Soterix Medical’s PainX treatment platform, used to ease pain in fibromyalgia patients, has been approved in Canada as an in-office treatment. The therapy includes a non-invasive procedure featuring a mild electric current that is sent through the brain to alter pain signaling.
The method known as transcranial Direct Current Stimulation, or tDCS, has been explored in numerous conditions. The approval follows extensive research by Soterix showing that the PainX treatment can modulate the reaction to painful experiences or control pain as the patient perceives it.
“One in five Canadian adults suffer from chronic pain. We are glad Soterix Medical can present this promising drug-free alternative,” Renato Moratore, VP of regulatory affairs for Soterix Medical, said in a news release. “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.”
Side effects linked to the treatment are mild, particularly compared to the sometimes troubling side effects of pain medications. The most common side effects of the PainX treatment are itching and tingling. Headache is experienced in rare cases.
The small device is composed of headgear equipped with electrodes that transmit a current from the scalp to brain regions involved in pain signaling.
“Soterix Medical team spent over six years testing and validating this platform to engineer a safe and effective system,” said Kamran Nazim, chief product manager of Soterix Medical. Nazim stressed that approval by Health Canada is based on data from 16 studies that show PainX as effective treatment for pain in fibromyalgia, migraine, spinal cord injury, and other conditions.
The treatment produces rapid pain management. Benefits can range from three to 12 weeks after a treatment session.
Canadian healthcare providers can get immediate access to PainX through the Soterix Medical Treatment Partnership Program, which is up and running in Europe. The PainX platform received the CE Mark of approval in Europe earlier this year, indicating that it complies with European safety, health, and environmental regulatory requirements. It is not approved for use in the U.S.
Patients interested in testing the treatment can contact Soterix Medical directly.