Press release - June 21st, 2012

Cerbomed GmbH: Start of a multi-center trial into t-VNS for drug-resistant epilepsy

ERLANGEN/KEHL-KORK, June 21st, 2012
The medical device company cerbomed GmbH, Erlangen, Germany and the Epilepsy Center Kork, Germany announce the inclusion of the first patient in a multi-center clinical trial into the treatment of drug-resistant epilepsy using transcutaneous Vagus Nerve Stimulation (t-VNS).

This clinical trial, conducted in seven epilepsy centers in Germany and Austria, examines the effectiveness of t-VNS in treating drug-resistant epilepsy. The trial starts with the inclusion of the first patient in Kehl-Kork, Germany, under the supervision of Prof. Dr. med. Bernhard Steinhoff and senior physician Dr. med. Barbara Hillenbrand.

Diagnosis: drug-resistant epilepsy
Drug-resistant epilepsy is characterized by continued occurrence of seizures, despite appropriate treatment with anticonvulsive drugs.

"More than 30 % of all patients with epilepsy are affected by it. These patients suffer enormously. There are only a few alternative therapeutic possibilities for this patient group at the moment", says Prof. Dr. Steinhoff, Medical Director and Senior Consultant at the Clinic and Outpatient Department for Adults at the Epilepsy Center Kork.

As a rule, these alternative methods imply hospital admission and a surgical intervention. They entail not only the risks associated with the operation, but also frequently involve undesirable effects.

"t-VNS is applied by the patient independently, as part of the daily routine. Neither a surgical intervention nor a hospital stay is necessary. Moreover, the therapy is only associated with minor side effects, which makes t-VNS a gentle and patient-friendly therapeutic option", explains Prof. Dr. med. Jens Ellrich, Chief Medical Officer of cerbomed GmbH.

Anticonvulsive effects of t-VNS
In a case series, carried out with the Epilepsy Center Erlangen on seven patients who had suffered from drug-resistant epilepsy for many years, t-VNS could already be shown to be a safe and tolerable method for long-term application. Five of the seven patients who applied t-VNS for nine months showed a reduction in seizure frequency. Prof. Dr. Ellrich: "Based on the results of this pilot study we have decided to carry out a multi-center trial for the therapy of drug-resistant epilepsy. This should confirm t-VNS as a safe and effective therapeutic option."

About t-VNS
Transcutaneous Vagus Nerve Stimulation is addressed to patients suffering from various difficult to treat neurological and psychiatric diseases. The t-VNS therapy uses the fact that a branch of the vagus nerve is located directly under the skin in areas of the outer ear and therefore can be stimulated through the skin (transcutaneously) with electrical impulses.

t-VNS with NEMOS
For t-VNS cerbomed developed and patented a special stimulator and a dedicated ear electrode. The stimulator, which is connected with the ear electrode, sends out the electrical impulses. With the transcutaneous vagus nerve stimulator NEMOS a targeted stimulation of the vagus nerve gets possible without the need of a surgery.

The German market entry for NEMOS is planned for the third quarter of 2012. NEMOS will then be available for patients suffering from difficult-to-treat epilepsies and depression.

About cerbomed
Cerbomed GmbH is an innovative medical device company that concentrates on researching, developing and producing new technologies and products for neuromodulation. The company’s focus is on transcutaneous Vagus Nerve Stimulation (t-VNS), which may offer an attractive therapy option for patients with hard-to-treat neurological and psychiatric illnesses.

In 2011 cerbomed received the European clearance (CE mark) for the transcutaneous vagus nerve stimulator NEMOS. At the moment, two clinical trials are being conducted regarding the effectiveness of t-VNS in patients with drug-resistant epilepsy and chronic migraine.

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Please note: NEMOS® is not cleared or approved for use in the U.S.