Press release, Helsinki, 9 April 2019 at 10.00 am (EET)
Nexstim Plc (NXTMH:HEX, NXTMS:STO), the targeted neuromodulation company developing and marketing pioneering navigated personalised, non-invasive brain stimulation systems for the treatment of Major Depression Disorder (MDD), today announces that it has renewed EC certificate for all the company’s systems.
The new certificate covers the NBS System, Speech mapping module, Transcranial Magnetic Stimulator and NBT® System for MDD and chronic neuropathic pain.
The EC Certificate demonstrates that the company’s quality system has been evaluated and has fulfilled the EU requirements relating to a product bearing a CE marking. Nexstim received its first EC certificate in 2006. Renewal of the certificate requires yearly audits of the company’s quality system. The new EC Certificate, and hence the company’s systems CE-marks, will be valid from 11th April 2019 until April 2024, allowing Nexstim to market and sell its systems in the European Union.
Nexstim’s EC Certificate is being issued by Eurofins Expert Services, a company designated to assess whether manufacturers and their medical devices meet the requirements set out in EU legislation.
Further information is available on the website www.nexstim.com or by contacting:
Nexstim
Martin Jamieson, Chairman and CEO
+44 771 516 3942
martin.jamieson@nexstim.com
Citigate Dewe Rogerson
David Dible/Shabnam Bashir/ Sylvie Berrebi
+44 (0)207 2822949
david.dible@citigatedewerogerson.com
About Nexstim Plc
Nexstim is a medical technology company focused on the development and commercialization of its world-leading SmartFocusTM TMS technology, a non-invasive brain stimulation system for the treatment of Major Depressive Disorder (MDD). The Company’s proprietary Navigated Brain Therapy (NBT®) system, a highly sophisticated 3D navigation, is the only personalised, navigated transcranial magnetic stimulation (TMS) approach providing accurate targeting of the TMS to the specific area of the brain associated with MDD.
Nexstim’s NBT® system has been launched in the US for the treatment of MDD following clearance from the FDA for marketing and commercial distribution for this indication. The NBT® system is CE marked in Europe for the treatment of major depression and chronic neuropathic pain.
In addition, Nexstim is commercialising its Navigated Brain Stimulation (NBS) system for diagnostic applications, based on the same technology. The NBS system is the only FDA cleared and CE marked navigated TMS system for pre-surgical mapping of the speech and motor cortices of the brain. Nexstim shares are listed on the Nasdaq First North Finland and Nasdaq First North Sweden.