Nexstim Half-Yearly Report 1 January - 30 June 2017 (Unaudited)

Published: Aug 16, 2017

Company announcement, Helsinki, 16 August 2017 at 9:00 am

Company Highlights, January - June 2017

  • Patient enrolment for Nexstim's supplementary Phase III Trial in Stroke Rehabilitation (E-FIT) using its NBT® system is progressing well. The data, expected in Q2 2018, will be used for a de novo 510(k) filing with the FDA
  • Nexstim filed a 510(k) submission for its NBT® system for the treatment of depression with the US FDA in June
  • Fast progress in the long-term financing arrangement with Bracknor Investment and Sitra has resulted in a total of EUR 12.8 million in cash from share issues to date
  • NBS revenues amounted to EUR 1.1 million (2016: EUR 0.9 million)
  • Implementation of Nexstim's new U.S. distribution model is progressing; five new independent selling representatives

Business Overview

Nexstim is a medical technology company developing and marketing pioneering navigated non-invasive brain stimulation systems for both therapeutic (NBT® system) and diagnostic (NBS system) applications.

NBT

  • Nexstim's Navigated Brain Therapy (NBT®) system is the only Transcranial Magnetic Stimulation (TMS) system focusing on rehabilitation of hand and arm movement (upper limb motor disability).
  • Upper limb motor disability affects approximately 50% of stroke victims, with an estimated EU and US annual market size of USD 1.8 billion.
  • The NBT® system is CE marked for stroke rehabilitation. We anticipate that the E-FIT trial in the US will be completed in Q2 2018, allowing us to submit a de novo 510k to the FDA.
  • The NBT® system is also CE marked for major depression and chronic neuropathic pain. Nexstim has filed a 510(k) submission with the FDA for the NBT® system in the treatment of Major Depressive Disorder (MDD).


NBS

  • Nexstim's NBS system is the only CE-marked and FDA-cleared non-invasive solution for pre-surgical mapping of the motor cortex in brain cancer.
  • The non-invasive device has demonstrated a 46% increase in progression free survival in low grade gliomas versus the current invasive gold standard.
  • The NBS system has been sold to approximately 140 research universities and leading hospitals across the world.

CEO Martin Jamieson's review

I am delighted to report the important progress that Nexstim has made on multiple fronts during the first half of the year.

During the summer of 2016, Nexstim negotiated a long-term financing arrangement in the form of a joint deal with Bracknor Investment and The Finnish Innovation Fund, Sitra. The convertible bond and stand-by equity facility elements of this financing are now complete; the Company has raised a total of EUR 12.8 million in cash from share issues to date, including the first exercises of EUR 1.0 million in related warrants. As a result, at the end of H1 2017, Nexstim had a cash position of EUR 9.2 million. This compares very favourably to the cash position of EUR 1.8 million at the end of first H1 2016. The current cash balance, plus cash generated from sales, finance the Company until Q4 2018.

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