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 firstname.lastname@example.org) 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.