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2015-09-26

Nexstim Oyj: Data Safety Monitoring Board Recommends Continuation of Nexstim Plc's Phase III Stroke Therapy Trial

Helsinki, 26 September 2015 at 12:00 noon

* Interim data analysis by an independent Data Safety Monitoring Board shows
that safety criteria are met and trial should continue without any
modifications

Nexstim Plc (NXTMH:HEX, NXTMS:STO), a medical technology company aiming to
improve rehabilitation for stroke patients through the use of non-invasive
brain stimulation, announces today that it has received a recommendation from
the Data Safety Monitoring Board (DSMB), an independent committee of experts
monitoring the trial, to continue the Phase III stroke therapy NICHE trial,
without any modifications. The first interim analysis on the NICHE
(Navigated Inhibitory rTMS to Contralesional Hemisphere) trial using
Nexstim's Navigated Brain Therapy (NBT®) was performed after 81 patients
reached their primary safety outcome assessment, on track, at six months
post-treatment. As previously announced, the second interim analysis is
expected to occur in Q1 2016 and the study is scheduled to complete in Q3
2016 when full data will be disclosed.

Nexstim commenced the pivotal, randomised, sham-controlled, double-blinded
multi-centre Phase III study in H1 2014 to demonstrate the effects of its
NBT® system on upper limb motor rehabilitation post-stroke. The two year
study is being conducted on up to 198 patients at 12 prominent rehabilitation
sites in the USA. The primary objective of the study is to demonstrate a
difference between the active NBT® and sham groups of patients to achieve a
clinically important functional improvement from baseline to six months post
treatment. The safety data was assessed on all patients 160 recruited
to-date.

This announcement has no impact on Nexstim's financial outlook for FY 2015.
Nexstim will review the future potential financial impact on the company as
part of the planning of its commercialisation strategy.

Commenting on the DSMB's recommendation to continue the trial, Janne Huhtala,
Chief Executive Officer of Nexstim, said:
"The DSMB recommendation confirms the good safety profile of our product and
de-risks the programme heading into the pivotal outcome data. With positive
outcome data, Nexstim will be in a strong position to take a significant
market position with NBT
®
for stroke therapy. We continue the unmodified trial, as planned, with
excitement and with the aim of bringing this important product to patients
and care givers in rehabilitation centres as quickly as possible."

Commenting on the trial results to date, Dr Richard L. Harvey, Medical
Director, Center for Stroke Rehabilitation, Rehabilitation Institute of
Chicago (RIC), said:
"We are encouraged by the data generated so far from this groundbreaking study
which offers hope to stroke patients as a new and effective therapy. NBT®
offers promise as an important new therapy for stroke survivors globally and
could be a real breakthrough for the major debilitating condition that has
until now been limited by a lack of any real medical advancement."

NEXSTIM PLC

Janne Huhtala, CEO

For further information please visit
www.nexstim.comor contact:

Nexstim

+358 (0)40
8615046

Janne Huhtala, Chief Executive Officer
janne.huhtala@nexstim.com

UB Securities Ltd
(Certified Adviser)
+358 (0)9 2538 0254

Consilium Strategic Communications

+44 (0)20 3709 5700

Mary-Jane Elliott / Ivar Milligan / Laura Thornton
nexstim@consilium-comms.com

About Nexstim Plc

Nexstim is a medical technology company aiming to improve rehabilitation for
stroke patients. Nexstim has pioneered its technology in brain diagnostics
with the Navigated Brain Stimulation (NBS) system as the first and only
FDA-cleared and CE-marked navigated Transcranial Magnetic Stimulation (nTMS)
device for pre-surgical mapping of the motor and speech cortices. Based on
the same technology platform, the company has developed a device for stroke
therapy called Navigated Brain Therapy (NBT®). In H1 2014, Nexstim initiated
a two-year pivotal Phase III study at 12 sites in the US aiming to
demonstrate the effectiveness of NBT® and gain FDA clearance for
commercialisation in post-acute stroke therapy in the US. Nexstim's shares
are listed on Nasdaq First North Finland and Nasdaq First North Sweden. For
more information please visitwww.nexstim.com.

About NBT®

Navigated Brain Therapy (NBT®) is a non-invasive system that uses navigation
to accurately target therapy directly to the cortical structures believed to
be involved in brain dysfunctions. The device is CE-marked to offer patients
a personalised treatment for major depression. In addition, the system is
CE-marked for use in patients recovering from stroke as a supplement to
conventional rehabilitation.

About NICHE (Navigated Inhibitory rTMS to Contralesional Hemisphere)

The NICHE trial is a pivotal, prospective, multi-centre, randomised,
controlled, double-blinded study combining active Nexstim NBS-guided 1Hz rTMS
or sham-rTMS targeting the healthy hemisphere with standardised task-oriented
rehabilitation will be conducted in patients with post-stroke motor
impairment. The therapy will be provided for six weeks and primary outcome
assessed six months later. For more information on the trial, please visit:

https://clinicaltrials.gov/ct2/show/NCT02089464

DSMB recommends continuation of Phase III trial
http://hugin.info/138152/R/1954765/711489.pdf

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This announcement is distributed by NASDAQ OMX Corporate Solutions on behalf of NASDAQ OMX Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Nexstim Oyj via Globenewswire

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