Medical company Soterix Medical Inc reported on Tuesday the receipt of the US FDA Investigational Device Exception (IDE) to commence the trial of transcranial Direct Current Stimulation-Limited Total Energy (tDCS-LTE) neuromodulation at-home for patients with Major Depressive Disorder (MDD).

According to the company, MDD is a leading cause of disability, but ~30% of patients do not benefit sufficiently from existing antidepressants.

COVID-19 has made evident the urgent need for a reliable and effective home-based intervention for patients suffering from MDD. The company's home-based trial benefits patients for whom access to rTMS or ECT depression therapy has been limited by the pandemic.

The company said it has 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 as well as the ElectraRx digital healthcare platform that provides caregivers ongoing insight on patient response and full control of ongoing therapy.

According to Jose Rodriguez, the company's VP Regulatory Affairs, the tDCS-LTE therapy is approved for treatment of Major Depression across the globe including Europe, Australia, Brazil, among others. 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.