The portable, patient-administered neuromodulation device utilizes a mild electrical current. It stimulates targeted brain areas resulting in a significant improvement in depressive symptoms.
“We are thrilled to receive this breakthrough designation from the FDA,” said Tuomas Neuvonen, Sooma CEO. “This designation recognizes that our device is a perfect solution, enabling a fast, effective and affordable treatment on a greater scale.
Neuvonen added that the company aims to make the treatment accessible to patients in U.S. “as quickly as possible.”
Sooma said its depression therapy offers a flexible treatment option with accessibility and affordability. It could benefit those underserved by medication or with limited access to psychotherapy.
The painless therapy involves no medication. It requires prescribing by a medical professional. The therapy features daily 30-minute sessions lasting a minimum of three weeks. Sooma said it also offers use as a standalone treatment or add-on therapy with pharmaceuticals.
According to the company, most patients feel relief around the third week of treatment. Postmarket data demonstrated that more than half of Sooma’s patients achieved a complete clinical response. That means a 50% or greater improvement in depressive symptoms after treatment.
Sooma said it plans to “work closely with the FDA” to bring the treatment to the U.S. market.