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Monday, 13 November 2017

Nexstim Oyj (FI) - Nexstim gains FDA clearance to commercialise its NBT® system in the US for the treatment of depression

Nexstim Oyj    

Published: 14:00 CET 13-11-2017 /GlobeNewswire /Source: Nexstim Oyj / : NXTMH /ISIN: FI4000102678

Nexstim gains FDA clearance to commercialise its NBT® system in the US for the treatment of depression

Company announcement, Helsinki, 13 November 2017 at 3 pm

 

Nexstim Plc (NXTMH:HEX, NXTMS:STO) ("Nexstim" or "Company"), a medical technology company developing and marketing pioneering navigated non-invasive brain stimulation systems for both therapeutic and diagnostic applications, announces that the Food and Drug Administration ("FDA") has cleared Nexstim's NBT® system for marketing and commercial distribution in the US for the treatment of Major Depressive Disorder (MDD).

 

MDD is a recurrent and frequently chronic disorder with significant unmet clinical need; 20-40% of patients gain insufficient benefit from current treatment options such as pharmacologic agents and psychotherapy. Stimulation of the brain through repetitive Transcranial Magnetic Stimulation (TMS) has been demonstrated to be effective in the treatment of MDD in patients who have failed pharmacologic treatment. MDD affects 2-5% of the population in developed countries.

 

The NBT® system uses a unique method of TMS known as navigated Transcranial Magnetic Stimulation (nTMS) which allows for accurate, reproducible stimulation of the specific area of the brain associated with the treatment of depression.

 

Nexstim intends to begin marketing and sales of its NBT® system in the US during H1 2018.

 

Martin Jamieson, Chairman and CEO, Nexstim Plc commented: "This FDA 510(k) clearance for our NBT® system is a critical milestone in the commercialisation of the device in the US.  We are confident that by highlighting the NBT® system's unique navigational capabilities, we will be able to clearly differentiate it from the non-navigational TMS devices currently on the market. We look forward to introducing the NBT® system for this important indication during H1 2018."

 

 

NEXSTIM PLC

Martin Jamieson, Chairman and CEO

 

Further information is available on the website www.nexstim.com or by contacting:

 

Nexstim                                            +447715163942

Martin Jamieson, Chairman and CEO martin.jamieson@nexstim.com

                                                                                                                                                      

UB Securities Oy (Certified Adviser)  +358 (0)9 2538 0246

 

Citigate Dewe Rogerson            +44 (0)207 2822949

David Dible/Isabelle Andrews/Shabnam Bashir david.dible@citigatedewerogerson.com

 

About Nexstim Plc

Nexstim is a medical technology company developing and marketing pioneering navigated non-invasive brain stimulation systems for both therapeutic (NBT® system) and diagnostic (NBS system) applications. Nexstim's NBS system is the only FDA cleared and CE marked system based on navigated Transcranial Magnetic Stimulation (nTMS) for the pre-surgical mapping of the speech and motor cortices of the brain. Based on the same technology platform, the Company has developed the Navigated Brain Therapy (NBT®) which is CE marked in Europe for the treatment of stroke, major depression and chronic neuropathic pain.

 

Nexstim has received clearance from the FDA for marketing and commercial distribution of its NBT® system for the treatment of Major Depressive Disorder (MDD) and looks forward to introducing the NBT® system for this important indication during H1 2018.

 

The NBT® system is currently in a 60 patient, supplemental Phase III study, E-FIT trial, for its use in stroke rehabilitation. The trial is expected to complete in Q2 2018, allowing Nexstim to file for FDA clearance. FDA clearance would allow Nexstim to start marketing and selling its NBT® system for stroke rehabilitation in the USA.

 

Nexstim shares are listed on the Nasdaq First North Finland and Nasdaq First North Sweden. For more information please visit www.nexstim.com

 



Nexstim FDA approval



This announcement is distributed by Nasdaq Corporate Solutions (One Liberty Plaza, 165 Broadway, New York, NY 10006. Tel: +1 212 401 8700. www.nasdaqomx.com) on behalf of Nasdaq Corporate Solutions clients. Source: Nexstim Oyj, Elimäenkatu 9 B, Helsinki FI 00510, Suomi
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