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Soterix Medical receives ANVISA Medical Device Approval in Brazil for Neuromodulation products including PainX and Depression-LTE treatment

New York City – Apr 12, 2017

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

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

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