FDA approves Motif Neurotech's first clinical trial for treatment-resistant depression

Motif Neurotech/DOT / Motif XCS System

The FDA approved an investigational device exemption for Motif's RESONATE early feasibility study, enabling the company to begin clinical trials of the XCS System, a wirelessly powered implant that stimulates brain regions linked to depression relief. The study will enrol adults with treatment-resistant depression who have not responded to two or more medications across up to eight US medical centres.

• FDA grants IDE approval for RESONATE early feasibility study of XCS System for treatment-resistant depression.
• Wirelessly powered implant requires only 20-minute outpatient procedure and targets brain region proven to reduce depression symptoms.
• Enrolment planned across eight major US medical centres including Baylor, Massachusetts General, Emory, and University of Iowa.