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The FDA has told Nexstim it may accept a “limited-sized” further trial plus additional analysis of the Phase III (NICHE) study. While this is positive for Nexstim – the FDA did not reject the application – it delays any approval to at least 2019. The new design is unlikely to be confirmed before H117. In our view, the uncertainty decreases the probability of success from 55% to 50%. Including the likely 2016 dilution, this decreases the indicative value from €0.96/share to €0.58/share. Nexstim should be funded until early 2018 on the current arrangements with Bracknor, but will then require further capital.
Underlying
Nexstim Ltd

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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Edison Investment Research
Edison Investment Research

Edison is an investment research and advisory company, with offices in North America, Europe, the Middle East and AsiaPac. The heart of Edison is our world renowned equity research platform and deep multi-sector expertise. At Edison Investment Research, our research is widely read by international investors, advisors and stakeholders. Edison Advisors leverages our core research platform to provide differentiated services including investor relations and strategic consulting.

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Analysts
Dr John Savin

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