Soterix Medical, Inc. announced the PainX™ treatment platform for Fibromyalgia and Migraine based on its proprietary transcranial Direct Current Stimulation (tDCS) technology. This announcement coincides with the receipt of CE Mark approval for the treatment of pain disorders. PainX™ tDCS treatment is available immediately in the EU.
Soterix Medical PainX™ tDCS Therapy is a non-invasive, non-systemic device that delivers low-intensity direct current to a region of the cerebral cortex to either control perception of pain or modulate reaction to painful experiences. PainX™ tDCS is a highly-promising therapy for adults living with chronic pain without the systemic side effects commonly associated with oral pain medications. Moreover, it may present a valuable option for patients unresponsive to conventional treatment. The PainX™ therapy is the first tDCS system to incorporate control and safety features suitable for clinical deployment in the treatment of pain. PainX™ hardware is a battery-powered device that connects to a headgear that painlessly guides current to targeted brain regions during a short outpatient treatment session.
"We are glad Soterix Medical can bring light into the lives of patients suffering form chronic pain disorders," said Shani San Solo, VP Europe Business for Soterix Medical. "The CE approval allows our unique tDCS technology to provide an effective, safe and well-tolerated solution for the severe conditions like fibromyalgia, migraine, and other forms of chronic pain. This approval, coming soon after the CE approval of Soterix Medical 1x1 tDCS for Depression, reinforces the standing of Soterix Medical as the leader in non-invasive neuromodulation."
Dr. Abhishek Datta, CTO of Soterix Medical explains, "Many chronic pain disorders are associated with neuropathic pain, meaning pain that originates through maladaptive plasticity in the brain. The PainX™ tDCS therapy enhances adaptive plasticity encouraging correction of brain activity. Critical to the validation of a safe and effective treatment for pain, was over 5 years of design and testing of the PainX™ stimulator and headgear."
The CE mark decision is based on 14 positive studies spanning 8 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.
CAUTION: tDCS is limited by Federal (or United States) law to investigational use only
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.