Press release, Helsinki, finland 19 may 2017 there is a 9.00
Nexstim Plc (NXTMH:HEX, NXTMS:STO) (“Nexstim” or the “company”), which is a med-tech companies with a groundbreaking system for non-invasive brain stimulation in therapeutic and diagnostic applications, has today updated the time frame for the additional Phase III trial for stroke rehabilitation, known as E-FIT (ELECTRIC FIELD NAVIGATED 1HZ RTMS FOR POST-STROKE MOTOR RECOVERY TRIAL).
Recruitment of subjects started in march 2017. Due to startup problems on the part of the rekryteringsställena has recruitment been delayed slightly, and Nexstim now expects that the E-FIT-the examination will be completed during the second quarter of 2018. The revision of the time-frame has no significant effect on the cost of E-FIT-trial. The current recruitment rate is encouraging.
The trial with E-FIT is about an evaluation of the Nexstims the NBT®system and to provide additional data to the completed Phase III trial with the NICHE. The supplementary examination to be conducted on the five rehabiliteringscentraler in the united states and shall include a total of 60 subjects.
NEXSTIM PLC
Martin Jamieson, chairman of the board and ceo
Additional information is available on the website
www.nexstim.com
or per telephone:
Nexstim +44 771 516 39 42
Martin Jamieson, chairman of the board and ceo martin.jamieson@nexstim.com
UB Securities Oy (Certified Adviser) +358 (0)9 2538 02 46
Citigate Dewe Rogerson +44 (0)207 2821066
Katja Stout katja.stout@citigatedr.co.uk
About Nexstim Plc
Nexstim is a medical device company that developed and markets a ground-breaking system to navigate a non-invasive brain stimulation for therapeutic applications (NBT®system) and diagnostic applications (NBS-system). Nexstims NBS system is the first and only FDA-approved and CE-marked system to navigate transcranial magnetic stimulation (navigated Transcranial Magnetic Stimulation, nTMS) for mapping of the areas of motor skills and speech in the brain before a surgical procedure.
On the same technology platform the company has developed a system to navigate hjärnterapi (Navigated Brain Therapy, NBT®), which has received CE marking for the treatment of stroke, severe depression and chronic neuropathic pain. The NBT®system is currently undergoing additional Phase III trials (E-FIT) with 60 patients. Nexstim expects that the trial will be completed during the second quarter of 2018 and that the company then can request for authorization from the FDA. With the approval from the FDA would Nexstim able to begin marketing and selling the NBT®system for the treatment of stroke in the united states.
Nexstims shares are listed on Nasdaq First North Finland and Nasdaq First North Sweden. More information is available at www.nexstim.com.
Nexstim Plc revises the time frame for the additional Phase III trials