Company announcement, Helsinki, 22 May 2018, at 9:00 AM Nexstim Plc - first NBT® system for depression ordered in the US
Nexstim Plc (NXTMH:HEX, NXTMS:STO) ("Nexstim" or "Company"), the targeted neuromodulation company developing and commercializing its world-leading navigated non-invasive brain stimulation technology for therapeutic and diagnostic applications, announces that it has agreed to deliver its first Navigated Brain Therapy (NBT®) system in the US to Island Psychiatry, a private practice that provides accessible, high quality comprehensive mental healthcare on Long Island, New York. The placement follows Nexstim's launch of the SmartFocus TM TMS technology at the Clinical TMS (transcranial magnetic stimulation) Society Annual Meeting in New York, which took place from 11-13 May.
Island Psychiatry uses a Unified Specialities Approach that brings a variety of disciplines together to provide appropriate assessment and treatment including TMS for major depressive disorder for each individual patient. TMS is used to stimulate and increase the activity of an area of the brain called the left dorsolateral prefrontal cortex (DLPFC), where metabolic activity is reduced in depression. Island Psychiatry will use the NBT® system to provide patients with personalised navigated TMS therapy.
Nexstim received FDA approval in November 2017 allowing practices like Island Psychiatry to provide patients with personalised navigated TMS therapy. Nexstim's NBT® system is based on its unique SmartFocus TM TMS technology and is the only FDA approved personalised navigation approach for accurate targeted TMS in Major Depressive Disorder (MDD). This is achieved through its 3D navigation system, personalised based on a patient's MRI scan.
Martin Jamieson, Chairman and CEO, Nexstim Plc commented: "We are delighted to announce that Island Psychiatry, a leader in TMS depression therapy in the US, will be the first clinic using our NBT® system in the US. Placing this first system in the US marks an important milestone for us and we look forward to working with the center to generate case studies that highlight the beneficial impact that our personalised approach delivers to patients with depression."
NEXSTIM PLC Martin Jamieson, Chairman and CEO
Further information is available on the website www.nexstim.com or by contacting:
Nexstim Martin Jamieson, Chairman and CEO +44 77 1516 3942 martin.jamieson@nexstim.com
Sisu Partners Oy (Certified Adviser) +358 (0)10 231 4560
Citigate Dewe Rogerson +44 (0)207 2822949 David Dible/Shabnam Bashir/Isabelle Andrews david.dible@citigatedewerogerson.com
About Island Psychiatry Island Psychiatry is a diverse group of mental health practitioners that bring a unified specialties approach to diagnose and treat a broad range of psychiatric disorders in children, adolescents, and adults in the Long Island, New York area. For more information, visit https://islandpsychiatry.com/
About Major Depressive Disorder (MDD) and Navigated Brain Therapy (NBT®) Major Depressive Disorder (MDD) is a recurrent and frequently chronic disorder with significant unmet clinical need. Approximately 10 million Americans suffer from Major Depressive Disorder (MDD) annually and 35% of patients treated with anti-depressant drugs fail to respond to this method of treatment.
Nexstim's NBT® therapy provides personalised non-invasive neuro-stimulation therapy as an alternative to sub-optimal pharmacologic treatments via its SmartFocus TM TMS technology.
About Nexstim Plc Nexstim is a targeted neuromodulation company focused on developing and commercializing its world-leading navigated non-invasive brain stimulation technology, known as SmartFocus TM TMS (transcranial magnetic stimulation), for therapeutic applications, namely stroke, depression and chronic pain via its Navigated Brain Therapy (NBT®) system.
Nexstim has launched its NBT® system in the US for the treatment of Major Depressive Disorder (MDD) following clearance from the FDA for marketing and commercial distribution for this indication. The NBT® system is CE marked in Europe for the treatment of stroke, major depression and chronic neuropathic pain.
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 mid-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 US.
In addition, Nexstim is commercialising its Navigated Brain Stimulation (NBS) system for diagnostic applications, based on the same technology. 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 Finland and Nasdaq First North Sweden. For more information please visit www.nexstim.com.
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