patients and family NEMOS for treatment of epilepsies

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1 patients and family NEMOS for treatment of epilepsies

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3 Transcutaneous Vagus Nerve Stimulation (t-vns ) with NEMOS a promising treatment option No surgery No hospitalisation Minor side effects Self-administered as part of your daily routine Test period of 6 months

4 What is epilepsy? For a healthy person, the exchange of electrical and chemical signals between nerve cells in the brain is precisely co-ordinated. For patients who suffer from epilepsy, this co-ordination can be temporarily disturbed, resulting in pathological electrical discharges. As a result, nerve cells then respond by sending sudden, uncontrolled signals, creating an electrical storm in the brain. This spreads and activates individual brain areas or even the whole brain in an unnatural way. The symptoms and expressions of the resulting epileptic seizure depend on the areas affected. THERAPY More than 30 percent of patients with epilepsy suffer from regular seizures, despite appropriate treatment with anti-convulsive drugs. Few treatment options are currently available for these patients. These involve epilepsy surgery, deep brain stimulation and invasive vagus nerve stimulation.

5 Transcutaneous Vagus Nerve Stimulation a promising therapy option THERAPY OPTION t-vns Transcutaneous Vagus Nerve Stimulation (t-vns ) uses the fact that a branch of the vagus nerve can be stimulated through the skin (transcutaneous) with electrical impulses, in areas of the outer ear. The vagus nerve is involved in the regulation of nearly all inner organs. Above all, it affects those areas of the brain which play a role in the onset, the course and the therapy of various neurological and psychiatric disorders. The stimulation of the vagus nerve passes along particular nerve fibres to reach the brainstem. As with invasive vagus nerve stimulation, this activates higher centres of the brain associated with an anti-convulsive (anti-seizure) effect (Fig. 1). This stimulation is carried out with the transcutaneous vagus nerve stimulator NEMOS. Fig. 1: Stimulus transmission via vagus nerve from the ear to the brain Site of stimulation Transmission of the excitation and activation of the brain Brainstem Auricular branch of the vagus nerve

6 NEMOS the transcutaneous vagus nerve stimulator PRINCIPLE OF OPERATION The transcutaneous vagus nerve stimulator NEMOS (pictured above) consists of a stimulation unit and a dedicated ear electrode. The stimulation unit, which is approximately the size of a mobile phone, sends out electrical impulses. It is connected with the ear electrode, which patients wear like an earphone (see diagram). The impulses are transferred via the ear electrode through the skin to a branch of the vagus nerve.

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8 NEMOS more autonomy in everyday life APPLICATION The treatment with NEMOS is carried out by patients themselves in sessions lasting at least an hour, 3 or 4 times a day, for a total of 4 to 5 hours per day. You can regulate and adapt the intensity of the stimulation according to your individual sensitivity, which can vary from day to day or even over the period of the therapy. It is important that the stimulation is noticeable, as a tingling sensation at the stimulation site. Using NEMOS does not involve surgery, or hospitalisation. You can carry on with your usual everyday activities during the stimulation session, so NEMOS is easy to integrate into your daily routine.

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11 NEMOS the patient-friendly therapy EFFICACY Most treatment options for epilepsies, such as pharmaceuticals, deep brain stimulation and invasive vagus nerve stimulation, are not acute treatments. This also applies for NEMOS. It may take several weeks or even months for patients to experience noticeable benefit from NEMOS therapy. As with all other therapies there can never be a guarantee of success for a treatment using NEMOS and some patients may not respond sufficiently to the therapy. Such patients can return the device after 6 months, for a partial refund of the purchase price. SIDE EFFECTS t-vns is a therapeutic alternative with minor side effects. An analysis of data from over 800 patients and volunteers, who participated in studies of t-vns, showed potential side effects that include itching, discomfort in the area of the outer ear and local pain at the stimulation side. These side effects usually disappear soon after stopping the stimulation. * * Vigilance data cerbomed GmbH

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13 Why NEMOS? No surgical intervention t-vns -therapy with NEMOS provides targeted stimulation of the vagus nerve, without the risks of a surgical intervention. Minor side effects t-vns is a therapeutic alternative with minor side effects. Potential side effects usually disappear soon after stopping the stimulation. * Easy to use You can treat yourself with t-vns in a familiar environment. There is no need for surgery or an inpatient stay. The menu-driven operation of the device is so simple that NEMOS can easily be integrated into your daily routine. Test period of 6 months If patients do not respond sufficiently to the therapy, they can return the device after 6 months for a partial refund of the purchase price. * Vigilance data cerbomed GmbH

14 Frequently asked questions Am I suitable for t-vns therapy with NEMOS? We developed the NEMOS therapy for patients who suffer from epilepsies. You decide together with your doctor whether this therapy is suitable for you. The NEMOS device is not certified for treating patients during pregnancy, or for patients with active implants (such as a cardiac pacemaker, or a cochlear implant).

15 ???????! How can I order NEMOS? If you decide, with your doctor, to use the NEMOS therapy, please get in touch with us. Further information is available on How much does NEMOS cost? Information on the price and financing options are available on request. Can I stop using medications if I decide to use t-vns? t-vns is a complementary therapy to medical treatment. Only your doctor can decide whether you can stop or reduce medications. How often do I have to use NEMOS? The treatment with NEMOS is carried out by the patient in sessions lasting at least an hour, 3 or 4 times a day, for a total of 4 to 5 hours per day. How long does it take until the effect of t-vns occurs? Most treatment options for epilepsies, like pharmaceuticals, deep brain stimulation and invasive vagus nerve stimulation, are not acute treatments. This also applies to NEMOS. It may take several weeks or even months for patients to experience noticeable benefit from NEMOS therapy.

16 How long do I have to use t-vns? Like most pharmaceutical and neuromodulatory treatments for epilepsies, t-vns is a long-term therapy. Always use t-vns in consultation with your doctor. What can I do if I don t respond to t-vns? If patients do not respond sufficiently to the therapy, they can return the device after 6 months for a partial refund of the purchase price. When must NEMOS not be used? The NEMOS device is not certified for treating patients during pregnancy, or for patients with active implants (such as a cardiac pacemaker, or a cochlear implant). The device must not be used on wounds and diseased skin in the area of the electrodes. For further information about the therapy with NEMOS please contact us: sales@deltasurgical.co.uk - or NEMOS is distributed in the UK by: Delta Surgical Ltd Unit Brockway Newcastle under Lyme ST5 6AZ sales@deltasurgical.co.uk

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18 This brochure is for information only. It does not substitute the instructions and explanations of a physician. Please contact your doctor concerning questions with medical relevance or health issues. Please note that NEMOS is approved for the European market only. NEMOS is not cleared or approved for use in the U.S. cerbomed GmbH. All rights reserved.

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20 V201501EP_UK Further information is available on Manufacturer: cerbomed GmbH Henkestraße Erlangen Germany Distributor in the UK: Delta Surgical Ltd Unit Brockway Newcastle under Lyme ST5 6AZ