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Clinipace Brings Strategic Level of Global Regulatory and Development Experience to Novel Therapy Trial
Nexstim, a Finland-based compant involved with image-guided transcranial magnetic stimulation, has selected Clinipace Worldwide to manage the US-based clinical trial for the Navigated Brain Therapy System.
Nexstim launched a novel NBT device in 2012 for the treatment of brain injury and disease using repetitive transcranial magnetic stimulation (rTMS). The company reports that initial results show promise in helping stroke patients regain lost motor control, and that the NBT System also enables personalized non-drug treatment for people suffering from major depressive disorder (clinical depression).
Though the NBT System meets the requirements of the European Medical Devices Directive (MDD) and has been CE marked, the NBT System and therapeutic use for stroke and depression are not cleared indications in the US.
Read the full release here.