Press Releases

Soterix Medical Inc. awarded $2.5M NIH grant to run Phase-2 Efficacy Trial to treat Aphasia after Stroke with HD-tDCS

New York City – Jun 15, 2016

Soterix Medical, Inc. (SMI), the leading non-invasive neuromodulation medical technology company, announces the award of a $2.5 million grant from the National Institute of Neurological Disorders and Stroke to support a Phase-2 Clinical Trial aimed at establishing the effectiveness of individualized High-Definition transcranial Direct Current Stimulation (HD-tDCS™) for adjunctive treatment of anomia in chronic post-stroke aphasia. The multi-center, randomized, sham-controlled, double-blind trial includes collaborators from Georgetown University, University of North Carolina, Medstar Research Institute, The City College of New York (CCNY) and University of South Carolina.
Additional trial information can be found here.

Aphasia is an impairment of language, affecting production or comprehension of speech and the ability to read or write. It is a debilitating long-term consequence for 1 in 5 stroke cases. For these patients, HD-tDCS, combined with speech therapy, has the potential to improve language function. HD-tDCS delivers current to an individually targeted brain region to enhance plasticity during speech therapy and thus improve functional outcomes. Individualized targeting is particularly important in stroke rehabilitation where the presence of brain lesions leads to drastically altered stimulation pattern. Based on each patient brain scan (MRI), therapy can be targeted by clinicians to specific viable brain areas determined with functional MRI, making HD-tDCS, the first non-invasive individualized neuromodulation technique.

The Phase-2 Clinical Trial follows a successful Phase-1 Clinical Trial that demonstrated that Soterix Medical’s exclusive Neurotargeting™ software could be used to individualize therapy to each patient, with the goal to boost plasticity in the targeted brain regions. The hardware system uses patent protected "HD" electrode arrays.
Dr. Abhishek Datta, Scientist and CTO of SMI and Dr. Lucas C. Parra, Professor of Biomedical Engineering at CCNY will lead the study as Principal Investigators.

"This grant from the National Institute of Health will advance the validation of HD- tDCS as the only neuromodulation platform that is non-invasive, low-intensity, and targeted. Soterix Medical is the technology leader in non-invasive neuromodulation with a commitment to enhance the treatment of neuropsychiatric disorders and neuro-rehabilitation after injury. This trial supports our mission to translate medical research in neuromodulation to clinical practice." said Dr. Datta. "I am very pleased that NIH has funded this extremely important Phase-2 trial. The full development of this electrical stimulation platform and the safety outcomes have potentially broader clinical applicability included motor recovery in stroke and analgesic effects in central pain" said Dr. Parra.

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

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.

See full press release here

Contact
Soterix Medical
Kamran Nazim,
+1-888-990-8327
Email: contact@soterixmedical.com

Soterix Medical, Inc. Announces tDCS-LTE Depression Treatment Partnership Program for Clinicians and Medical Centers based on its Non-invasive Neuromodulation Platform

New York City – May 17, 2016

Soterix Medical, Inc. announced today that it is seeking physicians and clinical centers across the European Union (EU) to join its tDCS-LTE™ Depression Treatment partnership program. This announcement follows the receipt of CE Mark approval for its tDCS-LTE™ Therapy System for the treatment of Major Depressive Disorder (MDD). As part of this program, Soterix Medical will directly work with medical administrators and physicians in helping them incorporate tDCS-LTE™ into their practice. Soterix Medical will provide specialized education, training, and treatment guidance based on validation of its technology at leading centers worldwide. Structured around regional hubs, the program will also provide physicians access to a patient referral program connecting patients to local physicians. Interested groups in the EU can contact the Soterix Medical immediately at contact@soterixmedical.com.

"The Depression Treatment partnership program will expedite and simplify incorporating our technology into clinical practice,” said Shani San Solo, VP Europe Business, Soterix Medical, “The tDCS-LTE™ Therapy System for Depression is the only transcranial Direct Current Stimulation (tDCS) technology designed for routine clinical use, including clinical-grade hardware, software, and accessories. We intend to directly educate physicians so that they get access to quality technology and are able to re-create successful treatment protocols”.

Dr. Abhishek Datta, Soterix Medical Scientist and CTO explains, “This program continues to be part of Soterix Medical’s mission to provide relief to patients worldwide. The program bridges the gap between tDCS experience at academic research studies and its application in medical practice. Our support of the most comprehensive tDCS clinical trials, allows us to immediately facilitate controlled transition to the practitioners’ offices. Ultimately, clinicians choose Soterix Medical systems for the same reason as academic researchers: because patient safety and treatment efficacy cannot be compromised.”

Soterix Medical’s Partnership program includes support on the entire patient treatment pipeline, hands-on training and staff certification, and connection to our network of physician researchers. Guidance on integrating tDCS with other treatments such as rTMS and ECT is available.

CAUTION: Investigational device. Federal (or United States) law limits device to investigational use.
See full press release here

Contact
Soterix Medical
Kamran Nazim,
+1-888-990-8327
Email: contact@soterixmedical.com

Soterix Medical Launches PainX tDCS Treatment in EU with CE Approval

New York City – Jan 14, 2016

Soterix Medical, Inc. announced the PainX™ treatment platform for Fibromyalgia and Migraine based on its proprietary transcranial Direct Current Stimulation (tDCS) technology. This announcement coincides with the receipt of CE Mark approval for the treatment of pain disorders. PainX™ tDCS treatment is available immediately in the EU.

Soterix Medical PainX™ tDCS Therapy is a non-invasive, non-systemic device that delivers low-intensity direct current to a region of the cerebral cortex to either control perception of pain or modulate reaction to painful experiences. PainX™ tDCS is a highly-promising therapy for adults living with chronic pain without the systemic side effects commonly associated with oral pain medications. Moreover, it may present a valuable option for patients unresponsive to conventional treatment. The PainX™ therapy is the first tDCS system to incorporate control and safety features suitable for clinical deployment in the treatment of pain. PainX™ hardware is a battery-powered device that connects to a headgear that painlessly guides current to targeted brain regions during a short outpatient treatment session.

"We are glad Soterix Medical can bring light into the lives of patients suffering form chronic pain disorders," said Shani San Solo, VP Europe Business for Soterix Medical. "The CE approval allows our unique tDCS technology to provide an effective, safe and well-tolerated solution for the severe conditions like fibromyalgia, migraine, and other forms of chronic pain. This approval, coming soon after the CE approval of Soterix Medical 1x1 tDCS for Depression, reinforces the standing of Soterix Medical as the leader in non-invasive neuromodulation."

Dr. Abhishek Datta, CTO of Soterix Medical explains, "Many chronic pain disorders are associated with neuropathic pain, meaning pain that originates through maladaptive plasticity in the brain. The PainX™ tDCS therapy enhances adaptive plasticity encouraging correction of brain activity. Critical to the validation of a safe and effective treatment for pain, was over 5 years of design and testing of the PainX™ stimulator and headgear."

The CE mark decision is based on 14 positive studies spanning 8 years for conditions such as fibromyalgia, migraine, spinal cord injury, etc. In most cases, patients could experience rapid benefit. Some studies showed sustained benefit ranging from 3 to 12 weeks post-stimulation. The most common side effects were limited to itching and tingling with rare instances of headache.

CAUTION: tDCS is limited by Federal (or United States) law to investigational use only

About Soterix Medical PainX™ Therapy

Soterix Medical PainX™ 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 modulates nerve cells in an area of the brain that has been linked to pain by delivering low-intensity current fields. The treatment is typically administered daily for 3 weeks with additional continuation sessions administered weekly for a total of around 20 sessions. Soterix Medical PainX™ is available by prescription only in approved markets. Typical side effects are mild including itching and skin redness that resolve shortly after treatment.

Contact
Kamran Nazim,
+1-888-990-8327
Email: contact@soterixmedical.com

Soterix Medical, Inc. Receives CE Mark Approval for 1x1 tDCS Depression Therapy

New York City – Dec 29, 2015

Non-Invasive, Non-Drug Solution Offers Hope to Millions of Adults Living with Major Depression

Soterix Medical, Inc. announced today the receipt of CE Mark approval for its 1x1 tDCS™ Therapy System for the treatment of Major Depressive Disorder (MDD). The decision is based on data from four studies, collectively that demonstrate the safety and efficacy of 1x1 tDCS Therapy in depressed patients across a broad range of antidepressant treatment resistance. Two of the studies showed sustained benefit through one month of follow-up in a majority of patients, with only twelve percent of patients experiencing a relapse of illness. One study which tested continuation tDCS in a prolonged 6 month follow-up phase noted mean response duration of 11.7 weeks.

"There is a significant need to extend non-drug treatment options to patients with depression, as not all patients respond to drug therapy,” said Shani San Solo, VP Europe Business for Soterix Medical, Inc. “The CE Mark for 1x1 tDCS Therapy System is an important milestone as it signifies that we have met the requirements of the European Union (EU) authorities with extensive clinical efficacy and safety evidence to support the role of 1x1 tDCS in treating depression. This announcement also allows commercialization of the 1x1 tDCS System in countries in Asia and Latin America that recognize the CE Mark"

Soterix Medical 1x1 tDCS Therapy is a non-invasive, non-systemic therapeutic device that delivers low-intensity direct current to a region of the cerebral cortex, the part of the brain that controls mood. 1x1 tDCS is a highly-promising therapy for adults living with MDD without the systemic side effects commonly associated with oral antidepressant medications.

Dr. Abhishek Datta, Soterix Medical CTO explains, “The 1x1 tDCS Therapy system is the first device for transcranial Direct Current Stimulation that provides clinical grade quality, controls, and features. The CE Mark approval for the 1x1 tDCS certifies that the 1x1 tDCS Therapy system can be used immediately for many adults in EU with depression supporting Soterix Medical’s mission to provide relief to patients around the world.”

CAUTION: tDCS is limited by Federal (or United States) law to investigational use only.

About Soterix Medical 1x1 tDCS Therapy
1x1 tDCS 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 modulates nerve cells in an area of the brain that has been linked to depression by delivering low-intensity current fields. The treatment is typically administered daily for 3 weeks with additional continuation sessions administered weekly for a total of around 20 sessions. 1x1 tDCS is available by prescription only in approved markets. Typical side effects are mild including itching and skin redness that resolve shortly after treatment. For more information, visit SoterixMedical.com.

See full press release here

CONTACTS:
Kamran Nazim,
Tel: +1-888-990-8327
Email: Contact@soterixmedical.com

Soterix Medical Inc. Agreement with Caputron Medical LLC

New York City – Jul 30, 2015

Soterix Medical Inc. announces today a distribution agreement with Caputron Medical LLC, an emerging neuromodulation and neurodiagnostic medical technology company which brings Caputron Medical the rights to market Soterix Medical’s industry leading transcranial Direct Current Stimulation (tDCS) and exclusive High-Definition tDCS (HD-tDCS) products for investigational use. As part of the agreement, Caputron Medical is provided access to Soterix Medical’s ISO-certified, FDA QS compliant medical device design and fabrication facility in New York City for the purposes of product validation and shipping receivables for the distribution agreement. As part of the agreement, Soterix Medical is provided access to Caputron Medical’s storage and shipment facilities in New York City and in Newark, New Jersey, and online and international sales channels, for the duration for the distribution agreement. The agreement initiates a partnership between two of New York’s fastest growing medical devices companies.

Robin Azzam, CEO of Caputron Medical commented: “The addition of the Soterix Medical technologies to our growing product portfolio demonstrates Caputron Medical’s commitment to providing our customers with the best neuromodulation technology with the goals of understanding neurological conditions and the improvement of patient treatment. Soterix Medical tDCS and HD-tDCS products will complement our other neuromodulation and neuromonitoring technologies and indeed Soterix Medical “plus monitoring” program is state-of-the-art in technology integration.”

Dr. Abhishek Datta, CTO of Soterix Medical, added: “Caputron Medical is unique in the breadth of device and accessories it offers customers in a one-stop-shop model. Increasingly scientists and clinicians want the confidence of obtaining devices, cables and other accessories from a single provider to ensure quality and reproducibility. Soterix Medical has a reputation for the highest quality devices and accessories for tDCS and HD-tDCS and it was important for us to collaborate with a partner such as Caputron Medical which has well known customer service and technical expertise in neurostimulation technologies.”

For more information contact:

Soterix Medical Kamran Nazim
Tel: +1-888-990-8327
Email: contact@soterixmedical.com

Caputron Medical Michael Ross
Tel: +1-646-926-3646
Email: Contact@Caputron.com

Soterix Medical Inc announces the launch of the mini-CT platform for Remote-Supervised Neuromodulation

New York City – Apr 01, 2015

Soterix Medical Inc.announces today the launch of its new mini-CT platform for remote-supervised noninvasive neuromodulation for transcranial Direct Current Stimulation (tDCS). The mini-CT represents a fundamental technological advance toward future home treatment with Electroceuticals by providing clinical researchers the first device, headgear, and electrodes for reproducible stimulation away form the clinic. The device will be validated through a series of clinical trials including for Multiple Sclerosis, ADHD, cancer-treatment related Cognitive Morbidities in adults and children, Migraine, and Palliative Pain Management with additional trials pending. The mini-CT device is available immediately for clinical trials. Initial clinical trials will also validate whether tDCS can be applied remotely but under strict clinical supervision without compromising tolerability or reproducibility.
Soterix Medical, Inc. (SMI) is the recognized leader in non-invasive neuromodulation with low-intensity stimulation and the release of mini-CT further underlines the company’s mission to advance the science of neuromodulation by providing the most advanced and rigorous technology. The mini-CT includes many proprietary technologies developed by Soterix Medical including Limited Total Energy (LTE), protocols for double blind clinical trials adapted from the 1x1-CT line (being used in all major multi-center tDCS trials), and several further innovations specific to remote supervised use. The use of LTE is especially critical under deployed environment and allows the device to automatically detect and correct for non-optimal conditions. These unique innovations include a singe-snap version of the Soterix Medical EASYstrap, which ensures consistent and reproducible electrode placement. The devices use a novel form of dose compliance control where the system cannot be activated until a single-use code is provided by the supervisor and the device recognizes proper configuration. The codes are unique and allow the remote supervisor to determine and adapt dose, as well as terminate sessions as needed. After trial end, stimulation history analysis for each code provided can be performed by the supervisor at the clinic.
Dr. Abhishek Datta, CTO of Soterix Medical comments “The design and release of the mini-CT platform is significant for the entire field of neuromodulation by being the first device that allows transcranial Direct Current Stimulation (tDCS) to be applied outside of the academic center and clinic. The rational is clear: the effects of tDCS are believed to increase with repeated use but regular visits to the treatment center are a burden for patients and their care-givers, as well as demanding for the clinical trial site. For a decade, the potential for tDCS as a technology that could be used at home was discussed, but all clinical grade systems like the Soterix Medical 1x1-tDCS was not suitable for deployed use. The mini-CT is the first clinical grade tDCS device that can be used outside of the clinic while maintaining the tolerability and reproducibility.”
David Berger, Product Engineer who led the mini-CT design process adds: “First and foremost in the design of any SMI product is incorporation of the most advanced medical technology to ensure consistent performance. But built into all SMI devices is also a transparency of function with only the more salient information and controls provided to the operator- this is the SMI open panel principle. But the design of the mini-CT presented fundamentally new challenges because the supervisor would no longer be in the same room as the subject. The ability to achieve reproducible remote supervised tDCS is a first and should accelerate and transform the advancement of neuromodulation.”

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

Media Contact Kamran Nazim
Tel: +1-888-990-8327
Email: contact@soterixmedical.com

Soterix Medical Inc. announces “BETTER” Clinical Trial for Treatment of Bipolar Depression

New York City – Jan 05, 2015

Soterix Medical Inc. announces today the BETTER trial for bipolar depression. Bipolar depression (BD) is a prevalent condition, with poor therapeutic options and a high degree of refractoriness. This justifies the development of novel treatment strategies, such as transcranial direct current stimulation (tDCS) with Limited Total Energy (tDCS-LTE) that showed promising results in clinical trials of unipolar depression. In the BETTER trial, sixty patients will be enrolled and assessed with clinical and neuropsychological tests in a randomized, sham-controlled, double-blinded trial using tDCS for refractory, acutely symptomatic BD (the bipolar depression electrical treatment trial, BETTER). The primary outcome is change (over time and across groups) in the scores of the Hamilton Depression Rating Scale (17 items). Biological markers such as blood neurotrophins and interleukins, genetic polymorphisms, heart rate variability, and motor cortical excitability will be assessed. Twelve anodal-left / cathodal-right 2mA tDCS-LTE sessions over the dorsolateral prefrontal cortex will be performed in 6 weeks. This landmark upcoming clinical trial will address the efficacy of tDCS-LTE for BD on different degrees of refractoriness. The evaluation of biological markers will also help in understanding the pathophysiology of BD and the mechanisms of action of tDCS. More trial information is available here.

Dr. Abhishek Datta, CTO at Soterix Medical summarizes “The BETTER neuromodulation study is noteworthy for its focus on bipolar depression. The most rigorous tDCS clinical trials, including two separate ongoing multi-center trials on Depression (ClinicalTrials.gov Identifier: NCT01562184 and NCT01894815) are using the Soterix Medical 1x1-CT platform with our exclusive LTE technology”. Dr. John Smith, Scientist at Soterix Medical further added “It is expected that once again world-class investigators chose Soterix Medical’s groundbreaking 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.”

CAUTION: tDCS is limited by Federal (or United States) law to investigational use only.

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 optimized for robust low-energy Transcranial Direct Current Stimulation. tDCS-LTE is under investigation in susceptible populations and is made possible through a proprietary adaptive stimulation limiting the voltage and power required for tDCS. It is the only non-invasive neuromodulation technology further optimized for robust deployment in a wide variety of environments including emergency medicine, home-use, etc.
Bipolar disorder: Bipolar disorder, also known as manic-depressive illness, is a brain disorder that causes unusual shifts in mood, energy, activity levels, and the ability to carry out day-to-day tasks. Symptoms of bipolar disorder are severe. They are different from the normal ups and downs that everyone goes through from time to time. Bipolar disorder symptoms can result in damaged relationships, poor job or school performance, and even suicide. If bipolar disorder can be treated, people with this illness can lead full and productive lives. People with bipolar disorder experience unusually intense emotional states that occur in distinct periods called "mood episodes." Each mood episode represents a drastic change from a person’s usual mood and behavior. An overly joyful or overexcited state is called a manic episode, and an extremely sad or hopeless state is called a depressive episode. Sometimes, a mood episode includes symptoms of both mania and depression. This is called a mixed state. People with bipolar disorder also may be explosive and irritable during a mood episode. Bipolar disorder can be present even when mood swings are less extreme. For example, some people with bipolar disorder experience hypomania, a less severe form of mania. During a hypomanic episode, you may feel very good, be highly productive, and function well. You may not feel that anything is wrong, but family and friends may recognize the mood swings as possible bipolar disorder. Without proper treatment, people with hypomania may develop severe mania or depression.

Media Contact Kamran Nazim
Tel: +1-888-990-8327
Email: contact@soterixmedical.com

Soterix Medical Awarded Patent for Limited Energy Neuromodulation

New York City – Nov 20, 2014

Soterix Medical Inc. announces receipt of allowance of claims from the U.S. Patent Office for an application covering Limited Total Energy (LTE) neuromodulation. The claims cover a system and method that allows reduction in power and voltage during brain stimulation, without compromising performance. View the original LTE paper here. LTE has broad applications from various forms of invasive (e.g. Deep Brain Stimulation, Vagus Nerve Stimulation) and non-invasive (transcranial Direct Current Stimulation / tDCS, transcranial Alternating Current Stimulation / tACS, transcranial Pulsed Current Stimulation / tPCS) where LTE provides automatic increased safety without reducing efficacy. LTE is available in Soterix Medical products including the 1x1-LTE, the 1x1-CT, and the REMOTE platform. LTE technology is being used in major ongoing clinical trials including two multi-center trials for major depression (Clinicaltrials.gov Identifiers: NCT01562184 and NCT01894815). LTE is especially useful in applications involving susceptible populations and high-throughput stimulation under various environments (REMOTE).

As described by Mr. Shiraz Macuff, Senior Development Engineer, “The simplest way to understand Limited Total Energy is to consider gears in a car. LTE is gears for neuromodulation- without LTE, undue power is used, which then strains the system. Gears don't change what a device does; it just makes it work better. Based on our experience supporting hundreds of medical centers, LTE was designed with high-throughput use in mind…it is an extra safety factor on our devices that already set the industry standard.”

CAUTION: tDCS is limited by Federal (or United States) law to investigational use only.

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 optimized for robust low-energy Transcranial Direct Current Stimulation. tDCS-LTE is under investigation in susceptible populations and is made possible through a proprietary adaptive stimulation limiting the voltage and power required for tDCS. It is the only non-invasive neuromodulation technology further optimized for robust deployment in a wide variety of environments including emergency medicine, home-use, etc. Soterix Medical Inc. was formed to develop and deploy innovative medical therapies. Founded in 2008, SMI is the world leader in clinical trials for non-invasive neuromodulation working with over 150 medical centers in the US and worldwide. Click here for a full listing of Soterix Medical clinical trials. SMI has licensed and developed a comprehensive intellectual property portfolio that includes High-Definition transcranial Direct Current Stimulation (HD-tDCS), innovative tDCS technologies, and Neurotargeting. From the most targeted non-invasive clinical systems to the most portable units, Soterix Medical provides clinicians and patients with unique and adaptable solutions. Ongoing Phase I, II, IIb, and III trials use investigational devices that are regulated/limited by US or Federal law.

Complete press release here

Media Contact Kamran Nazim
Tel: +1-888-990-8327
Email: contact@soterixmedical.com

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: 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.

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 in JAMA 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 Medical 1x1-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 paper here.

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 the separate 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. Announces the Launch of its New transcranial Direct Current Stimulation with Limited Total Energy (tDCS-LTE) Series of Products for Non-Invasive Neuromodulation

New York City – Jun 01, 2013

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, home-use, etc.
tDCS-LTE technology will be incorporated into a range of Soterix Medical neuromodulation products included the industry-standard 1x1 tDCS platform with the new Soterix Medical tDCS-LTE stimulator as well as into Soterix Medical Clinical Trials (CT) stimulators, which are the preferred choice for large and multi-center clinical trials. LTE provides further advantages for power management (e.g. device miniaturization) to support future generations of home-use systems. The technology puts tDCS in compliance with general FDA guidance on limited-output devices.
Dr. Abhishek Datta, CTO of Soterix Medical states: “Limited Total Energy is the most important advancement in tDCS stimulation technology in a decade and the first technology that specifically addresses concerns about future broad deployment in clinical centers and large trials. tDCS with LTE provides superior tolerability and reproducibility, so we expect this technology to be adopted in a range of future clinical trials. The combination of increased tolerability, increased performance, and reduced risks makes LTE the substrate for future clearance and adoption of tDCS. Technologies without LTE will simply underperform in the clinic and at home.”

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

Media Contact Narges Ghazi
Tel: +1-888-990-8327
Email: contact@soterixmedical.com

At Soterix Medical Inc., Engineering Serving Humanity means that we're committed to bring the most advanced medical technology into the hands of people who need it. The commitment underpins everything we do.

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