The NBT® system is currently in a 60 patient, supplemental Phase III study, E-FIT trial, for its use in stroke rehabilitation for hand and arm movement in the US. The trial is expected to complete in mid-2018, following which Nexstim will file for FDA clearance. FDA clearance would allow Nexstim to start marketing and selling its NBT® system for stroke rehabilitation in the US.
Nexstim’s NBT® system is cleared by the FDA for marketing and commercial distribution for the treatment of Major Depressive Disorder (MDD) and commercialisation efforts are now underway in the US. It is CE marked in Europe for the treatment of stroke, major depression and chronic neuropathic pain.
Nexstim’s world-leading SmartFocusTM TMS technology is completely unique and allows for highly accurate targeting of stimulation through its 3D navigation system, personalised based on a patient’s MRI scan. When used in therapy, the TMS (transcranial magnetic stimulation) dose is personalised and all information on dose and navigation is stored, allowing for treatments to be repeated with guaranteed precision at the correct location.
Nexstim continues to invest in sales, marketing and clinical resources in line with its growth strategy to validate and commercialise its NBT® system. Nexstim is supported by an experienced management team driving its growth strategy and remains well funded to deliver key milestones.
Nexstim shares are listed on both Nasdaq First North Finland and Nasdaq First North Sweden following an IPO in November 2014.