Newronika Wins EU Nod for Adaptive Deep Brain Stim

Newronika, a Milan-based deep brain stimulation (DBS) company, has obtained CE mark certification for the latest commercial release of αDBS, its adaptive deep brain stimulation system. The latest release comes integrated with WebBioBank, the company’s cloud-based neural data platform.

αDBS is powered by a patented Adaptive Stim Therapy Stim Engine and continuously senses local field potentials (LFPs) to read brain signals in real time, adjusting stimulation to stay within an optimal therapeutic window. It’s comprised of an implantable pulse generator (IPG), physician interface, and patient remote for at-home collection of data.

The company said the regulatory milestone marks the first approval for an adaptive DBS that continuously senses neural activity and automatically adjusts stimulation per patient-specific adaptive therapy settings, then transmits data into a neural data could platform. Newronika’s platform aims to provide better outcomes with fewer side effects, fewer clinical visits, and reduced burden on patients and clincians.

“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,” said Lorenzo Rossi, Ph.D., co-founder, CEO, and CTO of Newronika.

The company also has an IDE from the U.S. Food and Drug Administration (FDA) for its ADVENT pivotal trial spanning the U.S. and European Union. The trial hopes to support FDA approval of both conventional DBS and adaptive DBS to treat Parkinson’s disease.

More about Newronika’s WebBioBank

The WebBioBank neural data platform collects and analyzes neural signals integrated with clinical data from participating centers. This builds a longitudinal, de-identified neural data repository.

It was originally developed with support from the Italian Ministry of Education and validated through peer-reviewed publications. The databank has been used to reveal deep brain structures’ neurophysiological dynamics, characterize DBS mechanisms of action, and develop new adaptive DBS algorithms.

Newronika assures that WebBioBank’s de-identification architecture was designed to ensure patient privacy at each participating center.