HD-tDCS span applications in Depression, Pain, Epilepsy, and Stroke Rehabilitation. Dr. Datta, CTO of Soterix Medical continues, “This patent continues to build on our success in securing intellectual property for our truly unique product and services pipeline targeted toward neurological and neuropsychiatric disorders. Our IP portfolio spans all critical aspects of non-invasive electrical stimulation with arrays, precisely because we invented and developed the devices, software, and electrodes needed to achieve required performance. Soterix Medical continues to work closely with the best clinical centers in the world in support of clinical trials with HD-tDCS."

BACKGROUND: tDCS- Limited Total Energy (tDCS-LTE) is an exclusive neuromodulation technology developed by Soterix Medical Inc. Invented at The City College of New York, tDCS-LTE is the only tDCS technology platform optimized for robust low-energy Transcranial Direct Current Stimulation. tDCS-LTE is under investigation in susceptible populations including stroke, pediatric, traumatic brain injury, etc. tDCS-LTE is made possible through a proprietary adaptive stimulation limiting the voltage and power required for tDCS. Soterix Medical tDCS-LTE is the only non-invasive neuromodulation technology further optimized for robust deployment in a wide variety of environments including emergency medicine, field-work, home-use, etc.

CAUTION: Investigational device. Federal (or United States) law limits device to investigational use.

See full press release here

Media Contact:

Robin Azzam,
Tel: +1-888-990-8327

Email: contact@soterixmedical.com

Beckman Institute Initiates Study Using Soterix Medical HD-tDCS for Fluid Intelligence: $12.7million in Funding Through IARPA

New York City – Mar 24, 2014

Soterix Medical Inc. announced today a multidisciplinary study to determine if High-Definition tDCS (HD-tDCS) in conjunction with other interventions could improve adaptive reasoning and fluid intelligence. The Beckman Institute project, named INSIGHT (“An integrative system for enhancing fluid intelligence (Gf) through human cognitive activity, fitness, high-definition transcranial direct-current brain stimulation, and nutritional intervention”) received $12.7 million in funding over 42 months from the Intelligence Advanced Research Projects Activity (IARPA), under the Office of the Director of National Intelligence. The INSIGHT project directly supports IARPA’s SHARP (Strengthening Human Adaptive Reasoning and Problem-solving) program, whose goal is to develop evidence-based tools and methods that can improve the quality of human judgment and reasoning in complex, real world environments. Headed by Aron K. Barbey, in Cognitive Neuroscience at the Beckman Institute and in the College of Applied Health Sciences, the INSIGHT clinical trial is designed to establish a comprehensive and rigorous brain training protocol that incorporates the best available cognitive, physical fitness, neuromodulation, and nutritional interventions for the enhancement of fluid intelligence. The INSIGHT trial will be one of the largest scientific studies investigating fluid intelligence conducted to date: nearly 2,000 individuals organized into four cohorts over a three-and-a-half year period, for more than 100,000 hours of planned data collection. INSIGHT program participants will engage in the training activities over 18 weeks in an effort to improve reasoning and problem solving skills. In one study arm, High-Definition tDCS will be integrated with cognitive training to investigate increased learning and performance during targeted neuromodulation. Dr. Abhishek Datta, CTO of Soterix Medical Inc. summarizes “The deployment of our HD-tDCS into potentially the largest international trial on fluid intelligence is a historical milestone in the investigation of neuromodulation to enhance human brain performance. The use of Soterix Medical HD-tDCS technology is critical to allow targeting of specific brain structures implicated in fluid intelligence with a non-invasive and well-tolerated intervention. Soterix Medical engineers and scientists continue to work closely with the Beckman Institute to facilitate safe and reliable high-throughput testing in this large clinical trial. The results of this trial may profoundly influence the development of device-based neuro-enhacement relevant to both medical and non-medical applications.” CAUTION: tDCS and HD-tDCS are limited by Federal (or United States) law to investigational use only.

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.

Complete press release here

Media Contact:

Robin Azzam,
Tel: +1-888-990-8327

Email: contact@soterixmedical.com

Soterix Medical Inc. , Rogue Resolutions Ltd., and neuroConn GmbH announce MOBILE neuromodulation platform at NYCneuromodulation 2013 conference

New York City – Dec 02, 2013

At the NYCneuromodulation 2013 conference, Soterix Medical Inc. , Rogue Resolutions Ltd, and neuroConn GmbH announced the revolutionary MOBILE neuromodulation platform. The product represents yet another collaboration between Soterix Medical Inc. (based in New York City, NY), Rogue Resolutions Ltd (based in Cardiff, UK), and neuroConn (based in Ilmenau, Germany). Leveraging over five years of engineering innovations, the MOBILE neuromodulation system is the first non-invasive brain stimulation device designed for high-throughput clinical trials and potential home use. The MOBILE stimulator is equipped with proprietary tDCS-Limited Total Energy (LTE) technology, which is the only technology optimized for low-energy neuromodulation.

Each patient receives a customized EASYstrap head-gear with an integrated MOBILE-stimulator. Compliance and safety is achieved through serial distribution of patient MOBILE-kits, each including: 1) A discharge-key that enables the MOBILE-stimulator and is programmed to provide 5 (five) timed sessions of therapy consistent with investigational treatment protocols, 2) Accessory packs including 5 (five) pairs of EASYfit or High-Definition electrodes ensuring consistent therapy thereby removing potential for patient error. Exclusive online MOBILE-smart analysis ensures proper set-up and use. Discharge-keys are cloud enabled allowing remote physician supervision.

When compliance and safety cannot be compromised, MOBILE Neuromodulation is the only system with fully integrated electrodes, head-gear, and MOBILE-smart electronics ensuring rigorous and consistent protocols. A system that is sufficiently advanced from any prior device; it could only be developed by the industry leaders in non-invasive neuromodulation. Ideal for extended trials and maintenance phases, the MOBILE device is expected to be deployed into major clinical trials throughout 2014.

Dr. Abhishek Datta, CTO of Soterix Medical summarizes “In forming this partnership with Rogue Resolutions and neuroConn, an industry leader in neuromodulation engineering, Soterix Medical reaffirms its mission to provide clinical researchers and patients with the most advanced and tested brain stimulation technology. The MOBILE system was designed to consider every eventuality in large-scale clinical trials and set-up. This is a complete system from patient set-up, to use, to cloud based compliance monitoring. The next generation EASYstrap customized to work with the MOBILE is the most robust and simple head-gear we have designed. Patients receive controlled supplies of electrodes and discharge-keys that are pre-programmed while the MOBILE stimulator includes the most intelligent monitoring systems available to ensure proper set-up. The stimulator itself has just one button. Tremendous sophistication reduced to unmatched usability. ”

BACKGROUND: tDCS- Limited Total Energy (tDCS-LTE) is an exclusive neuromodulation technology developed by Soterix Medical Inc. Invented at The City College of New York, tDCS-LTE is the only tDCS technology platform optimized for robust low-energy Transcranial Direct Current Stimulation. tDCS-LTE is under investigation in susceptible populations including stroke, pediatric, traumatic brain injury, etc. tDCS-LTE is made possible through a proprietary adaptive stimulation limiting the voltage and power required for tDCS. Soterix Medical tDCS-LTE is the only non-invasive neuromodulation technology further optimized for robust deployment in a wide variety of environments including emergency medicine, field-work, home-use, etc.

CAUTION: Investigational device. Federal (or United States) law limits device to investigational use.

See full press release here.

Media Contact:

Robin Azzam,
Tel: +1-888-990-8327

Email: contact@soterixmedical.com

Soterix Medical Inc. announces Phase 3 Clinical Trial for Depression comparing tDCS-LTE against antidepressant drug (Escitalopram)

New York City – Oct 29, 2013

NEW YORK, Oct. 29, 2013 - Soterix Medical Inc. announces today a Phase 3 trial for Major Depressive Disorder (MDD) that will compare Soterix Medical’s Transcranial Direct Current Stimulation (tDCS) -Limited Total Energy (LTE) technology against a fully dosed, effective antidepressant Escitalopram oxalate (Lexapro®). The seminal ELECT-TDCS study initiated by Dr. Andre Brunoni of the University of Sao Paulo (cinausp.org) builds on prior work published in 2013 inJAMA Psychiatry. This work combined tDCS with antidepressant sertraline and concluded “in MDD, the combination of tDCS and sertraline increases the efficacy of each treatment. The efficacy and safety of tDCS and sertraline did not differ.” The initiated Phase 3 ELECT-TDCS study, with a target enrollment of 240 patients, aims to further assess if tDCS-LTE is similarly effective to antidepressant drug medication but with far fewer side-effects. For this trial, the Soterix Medical1x1-Clinical Trials (CT) stimulator equipped with proprietary tDCS-LTE technology will provide optimized control of stimulation dose and double-blind study-control features calibrated specifically for the study. View the LTE paperhere.

Dr. Abhishek Datta, CTO of Soterix Medical summarizes “The pivotal ELECT-TDCS neuromodulation study is noteworthy for both its scale and objective to compare with an established drug medication. Most tDCS clinical trials, including theseparate ongoing multi-center trial on Depression using the Soterix Medical 1x1-CTplatform, evaluate tDCS as a stand-alone therapy. However, Soterix Medical also recognizes that tDCS may be applied in conjunction or as an alternative to drug medication. Indeed, many patients suffering from Major Depressive Disorders are insufficiently responsive to medication or suffer side-effects. The ELECT-TDCS study is designed by world leading clinical researchers to evaluate if Soterix Medical’s unique non-pharmacological treatment can be as effective as antidepressant drugs. The study will use Soterix Medical’s ground-breaking Transcranial Direct Current Stimulation Limited Total Energy (tDCS-LTE) and unique EASYstrap platform head-gear. The Soterix Medical tDCS-LTE platform is the only neuromodulation technology designed for robustness, practical scalability, and broad deployment.”

BACKGROUND:

tDCS- Limited Total Energy (tDCS-LTE)

is an exclusive neuromodulation technology developed by Soterix Medical Inc. Invented at The City College of New York, tDCS-LTE is the only tDCS technology platform optimized for robust low-energy Transcranial Direct Current Stimulation. tDCS-LTE is under investigation in susceptible populations including stroke, pediatric, traumatic brain injury, etc. tDCS-LTE is made possible through a proprietary adaptive stimulation limiting the voltage and power required for tDCS. Soterix Medical tDCS-LTE is the only non invasive neuromodulation technology further optimized for robust deployment in a wide variety of environments including emergency medicine, field-work, home-use, etc.

**Major Depressive Disorder ** or Major Depression is characterized by a combination of symptoms that interfere with a person's ability to work, sleep, study, eat, and enjoy once-pleasurable activities. Major Depression is disabling and prevents a person from functioning normally. Some people may experience only a single episode within their lifetime, but more often a person may have multiple episodes. Major Depression affects about 6.7% of the U.S. population over age 18, according to the National Institute of Mental Health. Overall, between 20% and 25% of adults may suffer an episode of Major Depression at some point during their lifetime.

See full press release here.

Media Contact:

Robin Azzam,
Tel: +1-888-990-8327

Email: contact@soterixmedical.com

Soterix Medical Awarded Patent For Optimized High-Definition transcranial Direct Current Stimulation

New York City – Aug 02, 2013

[Soterix Medical Inc.] (http://soterixmedical.com) announced they have received allowance of claims from the U.S. Patent Office for an application covering their system and method of non-invasive neuromodulation using the proprietary High-Definition transcranial Direct Current Stimulation (HD-tDCS) platform. The claims cover a system and method including a wearable apparatus to position an array of electrodes on the surface of the scalp, provide low dose stimulation to the brain using transcranial direct current stimulation (tDCS), and delivering this stimulation in manner that achieves optimal focality using a minimum number of electrodes. Focality with non-invasive electrical stimulation is considered pivotal for both efficacy and safety and is only possible with HD-tDCS. Reducing the number of electrodes adds robustness while simplifying application for the operator. HD-tDCS was developed at The City College of New York by Dr. Marom Bikson, Dr. Lucas Parra and colleagues and is exclusively licensed to Soterix Medical Inc. which continues to innovate the platform. "While Soterix Medical is broadly recognized for innovation in Neurotargeting including our HD-tDCS systems, we are also committed to maximizing dissemination and usability by ensuring we maintain the simplicity of tDCS. This is evident in features found only in Soterix Medical products including this patented invention. By using this technology operators are guaranteed maximal focality with minimal set-up. This means they can focus on the experiment and subject, and not on unneeded electrode preparation." says Abhishek Datta, CTO of Soterix Medical Inc. and co-inventor on the patent. Dr. Datta also thanked the National Institute of Health for their support of these technologies. An ongoing Phase-2 clinical trial and Harvard Medical School is evaluating the technology in patients with Fibromyalgia. Soterix Medical is committed to building its intellectual property portfolio with new applications stemming from additional on-going clinical studies. "This patent continues to build on our success in applying for and securing intellectual property for our truely innovative product and services pipeline targeted toward neuropsychiatric disorders. Strategically, it also represents a bifurcated shift in our portfolio to cover not only non-invasive brain targeting but also simplicity in application", continues Dr. Datta, "There is much more to come. Moreover, as our technology continues to be validated in clinical trials, our growing patent portfolio will ensure a strategic advantage for our company by protecting technology in our targeted markets."

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.

Media Contact
Narges Ghazi
Email: contact@soterixmedical.com

Soterix Medical, one of ten finalists for B.R.A.I.N. Prize, was announced by Israel Brain Technologies (IBT)

New York City – Jul 25, 2013

The finalists will present in front of an international judging committee at BrainTech Israel 2013 Israel’s first brain technology conference, which will take place on October 14-15, 2013 in Tel Aviv.

For IBT official announcement click here

This work recognizes innovation in neuromodulation through the Soterix Medical High-Definition tDCS platform currently in clinical trials at Harvard Medical School. Dr. Abhishek Datta summarizes "For 5 years, SMI has been the standard for innovation in neuromodulation, and this award recognizes the breakthrough of HD-tDCS, the only platform that combines the robustness and portability of tDCS with the targeting of TMS. We are thrilled for this recognition from the BRAIN prize."

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.

Media Contact
Narges Ghazi
Email: contact@soterixmedical.com

Soterix Medical Inc. reports positive results from High-Definition tDCS Fibromyalgia Trial at Harvard Medical School

New York City – Feb 20, 2013

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

Media Contact
Narges Ghazi
Email: contact@soterixmedical.com

Soterix Medical announces completion of Stroke- Aphasia Trial

New York City – Jan 15, 2013

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

Soterix Medical Inc. announces a land-mark study on generation of “peak” brain plasticity by HD-tDCS

New York City – Oct 28, 2012

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

Media Contact
Narges Ghazi
Email: contact@soterixmedical.com

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.

New York City – Oct 26, 2012

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

Media Contact
Narges Ghazi
Email: contact@soterixmedical.com

The National Institute of Health awards the Burke Medical Research Institute $3 Million to study transcranial Direct Current Stimulation (tDCS) in conjunction with robotic training in chronic stroke.

New York City – Sep 24, 2012

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 clinical trial of High-Definition transcranial Direct Current Stimulation (HD-tDCS) for pediatric epilepsy

New York City – Jun 13, 2012

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 Multi-Center transcranial Direct Current Stimulation (tDCS) Depression Trial

New York City – Jun 11, 2012

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. Announces clinical trial of High-Definition transcranial Direct Current Stimulation (HD-tDCS) for stroke aphasia

New York City – Jul 26, 2011

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

Soterix Medical Inc. Announces clinical trial of High-Definition transcranial Direct Current Stimulation (HD-tDCS) for Fibromyalgia

New York City – Jun 28, 2011

Soterix Medical Inc. announces today a new clinical trial for Chronic Pain (Fibromyalgia)

Soterix Medical Inc. announces today a Phase-1 trial for Chronic Pain and Fibromyalgia at Harvard Medical School and Spaulding Rehabilitation Hospital. The trial will be headed by Dr. Felipe Fregni, one of the foremost international neuromodulation specialists worldwide with the support of the Wallace H. Coulter Foundation and in collaboration with The City College of New York of CUNY.

Dr. Abhishek Datta, CTO of Soterix Medical states “Soterix Medical is excited that High-Definition tDCS will be evaluated for efficacy in chronic pain at the one of the best clinical trial centers for neuromodulation. There is tremendous interest in the application of neuromodulation for chronic pain disorders but only HD-tDCS allows safe and targeted delivery of DC current to targeted brain structures. As a result we expect both increased efficacy and limited side-effects. This study will use our proprietary HD-electrodes which allow safe and well tolerated stimulation.”

From ClinicalTrials.Gov “The purpose of this study is to assess the effects of high-definition transcranial direct current stimulation (HD-tDCS) on subjects with chronic musculoskeletal pain. The investigators hypothesize that subjects will show a decrease in pain symptoms in the active anodal stimulation group when compared to sham stimulation. The study will determine whether anodal or cathodal HD-tDCS is effective in reducing pain in subjects with chronic musculoskeletal pain as measured by changes in the Visual Analogue Scale (VAS) for pain. The VAS scale will be measured immediately before the HD-tDCS stimulation sessions and after the HD-tDCS stimulation sessions for each subject for the duration of their participation in the trial. This outcome will also be measured at their baseline visit, and follow-up visit.

Media Contact
Narges Ghazi
Email: contact@soterixmedical.com

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