The study will evaluate the efficacy and safety of the device, which is designed as a wearable cap. Credit: © 2025 Sooma Medical.
Sooma Medical has received the approval of an investigational device exemption (IDE) from the US Food and Drug Administration (FDA), allowing the company to initiate a pivotal study of its transcranial direct current stimulation (tDCS) medical device, Sooma 2GEN, as a home-based treatment for major depressive disorder (MDD).
The study will evaluate the efficacy and safety of the device, which is designed as a wearable cap that enables low-level electrical current delivery to the brain leveraging tDCS therapy.
This non-invasive technique aims to ease symptoms of depression eliminating the need for pharmaceuticals.
In collaboration with Lindus Health, Sooma Medical will conduct the trial involving 200 subjects across the US.
Lindus Health will leverage its virtual site offerings for subject recruitment and trial management, employing Citrus, its eClinical platform, for study-related activities.
Sooma’s portable neuromodulation device provides a flexible and accessible treatment option for individuals with MDD.
The device has already received breakthrough device designation from the US regulator. It claims to be a brain stimulation treatment that patients can utilise safely at home.
Sooma 2GEN is already cleared for treating the condition in 35 countries
The US trial’s positive outcomes are expected to further substantiate the device’s safety and efficacy, backing the company’s efforts to gain clinical validation for the tDCS therapy in the US market.
Sooma Medical CEO and co-founder Tuomas Neuvonen stated: “Until now, early-stage treatment options have been limited for patients who don’t respond to medication or lack access to therapy. Those who have tried several antidepressants without success are considered treatment-resistant, which affects their prognosis and hope for improvement.
“We’re excited to partner with Lindus Health to generate the US data that will demonstrate Sooma 2GEN’s capabilities in improving the quality of life in depression patients.”