Press release, Helsinki, finland 27 June 2017, there is a 9.00
Nexstim Plc is applying for the FDA’s 510(k) approval in the united states
The NBT®system for
the treatment of depression
Nexstim Plc (NXTMH:HEX, NXTMS:STO) (“Nexstim” or the “company“), a medical device company that developed and markets a ground-breaking system to navigate a non-invasive brain stimulation for therapeutic and diagnostic applications, is pleased to announce that it has filed for 510(k) approval for its NBT®system for the treatment of major depressive disorder (MDD) by the us FDA, 26 June 2017.
Major depression is a recurrent and often chronic condition that affects 2-5% of the population in developed countries. The existing treatment, including medication and psychotherapy do not provide optimal results, because 20-40% of patients do not receive sufficient help. Neurostimulation by repetitive transcranial magnetstimulering (TMS) has been shown to be an effective method of treatment for patients who do not respond to drug therapy.
Nexstims chairman of the board and ceo Martin Jamieson comments on the application as follows: “The planned 510(k) application for the treatment of depression is an important milestone in implementing the company’s strategy, which focuses on creating significant business opportunities for the NBT®system in the united states. We look forward to be able to start marketing the NBT®system for the treatment of depression, where the existing treatment does not provide satisfactory results, during the beginning of 2018.”
NEXSTIM PLC
Martin Jamieson, chairman of the board and ceo
Additional information is available on the website
www.nexstim.com
or per telephone:
Nexstim +44 771 516 39 42
Martin Jamieson, chairman of the board and ceo martin.jamieson@nexstim.com
UB Securities Oy (Certified Adviser) +358 (0)9 2538 02 46
Citigate Dewe Rogerson +44 (0)207 2822949
David Dible david.dible@citigatedr.co.uk
About Nexstim Plc
Nexstim is a medical device company that developed and markets a ground-breaking system to navigate a non-invasive brain stimulation for therapeutic applications (NBT®system) and diagnostic applications (NBS-system). Nexstims NBS system is the first and only FDA-approved and CE-marked system to navigate transcranial magnetic stimulation (navigated Transcranial Magnetic Stimulation, nTMS) for mapping of the areas of motor skills and speech in the brain before a surgical procedure.
On the same technology platform the company has developed a system to navigate hjärnterapi (Navigated Brain Therapy, NBT®), which has received CE marking for the treatment of stroke, severe depression and chronic neuropathic pain. The NBT®system is currently undergoing additional Phase III trials (E-FIT) with 60 patients. Nexstim expects the trial ends the second quarter of 2018 and that the company then can request for authorization from the FDA. With the approval from the FDA would Nexstim able to begin marketing and selling the NBT®system for the treatment of stroke in the united states.
Nexstims shares are listed on Nasdaq First North Finland and Nasdaq First North Sweden. More information is available at www.nexstim.com.
Nexstim Abb is applying for the FDA’s 510(k) approval in the united states
