Nexstim granted authorization for commercial distribution of NBS system in Australia

Helsinki, FINLAND


Press release, Helsinki, 18 May 2021 at 10 AM (EEST)

Nexstim granted authorization for commercial distribution of NBS system in Australia

Nexstim Plc (NXTMH:HEX, NXTMS:STO) ("Nexstim" or "Company) announces having received authorization for distribution of its NBS system by the Australian Therapeutic Goods Administration (TGA).

The medical device license allows the company to start marketing and selling NBS systems in Australia to be used for neurosurgical applications.

Nexstim’s NBS System is the only FDA cleared system based on navigated Transcranial Magnetic Stimulation (nTMS) for non-invasive mapping of the speech and motor cortices of the brain. The NBS system is used, for example, after a patient has had a diagnosis of a brain tumor or other disorder and when the lesion is thought to be close to functional areas of the brain - such as those responsible for speech production and limb movement. Brain maps from NBS can be invaluable when deciding the best treatment option for the patient.

Mikko Karvinen, CEO of Nexstim, commented: This medical device license in a new market helps us advance towards our strategic objective of achieving profitable revenue growth. Our NBT® system has already earlier been granted a medical device license by the Australian government and we are now happy to be able to distribute systems for both diagnostic and therapeutic use in Australia from now on.”

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 medical technology company. Our mission is to enable personalized and effective therapies and diagnostics for challenging brain diseases and disorders.

Nexstim has developed a world-leading non-invasive brain stimulation technology called SmartFocus®. It is a navigated transcranial magnetic stimulation (nTMS) technology with highly sophisticated 3D navigation providing accurate and personalized targeting of the TMS to the specific area of the brain.

SmartFocus® technology is used in Nexstim’s proprietary Navigated Brain Therapy (NBT®) system, which is FDA cleared for marketing and commercial distribution for the treatment of major depressive disorder (MDD) in the United States. In Europe, the NBT® system is CE marked for the treatment of major depression and chronic neuropathic pain.

In addition, Nexstim is commercializing its SmartFocus® based Navigated Brain Stimulation (NBS) system for diagnostic applications. 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 Growth Market Finland and Nasdaq First North Growth Market Sweden.

For more information please visit www.nexstim.com

Attachment



Pièces jointes

Nexstim_Press release_Aus approval_18052021_FINAL