Newronika Receives CE Mark for αDBS®

Newronika S.p.A. has received CE Mark certification for the latest commercial release of αDBS®, its adaptive deep brain stimulation system, now including full integration with WebBioBank™, Newronika’s proprietary cloud-based neural data platform.

This regulatory milestone marks the first approval for an adaptive DBS system that continuously senses neural activity and automatically adjusts stimulation according to patient-specific adaptive therapy settings, transmitting the data into a fully integrated neural data cloud platform.

Built on more than 20 years of advanced research and development, Newronika’s platform understands the brain’s signals and is designed to deliver better outcomes with fewer side effects, fewer clinical visits, and a reduced burden on both patients and clinicians.

“This certification validates our vision of a fully connected, data-driven approach to neuromodulation therapy, and opens a new era in personalized treatment for patients living with Parkinson’s disease and other neurological conditions.” Lorenzo Rossi, PhD, Co-Founder, CEO & CTO of Newronika.

Conventional Deep Brain Stimulation delivers fixed stimulation, regardless of how a patient’s brain state changes throughout the day. αDBS® is different by design.

Powered by a patented Adaptive Therapy Stim Engine, αDBS® continuously senses local field potential (LFPs), reading the brain’s signals in real time and adjusting the stimulation to keep each patient within their optimal therapeutic window.

The αDBS® system includes an implantable pulse generator (IPG), a physician interface, and a patient remote that enables seamless at-home data collection. Together, these components enable a connected care model where patient data is transmitted continuously, and clinicians gain longitudinal data that may support ongoing therapy optimization over time.

WebBioBank™: The Data Infrastructure Behind Personalized Neuromodulation

Central to this CE Mark release is the full integration of WebBioBank™, Newronika’s purpose-built neural data platform, directly connected to the αDBS® implant. The platform collects and analyzes neuronal signals integrated with clinical data across participating centers, building a longitudinal, de-identified neural data repository that grows more powerful with every patient treated.

Originally developed with support from the Italian Ministry of Education and validated through peer-reviewed publications, WebBioBank™ has been used to uncover the neurophysiological dynamics of deep brain structures, characterize DBS mechanisms of action, and develop new adaptive DBS algorithms. The platform gives clinicians, researchers, and Newronika a shared analytical foundation to continuously advance personalized neuromodulation therapy.

WebBioBank™’s de-identification architecture is designed to ensure patient privacy across all participating centers.

Advancing Toward U.S. FDA Approval: The ADVENT Pivotal Trial

Alongside its European CE Mark, Newronika holds an Investigational Device Exemption (IDE) from the United States FDA, enabling the ADVENT pivotal trial, a study spanning the United States and the European Union, designed to support FDA approval of both conventional DBS (cDBS) and Newronika adaptive DBS (αDBS®) for the treatment of Parkinson’s disease.

In the United States, the device is investigational and limited by federal law to investigational use only. It has not been cleared or approved by the FDA.

Source: Newronika S.p.A.

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