29.03.2019 08:30:00 CET

Health Canada grants Nexstim NBS system and NexSpeech® medical device license for Canada

Company announcement, Helsinki, 29 March 2019 at 9.30 am (EET)

Health Canada grants Nexstim NBS system and NexSpeech® medical device license for Canada

Nexstim Plc (NXTMH:HEX, NXTMS:STO) ("Nexstim" or "Company"), the targeted neuromodulation company developing and marketing pioneering navigated personalised, non-invasive brain stimulation systems for diagnostics and therapy, announces that its NBS system and NexSpeech®  has received a medical device license from Health Canada.

The medical device license allows Nexstim to start marketing and selling the NBS system and NexSpeech ® in Canada. The Company has already signed a distribution agreement with a Canadian distribution company to bring its NBS System and NexSpeech® system to the Canadian market.

Nexstim's NBS system and NexSpeech® comprise a diagnostic device used for non-invasive localization of areas of brain controlling motor and speech function. Typically, they are used by neurosurgeons before operating patients with brain tumours or with treatment resistant epilepsy in order to plan the surgery so that maximum amount of brain tissue can be removed while the functionally important areas of the brain are left intact.

The NBS system and NexSpeech® use a unique method of TMS known as navigated Transcranial Magnetic Stimulation (nTMS) which allows for personalised, accurate, reproducible stimulation of the specific area of the brain.

Martin Jamieson, Chairman and CEO, Nexstim Plc commented: "We are pleased to announce that Nexstim NBS system and NexSpeech® has received the medical device license for Canada which is essential as we continue to focus on the Northern American market. With this license and the distribution agreement signed with Canadian Health Solutions we are now able to capitalise on the significant potential of our unique nTMS technology also in Canada.

Further information is available on the website www.nexstim.com or by contacting:
Martin Jamieson, Chairman and CEO
+44 771 516 3942

Sisu Partners Oy (Certified Adviser)
Jussi Majamaa
+ 358 40 842 4479

Citigate Dewe Rogerson            
David Dible/Shabnam Bashir/ Sylvie Berrebi
+44 (0)207 2822949 

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.

For more information please visit www.nexstim.com.

Canada medical device license for Nexstim NBS system and NexSpeech®