Nexstim Plc (NXTMH:HEX, NXTMS:STO) ("Nexstim" or "Company"), a medical technology company developing and marketing pioneering navigated non-invasive brain stimulation systems for both therapeutic and diagnostic applications, announces that Rainer Harjunpää has resigned from his role as Vice President, Quality Assurance & Regulatory Affairs, After Sales and Services, and as a member of the Management Team, effective as of 31 August 2017. Nexstim has started the recruitment process for a replacement.
Commenting on the change, Martin Jamieson, Chairman and CEO, Nexstim Plc stated: "We thank Rainer Harjunpää for the significant contribution that he has made to the Nexstim quality system as well as our regulatory affairs and after sales services during his eight years with the Company. Nexstim has built very solid foundations in these areas and as a result we are now well positioned to progress our current and future regulatory filings ahead of the planned US commercialisation of the NBT® system for therapeutic applications. We wish Rainer well for the future."
Martin Jamieson, Chairman and CEO
About Nexstim Plc
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. Nexstim's NBS system is the only FDA cleared and CE marked system based on navigated Transcranial Magnetic Stimulation (nTMS) for the pre-surgical mapping of the speech and motor cortices of the brain.
Based on the same technology platform, the Company has developed the Navigated Brain Therapy (NBT®) which is CE marked in Europe for the treatment of stroke, major depression and chronic neuropathic pain.
Nexstim recently filed a 510(k) submission with FDA for NBT® system for the treatment of Major Depressive Disorder (MDD). Nexstim looks forward to introducing the NBT® system for this important indication in early 2018. The NBT® system is currently in a supplemental Phase III study, E-FIT trial, which will recruit 60 patients. The trial is expected to complete in Q2 2018, allowing Nexstim to file for FDA clearance. FDA clearance would allow Nexstim to start marketing and selling its NBT® system for stroke rehabilitation in the USA.
Nexstim shares are listed on the Nasdaq First North Finland and Nasdaq First North Sweden.