Cerbomed is a privately-held medical device company based in Erlangen, Germany. Founded in 2005, the Company develops proprietary, transcutaneous neurostimulation technology (t-VNS®) to treat drug resistant epilepsy (DRE) and chronic migraine (CM). Supported by promising data, cerbomed expects t-VNS® to become a cost-efficient and safe treatment alternative to invasive vagus nerve stimulation (VNS), or other means used to treat DRE and CM patients. The transcutaneous vagus nerve stimulation (t-VNS®) is based on the established therapy of invasive vagus nerve stimulation (VNS). This invasive therapy has been established for 15 years in the US by Cyberonics, Inc. and requires a surgical intervention to place a pacemaker-like stimulation device into the chest and to connect an electrode mechanically with the cervical branch of the vagus nerve in the neck of the patient. In 1997 this invasive device was FDA cleared for the treatment of depression and epilepsy and has already been used about 100,000 times (95% epilepsy treatment).Cerbomed’s device NEMOS® for transcutaneous vagus nerve stimulation uses the auricular branch of the vagus nerve that is located closely under the skin in a defined area of the outer ear (cymba conchae). This branch of the vagus nerve can be assessed by electrical stimulation through the skin (“transcutaneously”). With its product NEMOS®, Cerbomed has developed and patented a stimulation device and a dedicated ear electrode. Cerbomed was able to provide results of pre-clinical and clinical research to proof the mechanisms and physiological background of t-VNS®. Results of initial clinical trials are supporting the basic assumptions and provide clear hints of therapeutic effects. A randomized controlled trial (RCT) in epilepsy (DRE) is currently conducted at 10 university centers in Germany and Austria. A RCT on chronic migraine (CM) is conducted at the University Hospital in Munich, Germany.t-VNS® is a new and innovative option for patients suffering from difficult-to-treat epilepsies, depression or migraine. Compared to other therapy options – pharmacological or surgical – t-VNS® has significantly lower risks and side effects. The t-VNS® device NEMOS® is used and directly controlled by the patient and can easily be integrated into the daily life. A compliance control functionality is able to record usage and quality of the therapy.With NEMOS® cerbomed has developed a novel, proprietary, patient-controlled, non-invasive device for transcutaneous vagus nerve stimulation (t-VNS®). NEMOS® transcutaneously stimulates the vagus nerve by means of electrodes inside of an earpiece positioned in the outer ear (cymba conchae). The product is intended to be carried by the patient 3 times a day for about 1.5 hours per session in a manner similar to a mobile phone or a music player with cable connected earpiece. Cerbomed’s t-VNS® device has European marketing clearance (CE-mark) for the treatment of epilepsy, depression and pain.NEMOS® is used within the EpimiRNA framework as easy-to-use and low side effect stimulation device for nerumodulation in WP3.

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