Press Release, Helsinki, 10 July 2026 at 9 AM (EEST)
Nexstim Receives Expanded Health Canada Approval for NBS 6 Diagnostics and Pain Applications
Nexstim Plc ("Nexstim" or the "Company") has received approval from Health Canada for a licence amendment expanding the approved indications of the NBS 6 to include diagnostic applications and the treatment of chronic neuropathic pain in Canada. The NBS 6 was previously approved by Health Canada for the treatment of Major Depressive Disorder (MDD) in 2024.
The expanded approval allows Nexstim to market and commercially distribute the NBS 6 in Canada for pre-procedural mapping of the speech and motor cortices of the brain, the treatment of MDD, and the treatment of chronic neuropathic pain.
Nexstim has maintained a presence in the Canadian market for several years . In March 2019, Health Canada granted medical device licences for the NBS System 5 and NexSpeech® for pre-procedural motor and speech mapping. Later that year, in December 2019, Health Canada approved the NBT® System for the treatment of Major Depressive Disorder.
Nexstim’s latest product generation, the NBS 6, was released for therapy use in Europe and the United States in 2023 and for diagnostic use in these markets in 2025. The NBS 6 is a modular platform built on Nexstim's proprietary SmartFocus® nTMS technology. The system combines diagnostic and therapeutic capabilities and can be configured to meet the needs of individual clinical and research users.
Mikko Karvinen, CEO of Nexstim, comments:
"We are pleased to receive this expanded approval from Health Canada, which broadens the commercial opportunities for NBS 6 in Canada. With approvals now covering diagnostics, MDD treatment and chronic neuropathic pain, we can offer Canadian customers access to a comprehensive navigated TMS platform that supports both diagnostic and therapeutic applications. Canada remains an important market for Nexstim, and we look forward to continuing our cooperation with our local partners and customers."
Further information is available on the website www.nexstim.com, or by contacting:
Mikko Karvinen, CEO
+358 50 326 4101
About Nexstim Plc
Nexstim is a Finnish, globally operating growth-oriented medical technology company. Our mission is to enable personalized and effective diagnostics and therapies for challenging brain diseases and disorders.
Nexstim has developed a world-leading non-invasive brain stimulation technology for navigated transcranial magnetic stimulation (nTMS) with highly sophisticated 3D navigation providing accurate and personalized targeting of the TMS to the specific area of the brain.
Nexstim’s Diagnostics Business focuses on commercialization of the NBS System 6, which 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’s Therapy Business markets and sells the NBS System 6 which is FDA-cleared for marketing and commercial distribution for the treatment of Major Depressive Disorder (MDD) in adult and adolescent patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode, and as an adjunct for the treatment of adult patients suffering from Obsessive Compulsive Disorder (OCD). In Europe, the NBS System 6 is CE-marked for the treatment of major depression, chronic neuropathic pain as well as post-operative rehabilitation of motor deficits of the upper limb.
Nexstim shares are listed on Nasdaq First North Growth Market Finland.
For more information, please visit www.nexstim.com.