The US Food and Drug Administration (FDA) has granted Motif Neurotech an investigational device exemption (IDE) to initiate a study to evaluate its implant for treatment-resistant depression (TRD).
The brain-computer interface (BCI) company’s Motif XCS System implant delivers electrical stimulation to a brain region that has been clinically proven to reduce the symptoms of depression in adults who have not found relief from medication.
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Motif’s RESONATE early feasibility study will chiefly evaluate the safety of XCS following implantation over a 12-month period. It will also track whether enrolled patients experience meaningful reductions in their depression symptoms on the basis of widely used clinical assessments and monitor quality of life, anxiety, and cognitive function throughout the study.
“TRD is one of the leading causes of disability and suicide in the US and worldwide. Individuals with this condition have often tried a long list of medications and therapies and are still suffering. The RESONATE study gives us the opportunity to offer something genuinely new to people who have run out of options,” said Motif’s co-founder, Sameer Sheth.
“The device’s ability to stimulate and address dysfunctional brain circuits while avoiding direct contact with the brain will hopefully lead to safe and durable symptom improvement, in a form factor that patients find acceptable,” Sunil Sheth, also co-founder, added.
As per research published in the Journal of Clinical Psychiatry, almost three million Americans are estimated to be living with TRD, which is classified as a major depression that has failed to respond to at least two antidepressant regimens.
Selective Serotonin Reuptake Inhibitors (SSRIs), a class of prescription antidepressants, are often the first-line treatment for individuals suffering from depression. However, their efficacy can vary among patients, meaning implants could offer patients an alternative therapeutic avenue.
According to GlobalData analysis, the global neurology devices market is projected to reach a valuation of over $25 bn in 2034.
The prospect of applying neurostimulation for treating depression has attracted some of the medtech industry’s biggest players. In March 2025, Abbott kicked off its pivotal trial for a deep-brain stimulation (DBS) implant for addressing TRD.
Other companies are taking a different approach to treating depression, in the form of less invasive headsets that address depression with the delivery of transcranial direct current stimulation (tDCS). Flow Neuroscience’s Flow’s FL-100 headset, which uses tDCS, secured FDA clearance in December 2025.
