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 Hanna Kotola, Vice President of Legal Affairs, has been appointed to undertake the wider role of Quality & Regulatory Affairs, in addition to her current role. Hanna will assume the new position of Vice President Legal, Quality & Regulatory Affairs with immediate effect.
Hanna Kotola joined Nexstim in June 2017 as Vice President of Legal Affairs and has broad international experience having held senior Legal and HR positions in Polar Electro Oy, Digita Oy and Nokia Oyj.
Hanna will be supported in her new extended role by Anna Honkanen, Senior Manager, Quality & Regulatory Affairs. Anna Honkanen has various relevant experience, most recently as an entrepreneur, consulting on quality management systems and regulatory affairs in In Vitro Diagnostic and medical devices companies. Prior to this, Anna acted as Vice President, Quality Management at Orion Diagnostica Oy, a Finnish producer for diagnostic tests systems, and as Director, Quality and Human Resources and Director, Quality Assurance at Oy Medix Biochemica Ab, a Finnish manufacturer of antibodies and diagnostic tests. Anna will join Nexstim on 17th October.
Martin Jamieson, Chairman and CEO, Nexstim Plc commented: “We are delighted to appoint Hanna Kotola to the position of Vice President Legal, Quality & Regulatory Affairs where she is well positioned to ensure the highest quality standards within Nexstim. We also look forward to welcoming Anna Honkanen to our Quality & Regulatory Affairs team. With these appointments, we are well positioned to progress our current and future regulatory filings as part of our strategy to commercialise the NBT® System for therapeutic applications in the US.”
Martin Jamieson, 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.