Patients in Singapore with fibromyalgia-related migraines and other chronic pain will now be able to access Soterix Medical’s non-invasive therapeutic device, called PainX, as an alternative to treatment with medication.
The announcement was made following recent approval by Singapore’s Health Sciences Authority (HSA). Also approved was treatment with the company’s Depression tDCS-LTE medical device for symptoms associated with major depression.
Both PainX and Depression tDCS-LTE are based on Soterix’s proprietary trans-cranial Direct Current Stimulation (tDCS) technology, in which a mild electrical current is delivered to the head through electrodes. A special cap ensures that patches are correctly positioned.
PainX was developed to offer a new option in the management of chronic pain. The therapy delivers a low-intensity electrical current to parts of the brain responsible for abnormal pain sensation. In clinical trials, the device was shown to be safe and effective in treating fibromyalgia and migraines.
PainX is painless, and patients can carry out other activities while receiving treatment. Candidates for both new treatments include patients who have not responded well to drug treatment.
Typical adverse events with PainX or Depression tDCS-LTE include limited to mild itching and tingling.
The therapy is administered during a 30-minute in-office treatment. Usually, patients are advised to visit the doctor two to three times per week.
“South East Asia is an important region for Soterix Medical,” Kamran Nazim, chief product manager of Soterix, said in a press release. “HSA approval reflects our mission to deliver our treatment technologies worldwide and will build on our momentum and presence in these rapidly developing markets. This approval is a milestone toward securing approvals across Asia as a whole, including Japan, South Korea, China, and other countries to meet the rapidly escalating demand for advanced device-based therapies in the continent.”
Renato Moratore, vice president of regulatory affairs at Soterix, added, “There is currently no medical device meeting the risk-benefit profile of Soterix Medical PainX and Depression tDCS-LTE treatment. … We are pleased to secure approval for the benefit of the region’s physicians and patients.”
Healthcare providers in Singapore can now access the Soterix Medical Treatment Partnership Program to receive PainX or Depression tDCS-LTE. Those interested can email Soterix at firstname.lastname@example.org for a support package that includes specialized education, on-site staff training, treatment guidance, and ongoing support.
In the United States, the tDCS system is limited by law to investigational use only.