Soterix Medical receives Therapeutic Goods Administration Approval for Major Depression Treatment in Australia
Soterix Medical, Inc. (SMI) announced today that it had received Australia’s Therapeutic Goods Administration (TGA) approval for its Depression treatment system. This approval allows Soterix Medical to immediately begin marketing its the Depression tDCS-LTE™ therapy based on its proprietary transcranial Direct Current Stimulation (tDCS) technology for Major Depression in adults.
"The TGA certification represents our commitment to continue delivering our innovative technology and medical treatments worldwide", said Mr. Renato Moratore, VP Regulatory Affairs of Soterix Medical. "We will work closely with our Australian representatives to ensure our unique technology is provided with the exceptional customer support, Soterix Medical is recognized for. We look forward to working with medical centers and clinics to make Depression tDCS-LTE therapy readily available to patients across Australia."
Depression has the third highest burden of all diseases in Australia. It is estimated that in one in seven Australians will experience Depression in their lifetime. The Depression tDCS-LTE system is a non-invasive battery-operated device that delivers low-intensity electrical current through electrodes placed on the head. The therapy is available as a 30 minute in-office treatment.
Dr. Abhishek Datta, CTO of Soterix Medical, added, "The therapy works by delivering a low electrical energy that excites the part of the brain known to be hypo-active when suffering from major depression. With mild side-effects typically limited to itching and tingling only during the session, Depression tDCS-LTE therapy provides an effective alternative without the systemic side effects associated with oral antidepressants."
The immediate availability of Depression tDCS-LTE™ treatment provides Australian healthcare providers access to the Soterix Medical Treatment Partnership Program. This program has been adopted successfully by over 150 centers worldwide. Through the Treatment Partnership Program, Australian medical clinics can immediately contact Soterix Medical (at email@example.com) for a comprehensive support package including specialized education, on-site staff training, ongoing support, and treatment guidance.
tDCS-LTE by Soterix Medical is the only technology optimized for robust deployment in a wide variety of environments including emergency medicine, field-work, home-use, etc.
Soterix Medical Depression tDCS-LTE™ Therapy is non-systemic (does not circulate in the bloodstream throughout the body) and non-invasive (does not involve surgery) form of Neuromodulation.
Contact: Kamran Nazim