Du är här


Nexstim Oyj: Notification of conference call to discuss the positive interim analysis recommendation from the Data Safety Monitoring Board on Nexstim Plc's ong

Helsinki, 28 September 2015 at 9:00 am

* Conference call to be held today at 3pm EEST / 1pm BST / 8am EDT
* Interim data analysis by an independent Data Safety Monitoring Board shows
that safety criteria are met
* Trial now further de-risked and to continue without any modifications
towards the primary endpoint of demonstrating a clinically important
functional improvement with NBT®

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 that there will be a conference call today for
analysts and investors to discuss the positive interim analysis
recommendation. The call will take place at3pm EEST / 1pm BST / 8am EDT
and will be hosted by Janne Huhtala, CEO and Mikko Karvinen, CFO. The dial in
instructions are below. A copy of the presentation will be available on the
Company's website shortly before the call. The call ID is 61745818#. A
playback can be accessed on +44 (0)20 3426 2807 with the reference 662425#.

Finland +358 (0)9 8171 0317

Sweden +46 (0)8 5059 6306

UK +44 (0)20 3139 4830

USA +1 718 873 9077

In a statement issued on Saturday 26thSeptember at 12:00 noon (EEST) Nexstim
Plc announced that it had 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 towards the goal of achieving its primary endpoint. 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

Commenting on the DSMB's positive recommendation, 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 efficacy outcome data. With
positive outcome data, Nexstim will be strongly placed 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 hitting the primary endpoint and bringing this
important product to patients and care givers in rehabilitation centres as
quickly as possible."


Janne Huhtala, CEO

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


+358 (0)40

Janne Huhtala, Chief Executive Officer

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

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:


Notification of conference call


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


Författare Hugin

Tala om vad ni tycker

Tala om vad ni tycker

Ni är just nu inne på en betaversion av nya aktiespararna. Lämna gärna feedback på vad ni tycker i formuläret nedan.