Final Results from NICHE Phase III trial presented
Post# of 301275
Press release, Helsinki, 23 February 2017, at 4.30pm
Nexstim Plc (NXTMH:HEX, NXTMS:STO) ("Nexstim" or "Company"), a medical technology company with a pioneering navigated non-invasive brain stimulation system, today presented the final results of a multi-center Phase III trial in stroke rehabilitation (NICHE trial) assessing the Company's Navigated Brain Therapy system (NBT®) at the International Stroke Conference in Houston, TX. The presentation, by the trial Principal Investigator, Richard L. Harvey, MD, Rehabilitation Institute of Chicago, summarised the main safety and efficacy results of the NICHE trial, previously announced in March 2016.
The safety results were good with no serious adverse events (SAE) related to the use of Nexstim NBT® system. The primary outcome measure of significant clinical improvement of upper extremity motor function, defined as an increase of at least 5 points on the Upper Extremity Fugl-Meyer scale (UEFM) between baseline and six months after end of trial therapy, was reached by 67% of subjects in the active Nexstim NBT® trial arm and 65% in the sham NBT® trial arm. In the full trial population, the average improvement on UEFM was 8.2 points.
The secondary outcome measures including Action Research Arm Test; Wolf-Motor Function Test; Stroke Impact Scale; National Institute of Health Stroke Scale; Chedoke McMaster Stroke Assessment for Hand and Arm and the quality of life instrument ED-5Q, demonstrated a statistically significant improvement from baseline to 6 months after end of trial therapy in both trial arms (p<0.001 for each trial arm). As previously announced, the difference between trial arms was not statistically significant.
A journal article describing the full trial results is in preparation.
Commenting on the results, Jarmo Laine, Vice President Medical Affairs stated: "The efficacy results obtained in NICHE show functional improvement in both trial arms. As previously announced by Nexstim, we believe the sham trial arm was not a true sham. Nexstim has now agreed a new 60 patient supplementary clinical trial with the FDA. We remain confident, given the results from the active arm of the NICHE study, that we can provide an important improvement in treatment for post-acute stroke patients as they undergo rehabilitation from this debilitating disease."
In line with the FDA recommendation the data from the ongoing trial will be combined with data from the NICHE study in order to supplement the de novo 510(k) submission. Nexstim estimates it will receive efficacy results from the on-going 60 patient trial in Q1 2018. The combined results are then expected to be used to support a de novo 510(k) response in the summer or the fall of 2018. Clearance of this de novo 510(k) would allow Nexstim to start marketing and selling its NBT® system for stroke rehabilitation in the USA.
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
Citigate Dewe Rogerson +44 (0)207 2821066 Katja Stout nexstim@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 stroke, chronic neuropathic pain, and depression. Nexstim shares are listed on the Nasdaq First North Finland and Nasdaq First North Sweden. For more information please visit www.nexstim.com
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