Soterix Medical Inc., the global leader in stimulation and synergistic monitoring technologies, announced today it has received a 510(k) clearance from the U.S. Food & Drug Administration for its Intraoperative Neurophysiologic Monitoring (IOM) system, MEGA-IOM. The system provides unmatched integrated control of central and peripheral nervous systems to reduce postoperative risk and improve surgical outcomes. It includes preset modalities such as motor evoked potentials (MEP) to evaluate the integrity of motor pathways, somatosensory evoked potentials (SSEP) to evaluate the integrity of sensory pathways and detect brain and spinal cord ischemia, EEG to record and analyze brain activity (functional state of the brain), and direct stimulation to control the functional integrity of peripheral nerves.

"This FDA authorization represents a significant milestone for our organization as we can now offer the MEGA-IOM system to surgical teams across the U.S.," said Ms. Danielle Dadona, VP of Regulatory Affairs of Soterix Medical. "This U.S. manufactured system pairs with an intuitive, rich, software interface with exceptional usability."

Mr. Kamran Nazim, Chief Product Officer of Soterix Medical commented "MEGA-IOM is a cutting-edge modular platform solution that combines years of knowledge and experience obtained in clinical and research environments. Due to flexible channel configuration and size options (cart-based or portable), the system can meet the most exacting needs of both surgeons and advanced neuromonitoring specialists."

Surgeons, neurophysiologists, neurologists and intraoperative monitoring service companies in the United States interested in incorporating the MEGA-IOM system are eligible for Soterix Medical's Partnership program which includes support on the entire system, hands-on training and staff certification. Interested parties should contact Soterix Medical (at contact@soterixmedical.com) for additional information.

See full press release here.

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

Soterix Medical Inc., the global leader in non-invasive brain stimulation and synergistic monitoring technologies, announced the launch of MxN-GO EEG, a combined High Definition transcranial Electrical Stimulation (HD-tES) and EEG system with a unique untethered design. The system is intended for research applications requiring electrical stimulation and recording of brain activity in mobile and natural environments. The MxN-GO EEG features a lightweight, wire-free design for rapid set-up and ease of use. With 33 stimulation channels and 32 recording channels, the system provides unparalleled precision and application-specific targeting.

Soterix Medical, the pioneers in HD-tDCS/HD-tES, collaborated with mBrainTrain, the experts in research-grade mobile EEG, to create the ultimate solution for mobile hybrid stimulation/EEG studies.

HD-tES is an exclusive neuromodulation technology developed by Soterix Medical Inc. HD-tES 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.

Dr. Abhishek Datta, CEO of Soterix Medical commented "Soterix Medical was founded in 2008 to develop HD-tES as the first transcranial system capable of brain targeting with weak electrical stimulation. The MxN-GO EEG solution combines into one product our 16 years of leadership and innovation in High-Definition with the unmatched mobile EEG collection expertise of mBrain Train."

Dr. Ivan Gligorijevic, CEO of mBrainTrain commented "mBrainTrain and Soterix Medical engineers collaborated closely to develop the first wire-free wearable device with uncompromised EEG and HD-tES capabilities. For any application requiring high-quality EEG and rigorous stimulation control in a mobile platform, the MxN-GO EEG is the standard. We are excited to be moving the boundaries of brain therapy research and neuroscience together."

Dr. Datta adds, "Researchers and clinician-scientists recognize that brain science and medicine advancements increasingly depend on combining brain modulation and recording. And, moreover, that reproducibility and rigor absolutely depend on the quality of the equipment used. The MxN-GO EEG represents the state-of-the-art integrated EEG and HD-tES capabilities, in a remarkable wearable platform."

Researchers interested in learning more about the MxN-GO EEG system can contact Soterix Medical at contact@soterixmedical.com or visit https://soterixmedical.com/research/hd/mxn-go-eeg for more information.

CAUTION: Soterix Medical HD-tDCS / HD-tES platform is limited by Federal (or United States) law to investigational use only.

See full press release here.

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

Soterix Medical Inc., announces the launch of a Phase-2 clinical trial that will evaluate the combination of REMOTE-tDCS and a brain training program for the treatment of long COVID.The trial will be administered through NYU Langone Health's home-based remotely supervised (RS) tDCS program, which includes a clinical service that is available to patients across the United States.

Led by the National Institutes of Health (NIH), the Researching COVID to Enhance Recovery (RECOVER) Initiative was created to address the widespread and diverse impacts of long COVID. The specific study called RECOVER-NEURO will examine accessible interventions for cognitive dysfunction related to long COVID, including brain fog, memory problems and difficulty with attention, thinking clearly and problem solving. Interventions under this protocol include digital cognitive training program by Posit Science, the PASC-Cognitive Recovery, a web-based goal management training program, developed by Mount Sinai Health System, and the home-based transcranial direct current stimulation (tDCS) system designed by Soterix Medical for use in RS-tDCS. RECOVER-NEURO is expected to test a group of up to 315 participants.

Dr. Abhishek Datta, CEO of Soterix Medical commented that, "The Soterix Medical REMOTE-tDCS platform is the most validated hardware and software system for home-based tDCS. REMOTE-tDCS combines unique accessories, tDCS-LTE hardware, and telemedicine which can be customized for each clinical indication. NIH RECOVER-NEURO develops a Long COVID treatment based on digital therapy and Soterix Medical's REMOTE-tDCS platform."

"It's a great advance to see incorporation of tDCS treatment arms in the RECOVER initiative," said Dr. Leigh Charvet, PhD, professor in the Department of Neurology and director of the tDCS program at NYU Langone. "This trial was informed by previous findings that the combination of tDCS and online cognitive training can assist in recovery from long COVID, including improved cognitive function."

Mr. Kamran Nazim, Chief Product Officer of Soterix Medical adds, "Soterix Medical tDCS-LTE platforms have been shown in prior studies to improve cognition in healthy adults, and have shown promise in a variety of clinical conditions, including many conditions associated with cognitive or attention impairment or brain fog. Basic science studies have shown a dual action of tDCS-LTE deriving from both boosting brain plasticity and enhancing brain blood flow. This provides a strong rationale for testing tDCS-LTE for Long COVID."

More information about RECOVER-NEURO can be found at: https://trials.recovercovid.org.

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

See full press release here.

BACKGROUND:
tDCS-LTE by Soterix Medical is the only technology optimized for robust deployment in a wide variety of environments including emergency medicine, field-work, home-use, etc.

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

Soterix Medical Inc. (SMI), a global leader in non-invasive stimulation and synergistic brain monitoring technologies, announced today that patient recruitment for its treatment resistant depression trial funded by National Institute of Health has begun in New York City. For the trial, SMI is actively enrolling individuals who received but did not adequately respond to repetitive Transcranial Magnetic Stimulation (rTMS). Each trial site is responsible for reviewing prospective patients to determine if enrollment criteria is met by the individual.

SMI with technology licensed from Columbia University is developing a cloud-based targeting software based on parcel-guided rTMS (pg-rTMS). The pg-rTMS approach leverages anatomical magnetic-resonance-imaging (MRI), machine-learning (ML), and data from the Human Connectome Project (HCP) atlas, to design optimized personalized rTMS therapy.

Dr. Abhishek Datta, CEO and CTO of Soterix Medical explains, "Parcel-guided rTMS represents a major technical advance in rTMS therapy by combining three unique SMI technologies. One, Soterix Medical provides the unique FDA-cleared navigation system, not interrupted by line-of-site issues. Two, Soterix Medical has developed seamless cloud-based systems for neuromodulation optimization. And three, the TMS targeting approach developed by Columbia University provides the key to delivering rTMS therapy optimized to each patient's brain-circuit."

While conventional rTMS over the left dorsolateral prefrontal cortex is currently an FDA-approved treatment for treatment-refractory depression, it remains only partially effective with response and remission rates of ~41% and ~35% respectively. In a previous pilot study, pg-rTMS targeting a specific parcel of the HCP atlas led to a 100% treatment response in patients who were resistant to the conventional rTMS therapy.

Dr. Dennis Truong, Scientist at Soterix Medical and Principal Investigator of the project says, "We are excited for this next stage in the validation of parcel-guided rTMS therapy for depression. This trial is intended to confirm that personalized TMS delivery is crucial to deliver the fullest therapeutic value of TMS, to all patients, even those that did not respond adequately to conventional rTMS."

Prospective participants should contact Soterix Medical immediately at contact@soterixmedical.com to determine eligibility / obtain additional information.

See full press release here.

BACKGROUND:
Soterix Medical, Inc. received a 510(k) clearance from U.S. Food & Drug Administration (FDA) for the Neural Navigator system manufactured by Brain Science Tools, Netherlands in 2020. The system is intended for accurate positioning of the treatment coil during repetitive Transcranial Magnetic Stimulation (rTMS) device for treatment of Major Depressive Disorder (MDD). Additionally, in combination with Electromyography (EMG) and single pulse Transcranial Magnetic Stimulation (TMS), the Neural Navigator can be used to localize cortical motor areas of the brain. This clearance allows formal marketing in the US of the only Neuronavigation system for rTMS / TMS and motor mapping that is not affected by line-of-sight occlusion.

ABOUT SOTERIX MEDICAL:
Soterix Medical, Inc. (SMI) is a privately held medical device company that was formed to develop and deploy innovative medical treatments focused on neuropsychiatric and neurological disorders and rehabilitation. SMI provides researchers, clinicians, and patients with unique and adaptable solutions encompassing electrical, magnetic, and ultrasound stimulation and synergistic technologies. SMI holds multiple clinical approvals in US and worldwide. For more information, visit Soterixmedical.com.

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

Soterix Medical Inc. (SMI), a global leader in non-invasive neuromodulation and synergistic brain monitoring technologies, announced today that it has been awarded a Fast Track grant from the National Institute of Mental Health (NIMH). The award implements a personalized parcel-guided repetitive Transcranial Magnetic Stimulation (rTMS) approach through cloud-based targeting software and validates performance in clinical trials in patients with treatment resistant depression at Columbia University. The grant follows a pilot study demonstrating that rTMS targeting a specific parcel of the Human Connectome Project (HCP) atlas led to a 100% response in patients who were resistant to the standard 5-cm rule treatment. Soterix Medical’s award is for $910,000 over two years, expandable by an additional $1.4 million for follow-on pivotal clinical trials.

TMS over the left dorsolateral prefrontal cortex is currently an FDA-approved treatment for treatment-refractory depression but only partially effective, with response and remission rates of ~41% and ~35% respectively.

Dr. Dennis Truong, Scientist at Soterix Medical and Principal Investigator of the project says, "Using a proprietary parcel-guided targeting approach, we will develop a software enabling clinicians to perform rTMS procedures for their patients with higher accuracy. This novel technology may revolutionize the field of rTMS, with the potential to cure millions of people from debilitating depressive episodes, who would not otherwise recover. Our ultimate goal is to develop an FDA approved targeting algorithm for standard TMS-resistant Treatment resistant Depression.”

Soterix Medical already holds FDA clearance for Neuronavigation that is intended for the accurate positioning of treatment coil during rTMS. If successful, the final system will be a cloud-based application that can be integrated with any rTMS and Neuronavigation system.

R&D Engineer Mr. Alex Guillen adds, “Leveraging the Human Connectome Project atlas to guide personalized rTMS therapy is currently beyond the capability of conventional rTMS providers. Our cloud-based solution will enable practitioners to use this state-of-the-art targeting approach. Moreover, the software in principle would permit analogous targeting of alternative stimulation sites for other neuropsychiatric conditions.”

See full press release here.

BACKGROUND:
Soterix Medical, Inc. received a 510(k) clearance from U.S. Food & Drug Administration (FDA) for the Neural Navigator system manufactured by Brain Science Tools, Netherlands in 2020. The system is intended for accurate positioning of the treatment coil during repetitive Transcranial Magnetic Stimulation (rTMS) device for treatment of Major Depressive Disorder (MDD). Additionally, in combination with Electromyography (EMG) and single pulse Transcranial Magnetic Stimulation (TMS), the Neural Navigator can be used to localize cortical motor areas of the brain. This clearance allows formal marketing in the US of the only Neuronavigation system for rTMS / TMS and motor mapping that is not affected by line-of-sight occlusion.

ABOUT SOTERIX MEDICAL:
Soterix Medical, Inc. (SMI) is a privately held medical device company that was formed to develop and deploy innovative medical treatments focused on neuropsychiatric and neurological disorders and rehabilitation. SMI provides researchers, clinicians, and patients with unique and adaptable solutions encompassing electrical, magnetic, and ultrasound stimulation and synergistic technologies. SMI holds multiple clinical approvals in US and worldwide. For more information, visit Soterixmedical.com.

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

Soterix Medical Inc., a global leader in the design and production of smart devices treating neurological and psychiatric disorders, announces the successful partnership with Safe Toddles, a nonprofit committed to advancing access and education on assistive tools for blind toddlers. Together they obtained a Phase I Small Business Innovation Research award from the Institute of Education Sciences - US Department of Education with the goal of modernizing the pediatric belt cane through the addition of smart technology.

The first-generation pediatric belt cane was a purely mechanical device consisting of a belt attached with magnets to a rectangular frame that slides along the floor in front of the child. This first-generation cane along with a basic curriculum was developed by Safe Toddles. To enhance the capability of the wearable white cane to monitor motion and use that data to recommend a customized curriculum, Safe Toddles transferred exclusive rights for a “smart” pediatric belt cane to Soterix Medical Inc. Soterix Medical Inc. oversees all development of this next-generation cane, while Safe Toddles has continued to promote pediatric belt cane adoption and education.

Dr. Abhishek Datta, CEO and CTO of Soterix Medical summarizes “Our Phase I project was highly successful. We showed the feasibility of a smart belt capable of tracking the physical activity of children wearing the pediatric belt cane and a beta app incorporating the early intervention orientation and mobility curriculum for teaching the pediatric belt cane. We are grateful to the Institute of Education Sciences (IES) – US Department of Education (ED) for this award, allowing us to develop the smart belt prototype”. Mr. Yishai Valter, Product Engineer of Soterix Medical, adds, “The motion data was used in testing early concepts of integrating machine learning algorithms to our solution. Our ultimate goal is to recommend personalized lessons based on the subject’s walking performance.”

Dr. Grace Ambrose-Zaken, President of Safe Toddles adds “The wearable white cane is a transformative life-trajectory altering tool for visually impaired toddlers. And no blind child should be denied access to it. Our partnership allows Soterix Medical to leverage its 14 years of success in the design and manufacturing of medical devices to create the first smart wearable white cane. This allows Safe Toddles to focus on our mission of creating educational content and promoting research around the belt cane.”

Scope: The World Health Organization (WHO) estimates approximately 7 million children aged 1-5 years are severely visually impaired worldwide (2021). In the US alone, more than 150k toddlers are visually impaired (US Census Bureau, 2019). These children are in desperate need of an effective mobility tool.

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

Soterix Medical Inc., the global leader in non-invasive stimulation and synergistic technologies, announced today it has received a 510(k) clearance from the U.S. Food & Drug Administration for its monophasic Transcranial Magnetic Stimulation device, the MEGA-TMS system. The system is intended for the stimulation of peripheral nerves for diagnostic purposes.

Ms. Claudia Giselle, Soterix Medical’s VP Regulatory Affairs, explains “This FDA authorization represents yet another milestone for our organization. In combination with the previously cleared Electromyography (EMG) solution, users can now evaluate the integrity of spinal roots and peripheral nerves in a wide range of diseases. Additionally, this authorization clears all components needed individually for performing functional localization with motor mapping.”

Mr. Kamran Nazim, Chief Product Officer of Soterix Medical adds, "The clearance of MEGA-TMS reflects Soterix Medical’s commitment to continue to commercialize highly innovative non-invasive neuromodulation technologies for wider clinical use. The MEGA-TMS incorporates the highest maximum voltage rated capacitor in its class allowing generation of higher power single-pulse stimuli. With a big bright 7-inch LCD screen and a highly intuitive interface leveraging our renowned expertise in usability engineering, the system is already a step ahead of other magnetic stimulation devices.”

Soterix Medical already holds FDA clearance for Neuronavigation that is intended for the accurate positioning of treatment coil during repetitive Transcranial Magnetic Stimulation treatment for Major Depression. This latest FDA clearance provides Soterix Medical with among the widest portfolio of magnetic stimulation technologies spanning a range of diagnosis and therapeutic indications. The portfolio complements Soterix Medical offering of electrical neuromodulation and brain imaging products providing clinicians and researchers unparalleled brain modulation / imaging system integration.

Neurologists and Neurosurgeons in the United States interested in incorporating the MEGA-TMS system are eligible for Soterix Medical's Partnership program which includes support on the entire patient set-up pipeline, hands-on training and staff certification, data quality inspection, and connection to our network of physicians. Interested parties should contact Soterix Medical (at contact@soterixmedical.com) for additional information.

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

Soterix Medical Inc. (SMI), a global leader in non-invasive stimulation and synergistic technologies, announced today that it has been awarded a $1.48 million contract from Defense Advanced Research Program Agency (DARPA) to fully develop a technology for information transfer using alternative sensory modalities. This new technology solves a long-standing problem that US warfighters have been struggling with for decades. Whether it be a covert nighttime mission, a loud firefight with enemy forces or a difficult operation in a degraded visual environment (DVE) communication can be very difficult when visual or auditory signaling is impossible. The Phase-2 contract follows a Phase-1 contract that successfully validated the utility of this technology in university students in collaboration with the University of Colorado. This novel modality is based on a non-invasive electrical stimulation technique called Galvanic Vestibular Stimulation (GVS) that stimulates the vestibular nerve through the skin at the side of the head (mastoids). The Phase-2 contract involves collaborators from the University of Colorado, Tufts University, and Ohio State University. SMI will develop a commercial version of the device, known as the Spatial Positioning Actionable Intelligence Tool Leveraging: Galvanic Vestibular Stimulation (SPAITL:GVS TM) and complete certification testing. Validation testing will be performed in both university students and warfighters.

Mr. Yishai Valter, R&D Engineer, explains “This wearable device will be eyes-free, ears-free, and hands-free. Built-in Long Range Wide Area Network (LoRaWAN) integration will enable a commander to send messages from a distance to troops on a mission. It will be optimized for use by fighters in all environments and situations.”

“We are extremely pleased to have received this contract from DARPA. Soterix Medical is renowned for developing and commercializing innovative solutions and this award is a reflection of recognition of our commitment. Besides information transfer capability, we will also test GVS utility to mitigate motion sickness as part of developing a dual-use technology “ said Dr. Abhishek Datta, Scientist and CTO of SMI and Principal Investigator of the contract.

Soterix Medical already provides unique GVS technology to the investigational research market. The Soterix Medical GVS platform is the only system integrating optimized Vestibular HD electrodes, ergonomic headgear, and advanced waveform controls. The successful completion of this project will complete the development of a wearable, wireless GVS system offering a new set of capabilities for GVS research.

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

Soterix Medical Inc. the global leader in non-invasive stimulation and synergistic brain imaging technologies, announces an agreement with the Brazilian Government of Paraiba, State Department of Health (SES), for developing technology to assist patients under intensive care with Covid-19. The research is based on Soterix Medical’s proprietary High-Definition transcranial Direct Current Stimulation (HD-tDCS) platform, which is the only non-invasive and targeted electrical cortical stimulation technology.

The neurostimulation work will be carried out with Covid-19 patients admitted to the intensive care units (ICU) of regional medical centers, over an initial period of 6 months. According to the Secretary of Health, Geraldo Medeiros “what is expected is that the use of these devices will make the evolution and convalescence of these critically ill patients who are admitted to the ICU shorter and with fewer sequelae.”

Mr. Kamran Nazim, Chief Product Officer of Soterix Medical adds, "Soterix Medical’s technology has a global reach, consistent with our mission to develop noninvasive drug-free technologies for neurological disorders. This effort in Covid ICU patients leverages a unique aspect of HD-tDCS - a portable, battery-powered head-gear that allows focal transcranial targeting of brain regions.”

According to the State Department of Health Education advisor, Vanessa Cintra, with the research, Paraiba begins to open a range of treatment possibilities for patients with Covid-19 and even for post-covid patients and the repercussions of disease. Cintra adds “This is innovative research, but all the scientific evidence shows that there is no adverse effect and it does not hinder the treatment. It is an adjuvant treatment.”

The clinical trial leadership team includes Dr. Suellen Andrade of the Federal University of Paraiba who indicates “Our decision to work with Soterix Medical was based on the ability to used HD-tDCS in complex setting such as the Covid ICU, while allowing targeting activation of brain regions supporting recovery from Covid. Soterix Medical brings a world-class reputation to this advanced clinical trial.”

This effort builds on parallel trials by Soterix Medical to reduce the burden of Covid-19 including to address post-COVID neurological and psychiatric symptoms using at-home neuromodulation and home-based neuromodulation for depression.

CAUTION: Soterix Medical HD-tDCS platform is limited by Federal (or United States) law to investigational use only.

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

Soterix Medical Inc., the global leader in non-invasive stimulation and synergistic technologies, announced today it has received a Phase-1 contract from the National Aeronautics and Space Administration (NASA) to develop a portable spatial disorientation simulator to train astronauts.

Astronauts are at risk of spatial disorientation due to vestibular alterations during and following g-level transitions, such as landing on earth. This disorientation can be simulated using Galvanic Vestibular Stimulation (GVS) delivered at the mastoids using specialized electrodes and waveforms developed by Soterix Medical.

Mr. Yishai Valter, Soterix Medical’s Research and Development Engineer, explains “This contract is focused on developing a GVS system coupled with an Inertial Motion Unit (IMU) sensor. The system will consist of two independent channels that will allow delivering illusory motion in roll and pitch axes. The system will be wirelessly controlled using an application running on a tablet.”

Dr. Abhishek Datta, Chief Technology Officer of Soterix Medical and Principal Investigator of the project adds, "The award of the project reflects Soterix Medical’s mission to continue to develop highly innovative technologies. While we have historically served the medical market, this project presents a further opportunity to leverage our unique brain stimulation platforms to train astronauts so that they can better perform landing and recovery tasks. Besides NASA, this technology will potentially have used in the private aerospace market which is expected to grow dramatically in the next decade. We are also excited about the potential dual-use of the technology as GVS coupled with a motion sensor may have medical applications such as correcting impaired balance in Parkinson’s disease.”

Soterix Medical already provides unique GVS technology to the investigational research market. The Soterix Medical GVS platform is the only system integrating optimized Vestibular HD electrodes, ergonomic headgear, and advanced waveform controls. The successful completion of this project will complete the development of a next-generation wireless portable multi-channel GVS system offering a new set of capabilities for GVS research. The Phase 1 is focused on developing a functional prototype suitable for aerospace simulators, culminating in a pilot study validating system performance at the University of Colorado.

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

Soterix Medical Inc. the global leader in non-invasive stimulation and synergistic brain imaging technologies, announces a new clinical trial of home-based auricular Vagus Nerve Stimulation (taVNS) for individuals who experience post-COVID neuropsychiatric symptoms, like fatigue, headache, or anxiety. The trial involves an innovative, first-of-its kind home-based neuromodulation solution that combines Soterix Medical’s unique wearable taVNS platform, with ElectraRx^TM portal for remote stimulation control, and home-based vital sign monitoring.

Emerging studies show COVID can affect patients during two distinct phases of the disease process: the acute stage, characterized by fever, heart or lung problems, and the post-COVID phase, in which neuropsychiatric symptoms, like fatigue, anxiety and depression, can occur.

Researchers have used the term “neuroCOVID” to describe when the second phase is characterized by one or a combination of neuropsychiatric symptoms like vertigo, loss of smell, headaches, fatigue and irritability as well as anxiety and depression. Some studies estimate one in five COVID patients will develop these long-term symptoms.

The study is supported in part by the National Institutes of Health-funded Delaware Clinical and Translational Research Program to address neuroCOVID symptoms in patients. The trial is designed around a unique technology suite that combines precise vagus nerve stimulation with real-time remote-control as well as remote physiological sensing by the clinical team. The trial is based on the established anti-inflammatory response to vagus nerve stimulation.

Mr. Kamran Nazim, Chief Product Manager of Soterix Medical adds, "This study will leverage our unparalleled expertise in developing noninvasive technologies to stimulate the vagus nerve. Soterix Medical has over a decade of experience designing and deploying the more reliable, targeted, and intelligent non-invasive brain stimulation devices. Our proprietary remote-controlled taVNS system is uniquely optimized for this novel indication.”

Ms. Claudia Giselle, Soterix Medical’s VP Regulatory Affairs, adds “In addition to Soterix Medical’s unique wearable vagus nerve stimulation platform, this trial integrates technology for telemedicine support including video and real-time home-based blood pressure, pulse and oxygen saturation levels. The sophistication of this integrated system is a testament to our commitment to provide the most advanced stimulation and integrated monitoring technologies, for the most important medical indications of our time.”

CAUTION: Soterix Medical taVNS platform is limited by Federal (or United States) law to investigational use only.
See release here

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

Soterix Medical Inc. the global leader in non-invasive stimulation and synergistic brain imaging technologies, is pleased to report expanded clinical trials of its proprietary neuromodulation technologies for Alzheimer's disease and Mild Cognitive Impairment. Adults over age 65 represent the fastest growing population in the US. Decline in cognitive abilities is a hallmark of advanced age and is associated with loss of independence and dementia risk. Over 50 million adults worldwide are diagnosed with Alzheimer's disease or other dementia, which puts an enormous burden on individuals, their families and caretakers, and the healthcare system. Soterix Medical technologies are at the forefront of validation of non-invasive non-drug therapies not simply to both treat diagnosed Alzheimer's disease and Mild Cognitive Impairment but also stabilize, and even reverse, age-related cognitive decline.

With $6.2 million of support from the National Institutes of Health (NIH) National Institute of Aging (NIA), the Albert Einstein College of Medicine, Montefiore Health System, and the MJHS Health System will evaluate the effectiveness of tDCS to alleviate symptoms of Alzheimer's disease and improve brain function. This new trial will leverage Soterix Medical's unique at-home tDCS platform, the mini-CT stimulator and ElectraRx™ remote control software. The randomized, double-blind study will evaluate the effects of six months of at-home tDCS on improving cognitive performance and selected symptoms in 100 patients with mild-to-moderate Alzheimer's disease.

Since 2016, the NIH NIA has provided $5.7 million University of Florida Health and the University of Arizona, to test the efficacy of Soterix Medical's tDCS platform in slowing the process of age-associated memory loss and potentially prevent onset of dementia. The 360 participant Augmenting Cognitive Training in Older Adults (ACT Study) is a Phase III definitive multi-site randomized clinical trial to establish the benefit of delivering adjunctive tDCS with cognitive training in older adults to remediate the trajectory of age-related cognitive decline.

The Veteran's Administration and NIH are supporting two double-blind, randomized controlled trials in patients with mild cognitive impairment (146 subjects) or Alzheimer's disease (100 subjects) using Soterix Medical's proprietary High-Definition tDCS, a form of tDCS that can focally target brain regions.

Mr. Jose Rodriguez, Soterix Medical's VP Regulatory Affairs, explains "Soterix Medical is enthusiastic to support our medical partners around the world in conducting the most rigorous clinical trials for non-invasive neuromodulation in Alzheimer's disease and Mild Cognitive Impairment. We feel the funding support for these trials from government agencies such as the NIH and VA further supports their rigor and importance. And with the inclusion of state-of-the-art biomarkers testing, these trials can not only demonstrate efficacy, but prove target engagement."

Dr. Abhishek Datta, CTO of Soterix Medical adds, "The application of unique Soterix Medical technology to develop treatments for age-related cognitive decline demonstrates the versatile capabilities of our platforms. These include Soterix Medical SNAPpad™ and HD electrodes, by far the most successful and trusted tDCS electrodes, our capabilities to support the most controlled double-bind trials, and to provide unique delivery platforms both at medical centers and at-home."

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

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

Soterix Medical Inc. announces it has received FDA Investigational Device Exception (IDE) to launch a trial of transcranial Direct Current Stimulation-Limited Total Energy (tDCS-LTE) neuromodulation at-home for patients with Major Depressive Disorder (MDD). Soterix Medical developed proprietary technology supporting reliable home-based transcranial Direct Current Stimulation (tDCS) including the single-use SNAPpad™ electrodes that ensure clean and tolerated therapy at-home, and the ElectraRx™ digital healthcare platform that provides caregivers ongoing insight on patient response and full control of ongoing therapy.

Mr. Jose Rodriguez, Soterix Medical’s VP Regulatory Affairs, explains “The tDCS-LTE therapy is approved for treatment of Major Depression across the globe including Europe, Australia, Brazil, etc. It has been shown to be effective in trials including results published in the New England Journal of Medicine. The IDE approval for tDCS-LTE is a critical step to proving and providing treatment in the US.”

Dr. Abhishek Datta, CTO of Soterix Medical adds, "The home-based tDCS-LTE therapy continues our commitment to lead in the creation of innovative non-invasive neuromodulation treatments. Reliable home-use requires several unique technologies including our breakthrough mini-CT stimulator and SNAP accessories, proprietary LTE current management, and the simple and powerful ElectraRxTM portal.” That Soterix Medical pioneered home-based tDCS research with by far the most extensive track record on successful use was a factor in the FDA’s decision to approve the trial.

Major depressive disorder is highly prevalent and a leading cause of disability worldwide, but ~30% of patients do not benefit sufficiently from existing antidepressants. The current COVID-19 pandemic has made evident the urgent need for a reliable and effective home-based intervention for patients suffering from MDD. The Soterix Medical home-based trial benefits patients for whom access to rTMS or ECT depression therapy has been limited by the pandemic.

Dr. Leigh Charvet of NYU Langone Health, which is the lead clinical center for the trial explains “The NYU Department of Neurology has already established a remote tDCS therapy program based around Soterix Medical technology that address a range of brain disorders including Multiple Sclerosis, Parkinson’s, and mood disorders. The use of Soterix Medical equipment is essential to ensure reliable tDCS in telemedicine setting.”

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

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

Trial Contact: Claudia Giselle
Tel: +1-888-990-8327
Email: trials@soterixmedical.com

Soterix Medical Inc. (SMI), the global leader in non-invasive stimulation and synergistic technologies, announced today it has received a 510(k) clearance from U.S. Food & Drug Administration (FDA) for the Neural Navigator system manufactured by Brain Science Tools, Netherlands. The system is intended for accurate positioning of the treatment coil during repetitive Transcranial Magnetic Stimulation (rTMS) device for treatment of Major Depressive Disorder (MDD). Additionally, in combination with Electromyography (EMG) and single pulse Transcranial Magnetic Stimulation (TMS), the Neural Navigator can be used to localize cortical motor areas of the brain. This feature allows the use of the system for diagnostic purposes such as motor mapping to investigate functional reorganization after Stroke. This clearance allows formal marketing in the US of the only Neuronavigation system for rTMS / TMS and motor mapping that is not affected by line-of-sight occlusion.

“This FDA authorization represents a significant milestone for our organization as we can now offer the Neural Navigator system to rapidly increasing rTMS providers in the U.S.,” said Ms. Claudia Giselle, VP Regulatory Affairs of Soterix Medical. “The Neural Navigator has been designed to provide universal TMS compatibility, so this clearance sets the tone for additional formal approvals from the FDA.”

Mr. Kamran Nazim, Chief Product Manager of Soterix Medical commented that, “The FDA clearance of this system was based on clinical evidence showing tracking and navigation system accuracy better than the predicate device”. “Additional benefits include highly intuitive software workflow, light weight, and the smallest footprint in its class that allows fitting into tight spaces.”

Psychiatrists and Neurologists in the United States interested in incorporating the Neural Navigator system are eligible for the Soterix Medical's Partnership program which includes support on the entire patient set-up pipeline, hands-on training and staff certification, MR image processing / data quality inspection, and connection to our network of physicians. Interested parties should contact Soterix Medical (at contact@soterixmedical.com) for additional information.

Contact: Mariana Shuster
Tel: +1-888-990-8327
Email: contact@soterixmedical.com

Soterix Medical Inc. announced today the launch of its U.S. Food and Drug Administration (FDA) 510k cleared electro-detox™ treatment to reduce opiate and opioid withdrawal symptoms. The electro-detox™ is a battery-powered wearable device placed behind the patient’s ear that emits gentle current pulses to stimulate branches of specific cranial nerves. In the study leading to marketing approval, patients reported a symptom reduction of 62% within 20 minutes of using the device and a remarkable 88% transitioned to medication assisted therapy. Patients reported minimal to no side-effects from the treatment. Pharmaceutical medication has been the mainstay for the induction-phase or the initial phase when a patient begins the process of switching from the opioid of abuse to medication, but with varying levels of success and complications. The electro-detox™ system presents a non-drug, non-implantable medical device option with minimal side-effects, and is cost-effective.

Dr. Abhishek Datta, CTO of Soterix Medical commented that, "The launch of electro-detox™ treatment validates our continued commitment to deliver innovative technologies and medical treatments. It is known that discontinuation of opioid use is extremely painful and frightening, and that relapses during the induction phase are common. The electro-detox™ therapy reduces the fear of experiencing unpleasant withdrawal symptoms dramatically, with effects felt as quickly as 20 minutes. Since the declaration of public health crisis, Soterix Medical has been committed to combating the scourge of opioid addiction. We are extremely pleased to now provide a tool to support recovery from addiction".

Mr. Jose Rodriguez, Soterix Medical’s VP Regulatory Affairs, added "The electro-detox™ therapy requires minimal training and can be administered by physician extenders in addition to physicians. The device is available as of today by prescription. We look forward to working with addiction treatment centers and office-based clinics to make electro-detoxTM therapy readily available to patients across United States".

Physicians in the United States interested in providing Soterix Medical electro-detox™ therapy are eligible for the Soterix Medical's Partnership program which includes support on the entire patient treatment pipeline, hands-on training and staff certification, and connection to our network of physician researchers. Interested parties should contact Soterix Medical (at contact@soterixmedical.com) for additional information.

See full press release here

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

Soterix Medical Inc. has been awarded a Phase I NIH-SBIR contract from the National Institute of Drug Abuse (NIDA) of the National Institutes of Health (NIH) for the development of its portable remote-tDCS platform for the treatment of cocaine addiction. Soterix Medical is the industry leader in transcranial Direct Current Stimulation (tDCS) technologies. The Soterix Medical remote-tDCS platform is the only validated hardware and software system for reliable self-administered tDCS. The Icahn School of Medicine at Mount Sinai (ISMMS) is the partnering clinical center that will oversee a feasibility trial to be run at Samaritan Village, an outpatient rehabilitation center.

Soterix Medical's Phase I contract of approximately $475,000 extends over a period of 8 months supporting the application to Phase II award for a larger efficacy trial culminating in a FDA marketing trial. The focus of the project is to develop and validate the first self-administered electrostimulation system to reduce cocaine craving. The stimulation device and protocols developed in this project are further applicable to other addictive substances like nicotine, alcohol, and marijuana and to opioid misuse. Mr. Denis Arce, Product Development Engineer explains "The reproducible deployment of tDCS into outpatient and home settings requires intelligent hardware, easy-to-use accessories, and stimulation management software that all together make the remote-tDCS platform; the only platform validated for use in deployed settings through multiple rigorous trials. Our unique remote neuromodulation systems continues Soterix Medical's legacy as the technology leader in non-invasive brain stimulation."

"We are pleased to have received this support from NIH-NIDA. This is an important step in developing and commercializing our remote-tDCS platform for cocaine addiction" said Dr. Abhishek Datta, Ph.D., Soterix Medical CTO and the Principal Investigator on the award. "Furthermore, successful development of our unique non-addictive stimulation system potentially presents a solution to address the ongoing opioid epidemic as well. This contract from NIH-NIDA affirms the leadership of Soterix Medical in developing the most advanced deployable non-invasive brain stimulation technologies." Dr. Rita Goldstein, Ph.D. an internationally renowned cocaine addiction researcher is the Co-Investigator. She will spearhead the clinical trial, which will be performed by her team at Samaritan Village.

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

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

Soterix Medical Inc. announces receipt of allowance of claims from the U.S. Patent Office for an application covering advanced electrodes for all forms of non-invasive electrical stimulation including transcranial Direct Current Stimulation (tDCS). Soterix Medical is the established leader in applied non-invasive brain stimulation technology including the most advanced electrodes. Electrodes technology is essential for effective neuromodulation therapy providing Soterix Medical devices with unmatched performance. The claims cover hybrid magnetic-electro electrodes that complement the existing Soterix Medical state-of-the-art electrode technology portfolio. This additional patent confirms Soterix Medical’s patent portfolio as the strongest in the non-invasive neuromodulation industry.

As described by Mr. Mithlesh Dev, Senior Development Engineer, "For a decade, Soterix Medical has set the standard for electrode technology including creating High-Definition (HD) electrodes for HD-tDCS, the only platform for focal transcranial stimulation. The development of magneto-electrodes is yet another new category of electrode technology designed for deployability and efficacy."

Dr. Abhishek Datta, CTO of Soterix Medical continues, "This patent continues to build on our success in securing intellectual property for our unique product and services pipeline targeted toward neurological and neuropsychiatric disorders. Soterix Medical products stand far apart and ahead of competing systems because we continuously innovate and deploy new electrode technologies. This is why researchers and clinicians trust Soterix Medical devices to provide best-in-class performance across product categories."

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

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

Soterix Medical Inc (SMI) is pleased to report positive results from two double-blind, sham-controlled clinical trials of its proprietary transcranial Direct Current Stimulation-Limited Total Energy (tDCS-LTE) technology for the treatment of depression. The Depression tDCS-LTE system is unique in providing drug-free therapy with minimal side effects while maximizing energy delivery to the dorsolateral prefrontal cortex (DLPFC) region, which is implicated in depression control.

The first clinical trial reported tDCS-LTE was an effective, safe, and tolerable add-on intervention in patients with type I or II bipolar disorder in a major depressive episode and receiving a stable pharmacologic regimen. In this 59 patient randomized, sham-controlled, double-blind trial, tDCS-LTE produced an average 14-point improvement in Hamilton Depression Rating Scale (HDRS-17) scores, after just 12 treatments. The benefit persisted for over a month, with common side-effects no different than placebo. The results of the “Bipolar Depression Electrical Treatment Trial [BETTER]” were published in JAMA Psychiatry.

The second clinical trial reported tDCS-LTE to be superior to placebo producing an average 8 point decrease in the HDRS-17 after 15 consecutive weekdays of treatment (the induction phase), followed by 7 weekly treatments (the taper phase). In this 245 patient double-blind trial, patients received tDCS-LTE plus oral placebo, sham tDCS-LTE plus escitalopram (an SSRI drug), or sham tDCS-LTE plus oral placebo. The tDCS-LTE group had higher rates of itching or tingling, tinnitus, and nervousness than the other groups. The drug group side-effects included sleeplessness and severe constipation. At the trial endpoint, as the tDCS-LTE dose was tapered to weekly while escitalopram was maintained at a high daily dose, patients who received tDCS-LTE maintained significantly improved HDRS-17 scores compared to placebo while patients on high-dose escitalopram had slightly more improved HDRS-17 with noted side-effects. The results of the “ELECT-tDCS” trial were published in New England Journal of Medicine.

“We could not be more pleased with this series of controlled clinical trials,” commented Mr. Renato Moratore, VP Regulatory Affairs, “which validate Soterix Medical's commitment to developing technologies that provide unique benefits to patients and physicians. These proven benefits of tDCS-LTE as an add-on to drug therapy or a stand-alone treatment reflect years of scientific research and optimization by Soterix Medical engineers and clinical partners around the world.”

Mr. Kamran Nazim, Soterix Medical’s Chief Product Manager, added “There are two essential features of the Depression tDCS-LTE system that maximize efficacy through target engagement while simultaneously ensuring tolerability. The OLE electrode montage is optimized for DLPFC stimulation while the LTE power management ensures comfortable stimulation. These two controlled clinical trials confirm that the Soterix Medical tDCS-LTE system provides an unique and proprietary balance of effectiveness with minimal side-effects.

Physicians in the EU, Singapore, Australia, and Brazil interested in providing Soterix Medical Depression tDCS-LTE therapy are eligible for the Soterix Medical’s Partnership program which includes support on the entire patient treatment pipeline, hands-on training and staff certification, and connection to our network of physician researchers.

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

See full press release here

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

Soterix Medical, Inc. (SMI), announces that it has received Singapore’s Health Sciences Authority (HSA) approval for its non-invasive therapeutic medical device. This approval allows Soterix Medical to immediately market its products based on its proprietary transcranial Direct Current Stimulation (tDCS) technology in Singapore. The therapy works by delivering a mild electrical current through electrodes placed on the head relieving the symptom of Major Depression using the Depression tDCS-LTE™ treatment or Fibromyalgia using the PainX™ treatment. Patients who have not responded well to drug treatment are candidates for Depression tDCS-LTE or PainX treatment where typical adverse events are limited to mild itching and tingling. The therapy is available as a 20-30 minute in-office treatment.

"South East Asia is an important region for Soterix Medical", according to Chief Product Manager, Kamran Nazim. "HSA approval reflects our mission to deliver our treatment technologies worldwide and will build on our momentum and presence in these rapidly developing markets. This approval is a milestone toward securing approvals across Asia as a whole, including Japan, South Korea, China, and other countries to meet the rapidly escalating demand for advanced device-based therapies in the continent."

Renato Moratore, VP Regulatory Affairs added, "There is currently no medical device meeting the risk-benefit profile of Soterix Medical PainX™ and Depression tDCS-LTE™ treatment. We are pleased to secure approval for the benefit of the region's physicians and patients. Soterix Medical representatives throughout South East Asia remain committed to ensure every customer receives timely and insightful product support, consistent with Soterix Medical's standing as the international leader in non-invasive neuromodulation."

Similar to clinical approvals in other countries, Singaporean healthcare providers can now access the Soterix Medical Treatment Partnership Program. Interested parties should contact Soterix Medical (at contact@soterixmedical.com) for an in-depth support package including specialized education, on-site staff training, treatment guidance, and on-going support.

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

See full press release here

Contact: Max LoGuirato
Tel: +1-888-990-8327
Email: contact@soterixmedical.com

Soterix Medical, Inc. (SMI) announced today that it had received Australia's Therapeutic Goods Administration (TGA) approval for its Depression treatment system. This approval allows Soterix Medical to immediately begin marketing its the Depression tDCS-LTE™ therapy based on its proprietary transcranial Direct Current Stimulation (tDCS) technology for Major Depression in adults.

"The TGA certification represents our commitment to continue delivering our innovative technology and medical treatments worldwide", said Mr. Renato Moratore, VP Regulatory Affairs of Soterix Medical. "We will work closely with our Australian representatives to ensure our unique technology is provided with the exceptional customer support, Soterix Medical is recognized for. We look forward to working with medical centers and clinics to make Depression tDCS-LTE therapy readily available to patients across Australia."

Depression has the third highest burden of all diseases in Australia. It is estimated that in one in seven Australians will experience Depression in their lifetime. The Depression tDCS-LTE system is a non-invasive battery-operated device that delivers low-intensity electrical current through electrodes placed on the head. The therapy is available as a 30 minute in-office treatment.

Dr. Abhishek Datta, CTO of Soterix Medical, added, "The therapy works by delivering a low electrical energy that excites the part of the brain known to be hypo-active when suffering from major depression. With mild side-effects typically limited to itching and tingling only during the session, Depression tDCS-LTE therapy provides an effective alternative without the systemic side effects associated with oral antidepressants."

The immediate availability of Depression tDCS-LTE™ treatment provides Australian healthcare providers access to the Soterix Medical Treatment Partnership Program. This program has been adopted successfully by over 150 centers worldwide. Through the Treatment Partnership Program, Australian medical clinics can immediately contact Soterix Medical (at contact@soterixmedical.com) for a comprehensive support package including specialized education, on-site staff training, ongoing support, and treatment guidance.

BACKGROUND:
tDCS-LTE by Soterix Medical is the only technology optimized for robust deployment in a wide variety of environments including emergency medicine, field-work, home-use, etc.
Soterix Medical Depression tDCS-LTE™ Therapy is non-systemic (does not circulate in the bloodstream throughout the body) and non-invasive (does not involve surgery) form of Neuromodulation.

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

Soterix Medical, Inc. (SMI), the technology leader in non-invasive electrotherapy devices, announced today it has received a 510(k) clearance from U.S. Food & Drug Administration (FDA) for its IontoDC™ device intended to use a direct current to introduce ions of soluble salts or other drugs into the body.

“This clearance represents a significant milestone for our organization as we can now offer the IontoDC™ system to the medical community in the U.S.,” said Mr. Renato Moratore, VP Regulatory Affairs of Soterix Medical. “The IontoDC™ was designed for ease-of-use including simple controls and clear status displays.”

Dr. Abhishek Datta, CTO of Soterix Medical commented that, “The FDA clearance of this system builds on the reputation of Soterix Medical in providing equipment engineered to the highest medical device standards. The IontoDC™ technology is proven to provide exceptionally reliable and consistent performance.”

With the FDA clearance of the IontoDC™, Soterix Medical Inc. is announcing the addition of two Field Clinical Specialists to provide support to clinical centers including on-site product training, reimbursement, and customer needs.

The FDA cleared IontoDC™ device provides 10, 20, 30, or 40 minutes of Direct Current with an intensity of 1, 1.5, 1.75, or 2 mA. It includes current and resistance meters, automatic ramp up and down, and comes with an anode and cathode cable.

See full press release here

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

Soterix Medical, Inc. (SMI) announced today that it had received Brazil’s National Health Surveillance Agency (ANVISA) approval for its products. This approval allows Soterix Medical to immediately begin marketing its products based on its proprietary transcranial Direct Current Stimulation (tDCS) technology in Brazil.

This announcement reflects Soterix Medical’s commitment to continue to deploy our innovative technology and medical treatments focused on neuropsychiatric and neurological disorders not just in select countries, but worldwide, said Mr. Renato Moratore, VP Regulatory Affairs of Soterix Medical. “We will work closely with our distributor to introduce our unique technology in Brazil.”

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 software. From the most targeted non-invasive clinical systems to the most portable units, Soterix Medical provides clinicians and patients with unique and adaptable solutions. ANVISA approval also makes available Soterix Medical PainX™ and Depression-LTE™ treatment options which were already introduced in EU and Canada.

Ms. Pragya Bista, Product Engineer of Soterix Medical, added, “Our products stand out for their usability and Soterix Medical’s commitment to developing effective products for the clinic. The ANVISA approval allows us to bring our innovations directly to research and clinical centers across Brazil to advance tDCS research and treatment.”

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

BACKGROUND:
HD-tES including HD-tDCS is the only technology platform that allows tolerated non-invasive delivery of therapeutic current to desired brain regions.

tDCS-LTE is the only technology optimized for robust deployment in a wide variety of environments including emergency medicine, field-work, home-use, etc.

Soterix Medical PainX™ and Depression-LTE™ Therapies are non-systemic (does not circulate in the bloodstream throughout the body) and non-invasive (does not involve surgery) form of Neuromodulation.
Contact: Kamran Nazim
Tel: +1-888-990-8327
Email: contact@soterixmedical.com

Soterix Medical, Inc. (SMI) announced today the PainX™ treatment platformin Canada for Fibromyalgia and Migraine based on its proprietary transcranial Direct Current Stimulation (tDCS) technology. This announcement coincides with the receipt of Health Canada approval for the treatment of pain disorders in adults.

Soterix Medical PainX™ tDCS Therapy is a non-invasive battery-powered device that delivers mild current to a region of the cerebral cortex to either modulate reaction to painful experiences or control pain perception. PainX™ tDCS is a highly-promising therapy without the systemic side effects commonly associated with oral pain medications. Furthermore, it may present a valuable option for patients unresponsive to conventional treatment.

"One in five Canadian adults suffer from chronic pain. We are glad Soterix Medical can present this promising drug-free alternative," said Mr. Renato Moratore, VP Regulatory Affairs for Soterix Medical. "The Health Canada approval makes our unique tDCS technology now available in Canada."

Mr. Kamran Nazim, Chief Product Manager of Soterix Medical explains, "PainX™ system comprises of a small battery-powered stimulator that connects to a headgear that painlessly guides current from the scalp to intended brain regions. Soterix Medical team spent over 6 years testing and validating this platform to engineer a safe and effective system."

The Health Canada approval is based on 16 positive studies spanning 10 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.

The immediate availability of PainX™ treatment in Canada provides Canadian healthcare providers access to the Soterix Medical Treatment Partnership Program. This program has been adopted successfully by over 100 centers in the European Union. Through the Treatment Partnership Program, Canadian medical clinics can immediately contact Soterix Medical (at contact@soterixmedical.com) for a comprehensive support package including specialized education, on-site staff training, ongoing support, and treatment guidance.

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

Complete press release here

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
Soterix Medical
Christina Lam,
+1-888-990-8327
Email: contact@soterixmedical.com

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. 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, 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

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.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 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 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 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

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

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

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 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

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

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

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,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

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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