Newronika Announces CE Mark Approval for AlphaDBS™ System for Parkinson's Disease
MILAN, Feb. 23, 2021 /PRNewswire/ -- Newronika, a spin-off of the world-class neurological research center Policlinico of Milan and University of Milan, announced today it received CE Mark approval for its AlphaDBS System.
AlphaDBS is the first rechargeable deep brain neurostimulation system that can continuously record and interpret bioelectrical neuronal activity in the brain areas where stimulation is delivered. AlphaDBS's proprietary sensing technology records noise-free local field potentials while electrical stimulation is delivered. The AlphaDBS system is also capable of closed-loop stimulation in which the current delivered is automatically adjusted for the individual needs of each patient, a true revolution in DBS care and personalized medicine. This feature is currently under clinical evaluation. When available, it will be the most important innovation in the DBS field. The device also collects brain signals critical to developing new treatments using a first-of-its-kind telemonitoring platform between patients and physicians.
"The ability to collect real-time brainwave information from patients with Parkinson's disease during electrical stimulation treatment provides clinicians with a unique opportunity to understand the disease process and how effective stimulation is while patients participate in normal activities of life," said Lorenzo Rossi, co-founder and CEO of Newronika.
"DBS is an established treatment for treating Parkinson's disease but there has been minimal innovation in how to deliver the therapy. The capability of AlphaDBS to collect real-time information from the brain with the potential to close the loop is a major advancement for a personalized therapy, which is only delivered when needed. Such an 'on demand' therapy holds the promise of better efficacy and less adverse effects than continuous stimulation," according to Jens Volkmann, MD, Professor and Chairman 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 deteriorate thereby reducing the amount of dopamine, a neurotransmitter important for movement and many other functions. According to the Parkinson's Foundation as many as 1 million people in the United States are affected and 10 million people worldwide. The cause remains unknown. Symptoms include slowness of movement, tremor, 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 medications. It involves surgically implanted electrodes in specific regions of the brain which are connected to an implantable device similar to a pacemaker. Over 175,000 people worldwide have received DBS systems.
About Newronika S.p.A.
Newronika (www.newronika.com) is the spin-off company of two of the world-leading research institutions in the field of neurology, the Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico Hospital and the University of Milan. Newronika restores brain and body functions with its innovative technology, translating their deep knowledge on bio-signal decoding into clinical practice with the aim of developing new treatments and improving existing ones. Newronika comprises a multidisciplinary team with expertise in neurophysiology, neurology, biomedical engineering, neuropsychology, bioinformatics, and biotechnologies.
SOURCE Newronika S.r.l
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