Nexstim Plc Files 510(k) Submission for its NBT® system for the Treatment of Depression with US FDA
Company announcement, Helsinki, 27 June 2017 at 9 am
Nexstim Plc Files 510(k) Submission for its
NBT® system for the
of Depression with US FDA
Nexstim Plc (NXTMH:HEX, NXTMS:STO) ("
" or "
"), a medical technology company developing and marketing pioneering navigated non-invasive brain stimulation systems for both therapeutic and diagnostic applications, is pleased to announce it filed a 510(k) submission for its NBT® system for the treatment of Major Depressive Disorder (MDD) with the US FDA on June 26, 2017.
MDD is a recurrent and frequently chronic disorder affecting 2-5% of the population in developed countries. Current treatment options involving pharmacologic agents and psychotherapy are sub-optimal, with 20-40% of patients gaining insufficient benefit. Neuro-stimulation, by repetitive Transcranial Magnetic Stimulation (TMS) has been shown to be effective in treating depression in patients who have failed pharmacologic treatment.
Commenting on the submission, Martin Jamieson, Chairman and CEO, Nexstim Plc stated:
"This planned 510(k) submission for the treatment of depression is a further major milestone as we execute our strategy, which is centred on building a significant business for our NBT® system in the US. We are looking forward to being in a position to market our NBT® system for depression, an indication where current treatment options are sub-optimal, starting early in 2018."
Martin Jamieson, Chairman and CEO
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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 for the treatment of stroke, major depression and chronic neuropathic pain. The NBT® system is currently in a supplemental Phase III study, E-FIT trial, which will recruit 60 patients. 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
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Source: Nexstim Oyj via GlobeNewswire