E-FIT trial patient enrollment06.01.2018 10:00:00 CET
Company announcement, Helsinki, 6 January 2018 at 11.00
Nexstim enrols last patient in supplementary Phase III E-FIT trial
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, announces that it has successfully completed enrolment in its supplementary Phase III clinical trial, known as E-FIT (ELECTRIC FIELD NAVIGATED 1HZ RTMS FOR POST-STROKE MOTOR RECOVERY TRIAL), evaluating the use of Nexstim's NBTŪ system in upper extremity motor rehabilitation following stroke.
The supplemental trial is being conducted at five leading clinical centres in the US and has recruited its planned total of 60 patients. The E-FIT trial uses a new sham comparator and has been designed to provide data to supplement the completed Phase III NICHE trial, which demonstrated excellent results in the active group, with 2/3 patients showing a clinically meaningful response. Active group data from the Phase III NICHE trial will be pooled with data from the E-FIT trial in the planned filing with the FDA.
Completion of the E-FIT trial is expected in mid-2018, following which Nexstim will file a de novo 510k with the FDA. Approval of this filing by the FDA would allow Nexstim to commercialise its' NBTŪ system for stroke rehabilitation in the US.
The NBTŪ system is based on Nexstim's unique navigated Transcranial Magnetic Stimulation (nTMS) which allows for accurate, reproducible brain stimulation in therapy.
Martin Jamieson, Chairman and CEO, Nexstim Plc commented: "We are extremely pleased to announce completed patient enrolment in our E-FIT trial, an important landmark on the way to commercialisation of NBTŪ for stroke rehabilitation in the US. With this announcement, we confirm trial completion is expected in mid-2018, following which we intend to file a de novo 510k for FDA clearance."
NEXSTIM PLC
Martin Jamieson, Chairman and CEO
Further information is available on the website www.nexstim.com or by contacting:
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 2822949
David Dible/Isabelle Andrews/Shabnam Bashir david.dible@citigatedewerogerson.com
About Nexstim Plc
Nexstim is a medical technology company developing and marketing pioneering navigated non-invasive brain stimulation systems for both therapeutic (NBTŪ 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 (NBTŪ) which is CE marked in Europe for the treatment of stroke, major depression and chronic neuropathic pain.
Nexstim has received clearance from the FDA for marketing and commercial distribution of its NBTŪ system for the treatment of Major Depressive Disorder (MDD) and looks forward to introducing the NBTŪ system for this important indication during H1 2018.
The NBTŪ 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 NBTŪ 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