First NBT system delivered in US for Major Depression indication

Lighthouse | 16 August 2018

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  • Nexstim has reported its results for H118. The operational highlight was the first delivery in the US of a NBT (Navigated Brain Therapy) system for the treatment of Major Depression Disorder (MDD). The FDA approved the depression indication in 2017, and it was launched in May 2018. The use of rTMS (transcranial magnetic stimulation) in the treatment of depression is well documented and it is accepted as a safe and effective treatment, where NBT is differentiated to other devices is the accurate and reproducible navigation that underpins the platform.
  • Whilst an important step, and a useful validation of the NBT platform’s value, the bigger news flow will be the results of the important E-FIT trial for NBT in stroke rehabilitation. The study completed patient enrolment in January 2018 and is expected to report top-line results within three weeks. The stroke indication is a high value proposition, both clinically and commercially, and a positive outcome should lead to approval of the de novo 510(k) application. This would be transformative for Nexstim’s outlook.
  • Financially the results show net cash of €10.3m at June 2018, which with the current cash burn suggests funding is in place until Q219. However, additional investment is required to effectively commercialise the platform. We estimate that circa €15m is required to properly execute the commercialisation plans, notably for the stroke rehabilitation application, and to complete the clinical trial programmes.

Trinity Delta view: The value of Nexstim’s proprietary NBT platform is increasingly becoming visible. Whilst the first commercial delivery in the US for the depression indication is a useful milestone, the real value of the platform lies in the stroke rehabilitation indication. The major inflection point is rapidly approaching, with the results of the important E-FIT trial expected within circa three weeks. Assuming a positive outcome, the next stage will be to raise sufficient cash to implement a comprehensive commercialisation strategy and to progress the proposed clinical trial programme.



16 October 2018

Market Cap€20.0m
Primary exchangeHelsinki
Corporate clientYes

Company description

Nexstim has developed a proprietary navigated rTMS platform that is used in planning brain surgery (NBS) and has therapeutic uses (NBT) in stroke, depression, and chronic pain. FDA approval for depression was given in 2017; the stroke indication is awaiting the results of the follow-up E-FIT Phase III study.


Mick Cooper PhD
+44 (0) 20 3637 5042

Lala Gregorek
+44 (0) 20 3637 5043


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