Press release - July 10th, 2009
cerbomed announces the inclusion of the first patient in a clinical trial for the therapy of difficult-to-treat epilepsies using transcutaneous vagus nerve stimulation (t-VNS)
Erlangen, July 10th, 2009. After promising results in non-clinical examinations with the first device for transcutaneous vagus nerve stimulation (t-VNS), cerbomed gmbh has now started a clinical trial for the therapy of difficult-to-treat epilepsies, and today announced the inclusion of the first patient. Apart from proving safety and compatibility, the aim of this pilot study is an early determination of effectiveness.
The aim of the clinical trial is to prove transcutaneous vagus nerve stimulation (t-VNS), using the transcutaneous vagus nerve stimulator developed by cerbomed, is feasible and safe, for patients with difficult-to-treat epilepsies. In addition, this should provide early data on the anticonvulsive effectiveness, that is, the reduction in the frequency and duration of seizures. This will provide pointers for subsequent studies on the number of patients to include, as well as indicating specific inclusion and exclusion criteria. The pilot study, cMPsE01, is being carried out under the supervision of Professor Dr. Hermann Stefan at the epilepsy centre of the University Hospital, Erlangen. It is structured as an uncontrolled, single centre prospective pilot study and will include 10 patients over a treatment period of 9 months.
The leader of the clinical examination, Professor Stefan, explains: "Many patients do not respond or respond inadequately to anticonvulsive medication. Therefore, there is an enormous need for alternative types of effective therapy. Transcutaneous vagus nerve stimulation is extremely promising because it is non-invasive. Thus it avoids the risks associated with a surgery, and the side effects of invasive neurostimulation treatments, all to the good of the patients.”
Dr. Andreas Hartlep, Chief Technology Officer (CTO) of cerbomed, adds: "This pilot study represents a milestone in achieving broader research expertise about transcutaneous vagus nerve stimulation (t-VNS). With these results we will be able to drive on the further development of the product, and match it most favorable to the needs of this patient group. We will also get incisive knowledge for planning the subsequent, large-scale clinical trial."
As a rule, epilepsy affects about 0.8% of people, and is a lifelong condition. Around 30% of affected people are regarded as resistant to pharmaceutical treatments, which means medicinal therapy is ineffective or inadequate for them. Therapies such as epileptic surgical interventions or vagus nerve stimulation are possible as final options for treatment.
Invasive vagus nerve stimulation (VNS) has been established since the mid-1990s, and received approval in North America and Europe as a treatment for therapy resistant epilepsy. Until now, the only product for VNS that is available and eligible for reimbursement by health insurers is a device that must be surgically implanted in the chest. At present, in the USA, the costs for vagus nerve stimulation, including both the device and procedure costs, are around US$ 33,000 for each patient.
cerbomed gmbh is developing a technology that aims to make transcutaneous VNS possible. Surgery would then become superfluous, eliminating the associated risks, costs and side effects. This means a considerably more patient-friendly and a more economical treatment. cerbomed uses the fact that branches of the vagus nerve run just under the surface of the skin at the external auditory canal, and are therefore suitable for stimulation through the skin.
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.