Motif Neurotech Receives FDA IDE Approval to Initiate RESONATE Trial of Motif XCS System in Treatment-Resistant Depression
Shots:
- The US FDA has granted IDE approval to initiate RESONATE Early Feasibility Study of Motif XCS System in pts with treatment-resistant depression, who have received ≥2 medications
- The trial will assess 12mos. safety of Motif XCS System & procedure post-implantation & measure symptom reduction, quality of life, anxiety, & cognitive function using standard assessments
- The Motif XCS System features a small, wirelessly powered implant placed in the skull over a validated depression target via a ~20-min outpatient procedure, designed to enhance safety while enabling brain-signal monitoring to guide personalized therapy
Ref: Businesswire | Image: Motif Neurotech | Press Release
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