Soterix Medical announced that 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.