Soterix Medical said today it won Health Canada approval for and launched its PainX transcranial direct current stimulation technology designed for treating pain disorders in adults.
The PainX tDCS system is a non-invasive, battery-powered device designed to deliver mild current to a specific section of the cerebral cortex to modulate reaction to painful experiences or control pain perception, Soterix said. The company touted the device as a “highly-promising therapy” that avoids systemic side effects associated with oral pain medications.
“One in 5 Canadian adults suffer from chronic pain. We are glad Soterix Medical can present this promising drug-free alternative. 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,” regulatory affairs veep Renato Moratore said in a prepared statement.
Approval came based on data from 16 studies carried out over 10 years studying the device’s ability to treat conditions such as fibromyalgia, migraines and spinal cord injuries, the New York-based company said. Results indicated a sustained benefit from 3 to 12 weeks post-stimulation, with common side effects of itching, tingling and rare instances of headache, Soterix said.
“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,” chief product manager Kamran Nazim said in a press release.
The PainX treatment system will be available immediately in Canada, Soterix said.
Last December, Soterix Medical said it won CE Mark approval in the European Union for its 1×1 tDCS therapy system designed to treat major depressive disorder. The 1×1 tDCS system is a non-invasive therapeutic device that uses low-intensity direct current to stimulate a region of the cerebral cortex that controls mood, according to the company.