Newronika Announces CE Mark Approval for AlphaDBS ™ System for Parkinson’s Disease



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MILAN, February 23, 2021 / PRNewswire / – Newronika, a spin-off of world-class neurological research center Policlinico in Milan and the University of Milan, today announced that it has received CE mark approval for its AlphaDBS system.

AlphaDBS is the first rechargeable deep brain neurostimulation system capable of continuously recording and interpreting bioelectric neuronal activity in areas of the brain where stimulation is delivered. AlphaDBS’s proprietary sensing technology records local field potentials without noise during electrical stimulation. The AlphaDBS System is also capable of closed loop stimulation in which the delivered current is automatically adjusted to the individual needs of each patient, a true revolution in DBS care and personalized medicine. This functionality is currently under clinical evaluation. When it becomes available, it will be the most significant innovation in the DBS field. The device also collects brain signals essential to the development of new treatments using a unique telemonitoring platform between patients and physicians.

“The ability to collect real-time brainwave information from patients with Parkinson’s disease during electrical stimulation treatment offers clinicians a unique opportunity to understand the disease process and the effectiveness of stimulation when patients participate in the normal activities of life, ”said Lorenzo Rossi, co-Founder and CEO of Newronika.

“DBS is an established treatment for the treatment of Parkinson’s disease, but there has been little innovation in the way the treatment is delivered. AlphaDBS’s ability to collect real-time information from the brain with the potential to close the loop is a major breakthrough for therapy, which is only delivered when needed. Such “on-demand” therapy promises better efficacy and fewer side effects than continuous stimulation, “says Jens Volkmann, MD, Professor and Chairman of the Department of Neurology, University Hospital Würzburg, Germany.

About Parkinson’s disease

Parkinson’s disease is a neurodegenerative disease in which cells in a part of the brain called the substantia nigra break down, reducing the amount of dopamine, a neurotransmitter important for movement and many other functions. According to the Parkinson Foundation, up to 1 million people in United States are affected and 10 million people worldwide. The cause remains unknown. Symptoms include slowness of movement, tremors, stiffness, and poor balance.

About deep brain stimulation

Deep brain stimulation is an approved, safe, and effective treatment for patients with advanced Parkinson’s disease that cannot be adequately controlled with medication. These are electrodes surgically implanted in specific regions of the brain that are connected to an implantable device similar to a pacemaker. Over 175,000 people around the world have received DBS systems.

About Newronika SpA

Newronika (www.newronika.com) is the spin-off company of two of the world’s largest research institutes in the field of neurology, the Fondazione IRCCS Ca’Granda Ospedale Maggiore Policlinico Hospital and the University of Milan. Newronika restores brain and bodily functions with its innovative technology, translating its in-depth knowledge of decoding bio-signals into clinical practice with the aim of developing new treatments and improving existing treatments. Newronika comprises a multidisciplinary team with expertise in neurophysiology, neurology, biomedical engineering, neuropsychology, bioinformatics and biotechnology.

SOURCE Newronika Srl

Related links

http://www.newronika.com

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