Nexstim: E-FIT stroke trial results disappoint
Nexstim has reported that the pivotal E-FIT stroke trial did not show a clinically significant difference between active and sham treatment groups. The disappointment is particularly marked as the approach was technically so promising. A positive outcome would have led to the FDA approving Nexstim’s proven proprietary rTMS platform for the rehabilitation of stroke patients. Management intends to focus resources on commercialising the depression indication in the US and Europe. Whilst the strategic options are evaluated we are suspending our forecasts and valuation.Nexstim Oyj. Nexstim Oyj is a Finland-based medical technology company. It is focused on improving rehabilitation for stroke patients through the use of noninvasive brain stimulation. Its offering comprises: a diagnostic tool for brain surgery planning, Navigated Brain Stimulation (NBS) System, which comprises navigated transcranial magnetic stimulation (nTMS) device for presurgical mapping (PSM) of the motor and speech cortices; and a device for stroke therapy called Navigated Brain Therapy (NBT) System, which focuses stimulation on targeted locations in the brain in order to enhance rehabilitation process. The NBT System targets upper limb motor disability and is under Phase III pivotal clinical trial study at rehabilitation sites in the United States. The Company's systems are used in over 100 facilities in research, therapy and neurosurgical planning purposes. Nexstim Oyj has two subsidiaries: Nexstim Inc and Nexstim Germany GmbH.
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