Press release - June 7th, 2010

cerbomed reports positive intermediate results from epilepsy pilot study

Erlangen, June 07th, 2010. An evaluation has revealed positive intermediate results for the first three months of data from the clinical trials for the treatment of therapy resistant epilepsies with the world’s first device using transcutaneous vagus nerve stimulation (t-VNS), from cerbomed gmbh. t-VNS proves its good safety profile and scores high on user-friendliness, and there are also preliminary indications of its effectiveness, for the patients in the cMPsE01 pilot study.
The cMPsE01 pilot study is structured as an uncontrolled, single-centre prospective pilot study with a verum group, carried out under the supervision of Professor Dr. Hermann Stefan, at the epilepsy centre of the University Hospital of Erlangen. The study includes 10 patients, for an expected therapy period of 9 months.

The primary aim of the clinical trial is to prove the safety and feasibility, as well as the compliance of transcutaneous vagus nerve stimulation (t-VNS). The study’s secondary aim is the early determination of whether t-VNS has anticonvulsive effectiveness, that is, whether it reduces the frequency and duration of episodes in hard-to-treat epilepsies. A further goal is to gather information for planning the number of cases, as well as specific inclusion and exclusion criteria for the planned follow-up study, which will focus on the effectiveness of t-VNS therapy.

The leader of the clinical trial, Professor Dr. Stefan, explains: "The enormous need for effective alternative forms of therapy for therapy resistant epilepsies was the stimulus to start clinically testing cerbomed’s promising t-VNS technology. We are pleased the intermediate results of the clinical trial have turned out to be so positive, and that they prove the safety and feasibility of t-VNS. Also, we have seen the first indicators of the possible effectiveness of the new therapy, which uses cerbomed’s transcutaneous vagus nerve stimulator."

Dr. Andreas Hartlep, managing director of cerbomed, adds: "The intermediate results of the pilot study confirm for us that developing our innovative transcutaneous vagus nerve stimulators (t-VNS) will, in the future, provide people with hard-to-treat epilepsies with a safe and feasible treatment alternative."

Comparing t-VNS to VNS
t-VNS uses the principle of invasive vagus nerve stimulation (VNS), which has been established as a method to treat therapy resistant epilepsy, and is certified for use in North American and European markets. Until now, the only available product for VNS that is reimbursed by health insurance organisations is a device which must be surgically implanted in the patient’s neck, in the immediate vicinity of the vagus nerve. Taken together, the product and medical costs of invasive vagus nerve stimulation, are approximately US$33,000 in the USA.

cerbomed gmbh developed a patented technology that aims to make the transcutaneous application of VNS possible. This removes the need for an operation, thus eliminating the associated risks, costs and side effects. This means a considerably more patient friendly and economical treatment. cerbomed’s technology uses the fact that branches of the vagus nerve run immediately under the surface of the skin close to the ear, and are therefore suitable for stimulation through the skin.

The market potential of therapy resistant epilepsies Epilepsy is an illness with various expressions that affects roughly 1% of the population. Within the group of epileptic illnesses there are different types of episode, but with a common cause in a brain malfunction. Only around 70% of patients suffering from epilepsy can gain sufficient control over their illness using medicine. The remaining 30% – or 1.2 million people in North America and Europe – are regarded as hard-to-treat or therapy resistant, and rely on alternative therapies, like neurosurgical intervention or invasive vagus nerve stimulation.
This shows the enormous market potential of t-VNS for patients, who could profit from an alternative therapy that offers them a high clinical effectiveness and an improved quality of life.

Milestones 2010
cerbomed gmbh has already reached several decisive milestones in its 2010 business year. In March, the transcutaneous vagus nerve stimulator got the CE label for use for the indications of depression and epilepsy, and can therefore be marketed and sold in the European Union. In addition, another 3 clinical trials began for the indications of pain, schizophrenia and tinnitus at renowned university hospitals, backing up promising expert discussions with scientific evidence into the use of t-VNS therapy.

About cerbomed:
cerbomed is a young, medical device company focusing on the research, development and manufacturing of innovative technologies and products in the area of neurostimulation. Its major proprietary procedure, transcutaneous vagus nerve stimulation (t-VNS), will offer a new, alternative treatment for various neuropsychiatric disorders with clinical benefit and improved quality of life at a superior cost benefit ratio.
Since its foundation in December 2005, cerbomed has received many innovation and new enterprise prices (including university- and chamber of commerce new enterprise awards), and was among the federal winners of the German new enterprise prize in 2006.

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