Nexstim Announces The Start Of Patient Enrolment In The Supplementary Phase III Trial In Stroke Rehabilitation With Its NBT System
Company announcement, Helsinki, 7 March 2017
Nexstim Plc (NXTMH:HEX, NXTMS:STO) ("Nexstim" or "Company"), a medical technology company with a pioneering navigated non-invasive brain stimulation system (NBT® system), announces that it has enrolled the first patients in its supplemental Ph III clinical trial in stroke rehabilitation, known as E-FIT (ELECTRIC FIELD NAVIGATED 1HZ RTMS FOR POST-STROKE MOTOR RECOVERY TRIAL) at the Rancho Los Amigos National Rehabilitation Center, Downey, California, U.S.A.
As previously announced, this clinical trial is designed to supplement the completed Ph III NICHE trial. The supplemental trial will be conducted at five clinical sites in the U.S.A. and will include a total of 60 subjects. All sites participating in E-FIT trial also participated in the completed NICHE trial. Nexstim expects that the E-FIT trial to be completed in Q1 2018 and to file for FDA clearance by end of April 2018. FDA clearance would allow Nexstim to start marketing and selling its NBT® system for stroke rehabilitation in the USA.
Commenting on the enrolment of the first subjects, Charles Y. Liu, MD, PhD, Professor of Neurological Surgery, Neurology, and Biomedical Engineering and Director, USC Neurorestoration Center, the Principal Investigator at the enrolling site, stated: “As the top enrolling site in the previous NICHE trial, we are excited to participate in the E-FIT trial. We are looking forward to the trial being completed and data analysed together with the good outcomes seen in the NICHE trial.”
Commenting on the start of this trial, Jarmo Laine, Vice President Medical Affairs, Nexstim Plc stated: “ The E-FIT trial preparations and start-up have gone extremely well. I am very pleased to report the rapid enrolment of clinical sites and our first trial subjects and we look forward to bringing the rehabilitation benefits that our NBT® system could deliver to stroke patients in the US in addition to Europe where we already have CE mark approval.”
NEXSTIM PLC
Martin Jamieson, Chairman and CEO
Further information is available on the website www.nexstim.com or by telephone:
Nexstim
+447715163942
Martin Jamieson, Chairman and CEO
martin.jamieson@nexstim.com
UB Securities Oy (Certified Adviser)
+358 (0)9 2538 0246
Citigate Dewe Rogerson
+44 (0)207 2821066
Katja Stout
katja.stout@citigatedr.co.uk
About Nexstim Plc
Nexstim is a medical technology company which has pioneered its technology in brain diagnostics with the Navigated Brain Stimulation (NBS) system. It is the first and only FDA cleared and CE marked system based on navigated Transcranial Magnetic Stimulation (nTMS) for pre-surgical mapping of the speech and motor cortices of the brain. Based on the same technology platform, the Company has developed a system called Navigated Brain Therapy (NBT®) which is CE marked for the treatment of chronic neuropathic pain, major depression and stroke. Nexstim shares are listed on the Nasdaq First North Finland and Nasdaq First North Sweden. For more information please visit www.nexstim.com
Nexstim Plc (NXTMH:HEX, NXTMS:STO) ("Nexstim" or "Company"), a medical technology company with a pioneering navigated non-invasive brain stimulation system (NBT® system), announces that it has enrolled the first patients in its supplemental Ph III clinical trial in stroke rehabilitation, known as E-FIT (ELECTRIC FIELD NAVIGATED 1HZ RTMS FOR POST-STROKE MOTOR RECOVERY TRIAL) at the Rancho Los Amigos National Rehabilitation Center, Downey, California, U.S.A.
As previously announced, this clinical trial is designed to supplement the completed Ph III NICHE trial. The supplemental trial will be conducted at five clinical sites in the U.S.A. and will include a total of 60 subjects. All sites participating in E-FIT trial also participated in the completed NICHE trial. Nexstim expects that the E-FIT trial to be completed in Q1 2018 and to file for FDA clearance by end of April 2018. FDA clearance would allow Nexstim to start marketing and selling its NBT® system for stroke rehabilitation in the USA.
Commenting on the enrolment of the first subjects, Charles Y. Liu, MD, PhD, Professor of Neurological Surgery, Neurology, and Biomedical Engineering and Director, USC Neurorestoration Center, the Principal Investigator at the enrolling site, stated: “As the top enrolling site in the previous NICHE trial, we are excited to participate in the E-FIT trial. We are looking forward to the trial being completed and data analysed together with the good outcomes seen in the NICHE trial.”
Commenting on the start of this trial, Jarmo Laine, Vice President Medical Affairs, Nexstim Plc stated: “ The E-FIT trial preparations and start-up have gone extremely well. I am very pleased to report the rapid enrolment of clinical sites and our first trial subjects and we look forward to bringing the rehabilitation benefits that our NBT® system could deliver to stroke patients in the US in addition to Europe where we already have CE mark approval.”
NEXSTIM PLC
Martin Jamieson, Chairman and CEO
Further information is available on the website www.nexstim.com or by telephone:
Nexstim
+447715163942
Martin Jamieson, Chairman and CEO
martin.jamieson@nexstim.com
UB Securities Oy (Certified Adviser)
+358 (0)9 2538 0246
Citigate Dewe Rogerson
+44 (0)207 2821066
Katja Stout
katja.stout@citigatedr.co.uk
About Nexstim Plc
Nexstim is a medical technology company which has pioneered its technology in brain diagnostics with the Navigated Brain Stimulation (NBS) system. It is the first and only FDA cleared and CE marked system based on navigated Transcranial Magnetic Stimulation (nTMS) for pre-surgical mapping of the speech and motor cortices of the brain. Based on the same technology platform, the Company has developed a system called Navigated Brain Therapy (NBT®) which is CE marked for the treatment of chronic neuropathic pain, major depression and stroke. Nexstim shares are listed on the Nasdaq First North Finland and Nasdaq First North Sweden. For more information please visit www.nexstim.com