News & Updates

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), 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

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 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

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

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

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

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

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

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

See full press release here.

Media Contact:

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

Email: contact@soterixmedical.com

[Soterix Medical Inc.] (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.

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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

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Narges Ghazi
Email: contact@soterixmedical.com

Soterix Medical,Inc. announced today the completion of its Phase-1 Stroke-Aphasia trial using its revolutionary and proprietary non-invasive brain targeting platform called High Definition-Transcranial Direct Current Stimulation HD-tDCS.

Stroke is the fourth leading cause of death in the U.S. affecting 800,000 every year.

“We are proud to complete our Phase-1 trial. This is a major milestone for Soterix Medical and enhances our efforts to transform the way Stroke rehabilitation is managed. I wish to thank National Institute of Health for funding this study, the partnering clinical site of University of South Carolina and recognize each and every patient in our clinical trial” said Dr. Abhishek Datta, Chief Technology Officer, Co-Founder of Soterix Medical, and Co-Inventor of HD-tDCS. “We are thrilled to see the fruition of our vision of using small electrode arrays to deliver targeted stimulation to desired brain targets. Our patented approach allows individualized tDCS therapy and initial studies indicate more tolerable stimulation than conventional-tDCS using sponges”.

Soterix Medical has secured FDA-Investigational Device Exemption (IDE) in anticipation of a muti-site Phase-2 trial.

In a recent landmark study from the group that introduced tDCS in its current form, Dr. Michael Nitsche and Dr. Walter Paulus found that HD-tDCS produced larger and longer-lasting brain excitability changes than conventional-tDCS.

Background:HD-tDCS platform HD-tDCS was invented after years of compelling modeling evidence and comprehensive animal/ pre-clinical studies conducted at City University of New York (CUNY). Dr. Abhishek Datta spearheaded the modeling approach as part of his doctoral study at the CUNY laboratory of Dr. Marom Bikson and Dr. Lucas C. Parra. HD-tDCS was developed to combine the benefits of tDCS, namely low-intensity currents, safety profile, and neuromodulation plasticity with targeting control matching Transcranial Magnetic Stimulation - an FDA approved therapy. The HD-tDCS platform comprises either the basic 4-channel Adapter (4x1) or the advanced 8-channel Stimulator (MxN). HD-tDCS dose (electrode placement and individual electrode currents) is determined using individualized brain current-flow modeling in combination with the Neurotargeting Softwares: HDTargets and HDExplore.

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

See full press release here

Media Contact
Narges Ghazi
Email: contact@soterixmedical.com

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

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

For more on Soterix Medical HD-tDCS

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Narges Ghazi
Email: contact@soterixmedical.com

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

More about pediatric Down syndrome at NIH

For more on Soterix Medical HD-tDCS

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

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Narges Ghazi
Email: contact@soterixmedical.com

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

More details at NIH

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

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

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

Media Contact
Narges Ghazi
Email: contact@soterixmedical.com

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

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

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

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

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

About the Epilepsy Therapy Project

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

Media Contact
Narges Ghazi
Email: contact@soterixmedical.com

Soterix Medical Inc. 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