Beskrivning
| Land | Finland |
|---|---|
| Lista | First North Finland |
| Sektor | Hälsovård |
| Industri | Medicinteknik |
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Press release, Helsinki, 3 June 2026 at 10 AM (EEST)
Nexstim Plc ("Nexstim" or "Company") has received authorization for distribution of its NBS 6 system for use in diagnostics and post-operative rehabilitation by the Australian Therapeutic Goods Administration (TGA).
With the authorization granted by the TGA, Nexstim is allowed to start marketing and selling the NBS 6 system for pre-procedural mapping of the speech and motor cortices of the brain, as well as 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. Nexstim has been previously authorized to market and sell its NBS 6 system for use in treatment of major depression and chronic neuropathic pain in Australia.
Released for therapy use in Europe and the United States in 2023 and diagnostic use in the same markets in 2025, the NBS 6 is a new combination system built on Nexstim's unique, clinically established E-field navigated TMS (transcranial magnetic stimulation) technology. The modular system concept allows system capabilities to expand over time and be highly customized based on a customer’s research or clinical interests.
Mikko Karvinen, CEO of Nexstim, comments: “We are happy with our progress with regulatory approvals this year. This authorization by the Australian authorities is a good step forward among the US FDA clearances gained for the treatment of Adolescent Depression and Obsessive Compulsive Disorder (OCD), as well as the EU MDR certification received for the use of the NBS 6 in post-operative rehabilitation. We look forward to working to expand our presence in Australia with the updated product offering.”
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 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.