Soterix Medical Inc. issued the following announcement on July 7.
Soterix Medical Inc. announces it has received FDA Investigational Device Exception (IDE) to launch a trial of transcranial Direct Current Stimulation-Limited Total Energy (tDCS-LTE) neuromodulation at-home for patients with Major Depressive Disorder (MDD). Soterix Medical developed proprietary technology supporting reliable home-based transcranial Direct Current Stimulation (tDCS) including the single-use SNAPpad™ electrodes that ensure clean and tolerated therapy at-home, and the ElectraRx™ digital healthcare platform that provides caregivers ongoing insight on patient response and full control of ongoing therapy.
Mr. Jose Rodriguez, Soterix Medical's VP Regulatory Affairs, explains "The tDCS-LTE therapy is approved for treatment of Major Depression across the globe including Europe, Australia, Brazil, etc. It has been shown to be effective in trials including results published in the New England Journal of Medicine. The IDE approval for tDCS-LTE is a critical step to proving and providing treatment in the US."
Dr. Abhishek Datta, CTO of Soterix Medical adds, "The home-based tDCS-LTE therapy continues our commitment to lead in the creation of innovative non-invasive neuromodulation treatments. Reliable home-use requires several unique technologies including our breakthrough mini-CT stimulator and SNAP accessories, proprietary LTE current management, and the simple and powerful ElectraRx™ portal." That Soterix Medical pioneered home-based tDCS research with by far the most extensive track record on successful use was a factor in the FDA's decision to approve the trial.
Major depressive disorder is highly prevalent and a leading cause of disability worldwide, but ~30% of patients do not benefit sufficiently from existing antidepressants. The current COVID-19 pandemic has made evident the urgent need for a reliable and effective home-based intervention for patients suffering from MDD. The Soterix Medical home-based trial benefits patients for whom access to rTMS or ECT depression therapy has been limited by the pandemic.
Dr. Leigh Charvet of NYU Langone Health, which is the lead clinical center for the trial explains "The NYU Department of Neurology has already established a remote tDCS therapy program based around Soterix Medical technology that address a range of brain disorders including Multiple Sclerosis, Parkinson's, and mood disorders. The use of Soterix Medical equipment is essential to ensure reliable tDCS in telemedicine setting."
CAUTION: tDCS is limited by Federal (or United States) law to investigational use only.
Original source can be found here.
