Press release, Helsinki, 19 February 2026 at 9 AM (EET)
Nexstim's NBS 6 system receives MDR certification in the EU for use in Post-Operative Rehabilitation
Nexstim Plc ("Nexstim" or "Company") has received certification for the use of its NBS 6 product for post-operative rehabilitation under MDR (Regulation (EU) 2017/745) in the European Union.
With the certification received, Nexstim is allowed to start marketing and selling the NBS 6 system within the European Union for the treatment of surgically induced new or worsening post-operative motor deficits of the upper limb as an adjunct therapy for motor rehabilitation in adult patients having undergone brain tumor surgery.
The Nexstim system can be useful in situations where a patient has surgery-related deficits that limit or worsen functional recovery. Navigated rTMS to the non-injured motor-cortex combined with physical therapy has been shown to improve post-operative rehabilitation in a multicenter study involving the neurosurgical departments from Heidelberg University Hospital, Technical University of Munich and Charité - Universitätsmedizin Berlin, Germany as well as King's College Hospital in London, UK and MD Anderson Cancer Center in Texas, US.
The NBS 6 is a new Nexstim product generation that due to its modular system design allows each device to be customized to fit the treatment or research needs of each customer. Nexstim has previously gained MDR certification for the use of its NBS 6 system in pre-surgical mapping of the speech and motor cortices of the brain, as well as in treatment of major depression and chronic neuropathic pain.
More information on Nexstim's solutions for post-operative rehabilitation available at https://www.nexstim.com/healthcare-professionals/post-operative-rehabilitation.
Mikko Karvinen, CEO of Nexstim, comments: "Our NBS 6 system has received great feedback from our customers, and we are excited to be able to offer additional functionalities as part of our product offering. It has been interesting to see an increasing amount of literature reflect our experiences of the positive effect of navigated rTMS in the treatment of post-surgical paresis. Part of our strategy extending to 2028 is to expand our therapy business through new indications. This is a great step for us in our strategic journey, and we are looking forward to our customers getting their hands on the new indication".
Further information is available on the website www.nexstim.com, or by contacting:
Mikko Karvinen, CEO
+358 50 326 4101
mikko.karvinen@nexstim.com
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 the United States. In Europe, the NBS 6 system 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
