NBT® system is the only FDA approved personalised navigation approach for accurate targeted brain stimulation in therapy
Helsinki – Nexstim Plc (NXTMH:HEX, NXTMS:STO) ("Nexstim" or "Company"), the targeted neuromodulation company developing and marketing pioneering navigated non-invasive brain stimulation systems for both therapeutic and diagnostic application, announces that it is launching its Navigated Brain Therapy (NBT®) system in the US for the treatment of Major Depressive Disorder (MDD) at the Clinical TMS (transcranial magnetic stimulation) Society Annual Meeting in New York following FDA clearance for the device in November last year.
The Clinical TMS Society Annual Meeting takes place from 11-13 May, and is a focused conference, bringing together over 500 participants including current and new TMS practitioners. Nexstim will introduce and demonstrate the use of its NBT® system at the event and will also participate in a PULSES workshop session to train physicians in the use of the system to treat depression.
The system has been cleared by the FDA for the treatment of MDD, 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 SmartFocusTM TMS technology.
To drive the uptake of its highly differentiated system, Nexstim is expanding its US based field organization to support sales and service, led by Steve Beller, Vice President and General Manager, North America. The Company will also establish a US TMS Therapy Clinical Advisory Panel comprising physicians who adopt the NBT® system, to provide advice and feedback on use of the system, including potential new therapeutic applications.
Martin Jamieson, Chairman and CEO, Nexstim Plc commented:“We are extremely pleased to announce the launch of our NBT® system for depression at this TMS focused event. The unique navigational capability of our system, personalised to each patient for targeted stimulation of the relevant brain area, clearly differentiates it from the non-navigational TMS devices currently on the market for this indication.”
Nexstim also attended the American Psychiatry Association Annual Meeting which took place from 5-8 May and had over 13,000 attendees, largely psychiatrists, where it promoted its NBT® system for use in depression.
Martin Jamieson, Chairman and CEO
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Martin Jamieson, Chairman and CEO
Citigate Dewe Rogerson
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David Dible/Shabnam Bashir/Isabelle Andrews
About Navigated Brain Therapy (NBT®) in depression
The NBT® system is based on Nexstim’s unique SmartFocusTM TMS (transcranial magnetic stimulation) technology, differentiated from other TMS systems through its navigational capabilities, allowing for personalised, accurate and reproducible stimulation of the specific area of the brain associated with depression. This is achieved through its 3D navigation system, personalised based on a patient’s MRI scan.
In depression, metabolic activity of the left dorsolateral prefrontal cortex (DLPFC) is reduced.
Stimulation by high frequency repetitive TMS increases activity of DLPFC. Without navigation, the DLPFC is anatomically optimally targeted in just 30% of patients, as it is located via a skull landmark exercise, through measuring 5 cm from the motor cortex on the patient’s head. Navigation using Nexstim’s 3D brain reconstruction and accurate stimulation through the e-field allows for reproducible targeting, an average distance difference for hotspot of stimulation of 2.3 cm vs the conventional 5 cm method (Ahdab et al, 2010).
About Nexstim Plc
Nexstim is a targeted neuromodulation 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 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 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.