Soterix Medical Launches PainX tDCS Treatment in Canada with Health Canada Approval

NEW YORK–(BUSINESS WIRE)– Soterix
Medical, Inc. announced today the PainX™
treatment platform in 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 to provide an
effective, safe and well-tolerated solution for chronic pain 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.

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