Minimally Invasive Epilepsy Treatment EASEE Receives FDA Breakthrough Device Designation
Heidelberg-based Precisis GmbH has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its EASEE brain stimulator. FDA's breakthrough devices program classifies medical devices that have the potential to enable more effective treatment of life-threatening or irreversibly debilitating diseases or conditions. The goal is to make them available to patients faster.
Precisis is a medical device company developing minimally invasive neurostimulation methods to free epilepsy patients from their seizures. With EASEE, electrodes are invisibly positioned underneath the scalp - directly on the skull bone, but outside the sensitive brain tissue. The electrodes deliver calming current to the diseased brain area in a precisely targeted and individually adapted manner. So far, the only neurostimulation or surgical therapies available for patients with focal epilepsy require complex interventions: Either a stimulation electrode is placed around the so-called vagus nerve in the neck area, or anchored deep in the brain for deep brain stimulation - or physicians surgically remove the affected brain areas.
EASEE, on the other hand, is not only minimally invasive, but the product also allows treatment to be customized to each patient. EASEE relies on anatomical precision and takes into account the specific disease history of each patient.
"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", said Prof. Dr. Schulze-Bonhage from the University of Freiburg, Germany, who is responsible for the clinical studies.
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, adds: "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."
Several clinical studies have already demonstrated the high efficacy of EASEE to inhibit epileptic seizures. In October 2021, the company closed a 20 million euro financing round with Cochlear Limited, the global leader in implantable hearing solutions. By classifying EASEE as a "Breakthrough Device," the FDA now also recognizes the potential innovative power of the new treatment method.
About EASEE
EASEE is an acronym for "Epicranial Application of Stimulation Electrodes for Epilepsy". It is a system for individualized brain stimulation, which is precisely placed above the origin of the epileptic seizure in the brain, but is surgically inserted only underneath the scalp. This means that the skull bone is not opened, and the brain itself remains untouched.
The thin platelet electrodes are not visible from the outside and ensure unrestricted freedom of movement for patients. The therapeutic impulses can be individually customized for each patient, and regular modifications can be made throughout the duration of the treatment.
23 February, 2022
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