Company announcement, Helsinki, 19 May 2017 at 9:00 am
Nexstim Plc (NXTMH:HEX, NXTMS:STO) (“Nexstim” or “Company“), a medical technology company developing and marketing pioneering navigated non-invasive brain stimulation systems for both therapeutic and diagnostic applications, today provided a timeline update for its supplemental Phase III clinical trial in stroke rehabilitation, known as E-FIT (ELECTRIC FIELD NAVIGATED 1HZ RTMS FOR POST-STROKE MOTOR RECOVERY TRIAL).
The trial began enrolment in March of 2017. Start-up issues at some of the enrolling sites have created a slight delay in the enrolment rate and Nexstim now expects the E-FIT trial to be completed in Q2 2018. This change in timing has no significant impact on the costs associated with the E-FIT trial. We are now encouraged by the recent rate of patient enrolment.
The E-FIT clinical trial, which is evaluating Nexstim’s NBT® system, is designed to provide data to supplement the completed Phase III NICHE trial. The supplemental trial is being conducted at five clinical sites in the U.S.A. and is expected to recruit a total of 60 subjects.
Martin Jamieson, Chairman and CEO
Further information is available on the website www.nexstim.com or by telephone:
Martin Jamieson, Chairman and CEO firstname.lastname@example.org
UB Securities Oy (Certified Adviser) +358 (0)9 2538 0246
Citigate Dewe Rogerson +44 (0)207 2821066
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