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Nexstim Receives Malaysian Authorization for Commercial Distribution of NBS System 6

NXTMHPress release07.07.2026 klo 09.00
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Company Announcement, Helsinki, 7 July 2026 at 9 AM (EEST)

Nexstim Receives Malaysian Authorization for Commercial Distribution of NBS System 6

Nexstim Plc ("Nexstim" or the "Company") has received authorization from the Malaysian Medical Device Authority (MDA) to market and distribute its NBS 6 for diagnostic and therapeutic applications in Malaysia.

The authorization enables Nexstim to commercialize NBS System 6 for pre-procedural mapping of the speech and motor cortices, treatment of MDD and chronic neuropathic pain, and post-operative motor rehabilitation following brain tumor surgery.

Introduced for therapy applications in Europe and the United States in 2023 and for diagnostic applications in 2025, NBS 6 combines Nexstim's proprietary SmartFocus® nTMS technology with a modular platform that can be tailored to a customer's clinical and research needs. The system enables customers to expand capabilities over time through a flexible and scalable platform.

Mikko Karvinen, CEO of Nexstim, comments: “We are pleased to receive this regulatory authorization in Malaysia, an important market in Southeast Asia. This approval allows us to introduce NBS 6 to neurosurgical centers and neuromodulation clinics seeking advanced solutions for brain mapping, therapy and rehabilitation. We look forward to working closely with our local partners to expand access to navigated TMS technology and support improved patient care in Malaysia.”

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 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.


Attachments
PRESS RELEASE_Malaysia Approval Final.docx.pdf