Newronika’s AlphaDBS System Earns CE Mark in Europe

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by Diana Campelo Delgado |

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Newronika‘s AlphaDBS, an innovative deep brain stimulation (DBS) system being evaluated in patients with Parkinson’s disease, has received CE Mark approval in Europe.

The CE Mark is a seal of approval issued by the European Commission that means products have been assessed to meet pre-established safety, health, and environmental protection requirements. CE Marking also supports fair competition by holding all companies accountable to the same rules.

DBS is an established treatment for people with Parkinson’s disease who do not respond adequately to medical therapy. It is a surgical procedure in which electrodes are implanted in certain areas of the brain, generating electrical impulses to control abnormal brain activity.

“DBS is an established treatment for treating Parkinson’s disease but there has been minimal innovation in how to deliver the therapy,” Lorenzo Rossi, PhD, co-founder and CEO of Newronika, said in a press release.

AlphaDBS is a rechargeable, closed-loop system that records and interprets bioelectrical brain activity — signals called “local field potentials” — in the areas where stimulation is delivered and accordingly adapts moment-by-moment the amount of current to the patient’s needs. This represents a shift from current DBS systems that stimulate the brain continuously, even when it may not be needed.

“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,” Rossi added.

The company recently began a clinical trial (NCT04681534) evaluating the safety, tolerability, and potential effectiveness of adaptive DBS delivered through the AlphaDBS system in 15 Parkinson’s patients. Recruitment is ongoing in Italy and Poland. More information and contacts are available here.

The trial is divided into two parts. In the first, participants will be assigned to two days of experimental sessions, meaning one day each of conventional or adaptive DBS through AlphaDBS to determine its safety and potential effectiveness during hospitalization. In the second part of the study, patients will receive one-month treatment with conventional or adaptive DBS at home (two weeks each).

Secondary goals of the study include the evaluation of motor symptoms, uncontrollable involuntary movements (dyskinesia), reappearance or worsening of symptoms (“off” periods), and controller usability.

“[AlphaDBS] is a major advancement for a personalized therapy, which is only delivered when needed,” said Jens Volkmann, MD, PhD, professor and chairman of the department of neurology at the University Hospital Würzburg in Germany. “Such an ‘on demand’ therapy holds the promise of better efficacy and less adverse effects than continuous stimulation.”

Newronika is a spin-off company of Policlinico of Milan and the University of Milan, in Italy.