Precisis’ EASEE Epilepsy Neurostim Earns Breakthrough Status

Heidelberg, Germany-based Precisis GmbH has earned breakthrough designation from the U.S. Food and Drug Administration (FDA) for its EASEE brain stimulator. The company aims to use minimally invasive neurostimulation methods to free epilepsy patients from seizures.
 
EASEE works via electrodes invisibly placed under the scalp—on the skull bone and outside sensitive brain tissue. The electrodes stimulate the diseased brain area, which is targeted and individually adapted.
 
Currently neurostimulation or surgical treatments for focal epilepsy patients require complex interventions. EASEE is minimally invasive and can treatment can be customized to each patient based on anatomical precision.
 
“We are very pleased with the success of the multi-center studies. One in three patients does not respond to the available drug therapy options. We are in need of new, innovative treatment options such as EASEE, which represent a real alternative for patients and only entail a low risk”, Prof. Dr. Schulze-Bonhage from the University of Freiburg, Germany, who is responsible for the clinical studies, told the press.
 
Prof. Dr. Andrew Cole, Director of the Massachusetts General Hospital (MGH) Epilepsy Service in Boston/USA, Head of the Department of Clinical Neurophysiology and Epilepsy and Professor of Neurology at Harvard Medical School, added: “The results of the clinical trials in Europe are very encouraging. A series of studies is planned to start in the U.S. in 2023 with the goal of successfully introducing the therapy to the market as soon as possible.”
 
In October Precisis also closed a 20 million Euro financing round with Cochlear Limited. Two clinical studies are currently underway in European epilepsy centers. The company expects to launch EASEE in Europe this year.
 
Following is an interview Precisis managing director Dr. Angela Liedler held with the press:
 
What was your motivation to develop EASEE?
 
“I believe that the real drive for innovation stems from some kind of emotional need within oneself. Many patients with epilepsy have a clear need: they are looking for the ultimate way out of a medical predicament. In fact, oral medication is not able to help one in three epilepsy patients. These are patients who continue to have epileptic seizures even while being treated with strong medication or they are severely troubled by pharmacological side effects. So the question arises why it is not possible to “simply” suppress the origin of the epileptic seizures with electrical impulses. Before 2015, however, no one had come up with a minimally invasive, low-risk, yet precise, bioelectronic solution for epilepsy—until we invented EASEE.”
 
Why is the FDA Breakthrough Device Designation an important milestone for EASEE?
 
“The classification as a Breakthrough Device by the FDA allows for an expedited review process for clinical studies and commercial clearance of the EASEE system. This allows us to make our product available to patients even more quickly. Another important point is the ongoing mutual exchange of ideas within the development process, which will also help us to become even better and more effective in the future.”
 
What are the short- and medium-term goals for R&D in the future?
 
“EASEE’s system is powered by batteries with a service life of around three years. In the medium term, however, the system will become rechargeable so that patients feel even more independent when wearing it. In addition, we intend to make the system capable of self-learning, so that we can detect emerging epileptic seizures and stop them immediately by applying a reactive electrical stimulus. Also, considerations are well underway to apply the EASEE system to other clinical conditions. It may be feasible to support the rehabilitation phase of stroke patients. These future improvements and new indications will be studied clinically and reviewed by regulatory authorities prior to commercialization. However, the top priority is now to launch EASEEon the European market for patients suffering from epilepsy.”