10-04-2019Danish breakthrough in treatment of epilepsy

Danish breakthrough in treatment of epilepsy
Danish professor and Dr. Med. Henning Beck-Nielsen has invented an implant that will help epilepsy patients avoid feared epileptic seizures – and may also help save lives. The implant has just gained CE approval.

People with epilepsy often go through life uncertain when and how badly they will suffer dreaded epileptic seizures. At the same time, the risk of premature death is higher in people with epilepsy than in the general population. Danish company UNEEG medical decided to change that, and they have reached the first important goal: led by Professor Henning Beck-Nielsen, Dr. Med and co-founder Rasmus Stig Jensen MSc (Eng), the company has just obtained approval for a technology—UNEEG 24/7—enabling medical professionals to measure brain activity over many months and thus obtain accurate information on what is happening. The patient avoids spending a week in hospital, and the likelihood of recording all seizures increases significantly. Doctors thus gain a solid foundation for optimizing the use of medicine, hence improving the patient’s quality of life and potentially avoiding seizures altogether.

‘The initial target group is the 30% of patients who are most affected by epilepsy and who are not responding sufficiently to conventional medical treatment. As 1% of the world’s population suffer from epilepsy—over 500,000 of them in the UK and more than five million in Europe—UNEEG medical is entering a challenging area’, says CEO Torben Sandgren.

First clinical trials completed
Brain researcher Troels W. Kjær, a consultant at the Neurophysiological Department at Roskilde Hospital and professor at the University of Copenhagen, has completed the first major clinical trial on patients with UNEEG medical’s EEG device, and sees great potential: ‘This will bring about major changes for both patients and the economy’, predicts Prof. Kjær, pointing out that the largest improvement will be for those patients where monitoring of EEG will enable optimization of the choice and use of medicine and potentially prevent seizures altogether within six months.

Troels W. Kjær stresses that the measurements will not guarantee everyone a seizure-free life, but will contribute to medicine optimization, leading to a better life for practically all patients.

The only device on the market for ultra-long-term monitoring of EEG
‘Lack of knowledge about the patient’s brain activity has often made it difficult to optimize and adjust medicine use in the treatment of epilepsy, but it has become possible with this new system’, says Torben Sandgren.

The invention is the first of its kind in the world and consists of two elements: a discreet implant, inserted under the skin behind the patient’s ear, and a wireless mobile EEG recorder which constantly monitors the brain’s electrical activity, thus recording epileptic seizures.

Everything is supported by an app and advanced software. The implant is powered by induction and can therefore remain under the skin, as no battery is necessary. The implant is inserted during a 15-minute outpatient operation and causes no serious side effects to the patient.

The implant has so far been approved for adults, but the company aims to have it approved for children, too.

‘The primary target group for the technology consists of people with temporal lobe epilepsy, or secondarily generalized epilepsy, where there is a suspicion of suboptimal treatment. Other diagnoses may become relevant when we learn more about this new treatment method’, says Henning Beck-Nielsen.

International interest
The technology has already sparked interest internationally, and several research centres are now planning comprehensive clinical trials. One of the world’s leading centres for the treatment of epilepsy has become the first to purchase the device, which will be implanted in patients in the spring of 2019.

Interest is also high in the USA, aided by the fact that, in 2017, the technology won the US Epilepsy Foundation’s prestigious Shark Tank Prize, which is awarded for the best innovative measure to improve the treatment and care of epilepsy patients.

Danish development team behind the invention
CEO Torben Sandgren explains that a group of Danish development engineers and clinical experts, led by Rasmus Stig Jensen and CTO Richard Tøpholm, have worked for several years to develop the technology. The system is partly based on the technology—and not least the know-how—of the well-known Danish hearing aid company Widex. ‘Our focus is now on launching the product in our target markets and at the same time continuing development of the technology. One upcoming feature will be a seizure alarm that will send alerts to the patient’s relatives in the event of a potentially life-threatening seizure’, says Richard Tøpholm.

UNEEG medical now plans to establish UNEEG 24/7 in European markets, and the ambition is to have 5,000 users within three years.