Welcome aboard, Nexstim! A leader in navigated stimulation of the brain; Nexstim has selected Clinipace to manage the US-based clinical trial for its Navigated Brain Therapy (NBT) System.
The Nexstim NBT System is the first and only FDA-cleared and CE-marked integrated navigated TMS (nTMS) mapping device. In addition to physiotherapy in stroke rehabilitation, Nexstim´s NBT System enables personalized, non-drug treatment of brain injury and disease using accurate and repeatable 3D-guidance of the therapeutic electric field.
Nexstim launched a novel NBT device in 2012 for the treatment of brain injury and disease using repetitive transcranial magnetic stimulation (rTMS) guided by a patient’s own MRI scan. While initial results show great promise in helping stroke patients regain lost motor control, the NBT System also enables personalized non-drug treatment for people suffering from clinical depression. The NBT System and therapeutic use for stroke and depression are not cleared indications in the US.
Rainer Harjunpää, Vice President, Quality Assurance and Regulatory Affairs said,
“Clinipace brings the right balance of regulatory and strategic development experience, working with global regulatory agencies to ensure we are compliant based on regional standards of care, standards of diagnosis, and other factors such as global marketing approval processes.”