Helsinki, 16 December 2014 at 1:00 pm
* Trial using Nexstim's Navigated Brain Therapy (NBT®) system for pain relief
in patients suffering from chronic neuropathic pain
* Second study using Nexstim's technology at The Walton Centre, the only
specialist neuroscience centre in the NHS, to show long term effect of NBT®
in chronic pain
* Previous study demonstrated 44% of patients obtained clinically meaningful
pain relief of at least 3 weeks' duration
* Potential new indication for Nexstim proprietary 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 a co-operation agreement with The Walton Centre,
Neuroscience Research Centre, NHS Foundation Trust, UK, to develop the use of
Nexstim's Navigated Brain Therapy (NBT®) system for the relief of chronic pain.
An investigator-led 2-year trial will commence in January 2015 to look at the
long-term efficacy of maintenance treatment for neuropathic pain with NBT®. The
Walton Centre, a world-renowned expert in the field of neuropathic pain
research, will act as a reference site for Nexstim in the treatment of chronic
pain. Neuropathic pain is a major public health problem globally due both to
its prevalence, affecting up to 6-7% of the general population[i], and the
limited efficacy of current therapies, where 30-40% of patients declare they
only receive satisfactory (>50%) relief from their chronic pain through
pharmacological treatment[ii].
Professor Turo Nurmikko, Professor in Pain Relief at The Walton Centre's
Neuroscience Research Centre, and his team, have already completed a clinical
trial, including a control group, utilising Nexstim's navigated technology for
treatment of chronic neuropathic pain. In this 39 patient trial, Nexstim's
electric field based Transcranial Magnetic Stimulation (TMS) navigation was
found to be essential for localisation of optimal cortical targets for therapy
delivery, with 44% of patients obtaining clinically meaningful pain relief of at
least 3 weeks' duration versus 4%, whose pain was refractory to conventional
therapy, when the control site was stimulated. This trial will now be followed
up with a study aimed at establishing the long-term efficacy of maintenance
therapy over a two year period in at least 15 patients. Data from this study is
expected to be published in a peer review journal in due course.
Neuropathic pain is a complex chronic pain caused by a primary lesion or
dysfunction in the nervous system which, using current therapeutic options, the
pharmaceutical industry has struggled to improve. It is estimated that only one
in four patients with neuropathic pain experience over 50% pain relief. The
market for neuropathic pain is expected to grow from US$2.4 billion in 2010 to
reach $3.6 billion by 2020 [iii].
Nexstim intends to obtain a CE mark for use of its NBT® device in treatment of
chronic neuropathic pain and to add chronic neuropathic pain to its indication
pipeline.
Janne Huhtala, Chief Executive Officer of Nexstim, commented: "This second trial
using our NBT® device for the treatment of chronic neuropathic pain demonstrates
the significant breadth of specialist applications our technology can
potentially be used for. Our work with The Walton Centre, the only specialist
neuroscience centre in the NHS, presents an exciting opportunity to contribute
to the commercial development of our technology and the route to potentially
finding an improved treatment for chronic pain.
"In line with our strategy outlined at the time of our recent IPO we are now
successfully delivering on the expansion for NBT® into new strategic markets.
Meanwhile our Phase III multi-centre trial for NBT® in stroke rehabilitation
continues successfully in the US."
Professor Turo Nurmikko, Professor in Pain Relief at The Walton Centre, added:
"Nexstim's NBT® technology has demonstrated its efficacy in pain relief which we
look forward to trialling further over the next two years. By effectively
localising and treating cortical targets with this system we can make
significant inroads into providing a solution to this debilitating neuropathic
pain condition that is well tolerated and accepted by patients, adding to its
potential for future clinical use."
Financial impact
Nexstim estimates that this agreement will not have a significant direct
financial impact on the company for the years 2014-2017. The company estimates
that chronic pain, as a new use of Nexstim's NBT® system, can grow market
potential from 2017 onwards.
NEXSTIM PLC
Janne Huhtala, Chief Executive Officer
For further information please visit www.nexstim.com or contact:
Nexstim +358 40 8615046
Janne Huhtala, Chief Executive Officer janne.huhtala@nexstim.com
UB Capital Oy (Certified Adviser) +358 9 2538 0225
Consilium Strategic Communications +44 (0)20 3709 5700
Mary-Jane Elliott nexstim@consilium-comms.com
Amber Bielecka
Ivar Milligan
Laura Thornton
About Nexstim Plc
Nexstim, formed in 2000 and based in Finland, 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 visit www.nexstim.com.
About Transcranial Magnetic Stimulation (TMS) and Repetitive Transcranial
Magnetic Stimulation (rTMS)
Transcranial Magnetic Stimulation (TMS) is a noninvasive technique that consists
of a magnetic field emanating from a wire coil held outside of the head. The
magnetic field induces an electrical current in nearby regions of the brain.
Repetitive Transcranial Magnetic Stimulation (rTMS) sends repetitive and focused
stimulation to one region of the brain. rTMS is not used for motor mapping, it
is used for FDA cleared speech and language mapping (NexSpeech®) and in clinical
trials for therapies such as stroke and depression.
About Navigated Brain Stimulation (NBS)
Navigated Brain Stimulation NBS is a non-invasive procedure providing an
accurate and detailed map of the critical functions of the cortex. Through the
use of a standard MRI brain scan, transcranial magnetic stimulation, and EMG,
this procedure excites and records responses of precise areas of the cortex for
use in diagnostic applications.
About Navigated Brain Therapy (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.
Please note: Nexstim`s NBS System is cleared by the FDA for assessment of the
motor and speech cortices for pre-procedural planning. The NBT® System is not
cleared for commercial distribution in the United States.
About The Walton Centre, NHS Foundation Trust
The Walton Centre is the only specialist neurosciences NHS Trust in the UK. Its
specialist staff offer a world class service in diagnosing and treating injuries
and illnesses affecting the brain, spine and peripheral nerves and muscles; and
in helping people suffering from long term neurological conditions.
About Chronic Neuropathic Pain
Neuropathic pain is a chronic pain condition caused by a primary lesion or
dysfunction in the nervous system. It can be a consequence of many different
insults, such as trauma, neuronal injury or infection. Neuropathic chronic pain
is estimated to affect over 6 million people across the seven major
pharmaceutical markets (USA, Japan, France, Germany, Italy, Spain and the United
Kingdom) in 2010, and the market for neuropathic pain is expected to grow from
US$2.4 billion in 2010 to reach $3.6 billion by 2020. It is estimated that only
one in four patients with neuropathic pain experience over 50% pain relief. The
pharmaceutical industry has so far struggled to improve on current therapeutic
options, owing to the complexity of identifying the most appropriate targets to
investigate. Current significant side effects such as drowsiness, dizziness and
somnolence, which negatively affect patients' quality of life [iii].
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[i]Bennett, M.I., Smith, B.H., Torrance, N. And Lee, A.J. 2006: Can pain be more
or less neuropathic? Comparison of sumptom assessment tools with ratings of
certainty by clinicians. Pain 122, 289-94.; Bouhassira, D., Lanteri-Minet, M.,
Attal, N., Laurent, B. And Touboul, C. 2008: Prevalence of chronic pain with
neuropathic characteristics in the general population. Pain 136, 380-7.
[ii]Attal, N., Cruccu, G., Haanpää, M., Hansson, P., Jensen, T.S., et al. 2006:
EFNS guidelines on pharmalogical treatment of neuropathic pain. Eur J Neurol
13: 1153-1169.
[iii] Nightingale, S. 2012: The neuropathic pain market. Nature Reviews Drug
Discovery 11, 101-102
[HUG#1880536]
Nexstim adds Chronic Neuropathic Pain Therapy to its clinical indication pipeline with co-operation agreement with the Walton Center
| Source: Nexstim Oyj