Sooma Medical announced today that it received FDA investigational device exemption (IDE) for its transcranial direct current stimulation (tDCS) device.
The company can now begin a pivotal study of the medical device with the IDE.
Helsinki, Finland–based Sooma designed the tDCS device to treat depression through portable neuromodulation. Worn as a cap, the device uses a non-invasive technique that stimulates the brain with a mild electrical current. This can alleviate depression symptoms without the need for pharmaceuticals.
Sooma’s prescription-only therapies can work as a standalone treatment or in combination with other treatment types. The company says it’s also one of the few brain stimulation therapies patients can safely use at home.
The technology won FDA breakthrough device designation just over two years ago. Sooma says that, with its IDE study, it now seeks full FDA approval for the device. The device already has clearance to treat MDD in 35 countries worldwide.
This study looks at the device — called the Sooma 2GEN – in improving major depressive disorder (MDD) as an at-home treatment. Sooma expects to enroll around 200 participants across the U.S., conducting the trial in collaboration with Lindus Health.
“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,” said Tuomas Neuvonen, co-founder and CEO at Sooma. “We offer an effective and accessible approach to treating MDD, ensuring everyone with depression receives the right treatment that suits their individual needs. We’re excited to partner with Lindus Health to generate the U.S. data that will demonstrate Sooma 2GEN’s capabilities in improving the quality of life in depression patients.”
