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Nexstim adds Chronic Neuropathic Pain Therapy to its clinical indication pipeline with co-operation agreement with the Walton Center

16 December 2014

  • 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 populationi, 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 treatmentii.

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 2020iii.

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
Janne Huhtala, Chief Executive Officer
+358 40 8615046

UB Capital Oy (Certified Adviser)
+358 9 2538 0225

Consilium Strategic Communications
Mary-Jane Elliott, Amber Bielecka, Ivar Milligan, Laura Thornton
+44 (0)20 3709 5700
nexstim@consilium-comms.com 

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.

[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

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