Newronika, a Milan spin-off of the Policlinico hospital foundation and the University of Milan led by co-founder and CEO Lorenzo Rossi, makes AlphaDBS, a deep brain stimulator for Parkinson's disease. Unlike conventional systems with fixed settings, it records local field potentials from the implanted electrodes and uses the beta-band signal to compute "a new stimulation value" every second, according to CORDIS.

The European Innovation Council granted €2,499,999 towards a €3.73 million project from March 2023 to February 2025. The final report says a European double-blind crossover study was completed and supplied the data for CE marking under the Medical Device Regulation for both conventional and adaptive modes, that CE certification was obtained, and that approvals for the international ADVENT trial, designed to support US approval, were secured. It says these results helped raise the first tranche of a Series B of about €13 million. In February 2025 Newronika announced a €13.6 million Series B led by Fondazione ENEA Tech e Biomedical.

€2.50MEIC grant, 67% of a €3.73M project
CEUnder MDR, conventional and adaptive modes
~86%Blinded patient preference for adaptive mode
€13.6MSeries B, February 2025

Company file

Legal entity
Newronika S.p.A., Milan; Newronika USA Inc.
CEO
Lorenzo Rossi, co-founder
Origin
Spin-off of Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico and University of Milan
Product
αDBS (AlphaDBS) system with WebBioBank data platform
Investors
ENEA Tech e Biomedical, Indaco, Innogest, Wille Finance, TNBT Capital, F3F
EIC project
alphadbs, 1 Mar 2023 to 28 Feb 2025, closed
EIC funding
Grant first

Where Newronika Stands Now

In July 2026 Newronika received CE certification for the latest commercial release of αDBS, integrated with its WebBioBank cloud platform for neural data, and called it "the first approval for an adaptive DBS system" that also transmits data into such a platform, according to its announcement. The qualifier matters: Medtronic won a CE mark for its BrainSense adaptive DBS in January 2025, Medtronic said, and US approval followed that year. Newronika holds an FDA investigational device exemption for ADVENT, a pivotal trial in the US and EU. Its device remains investigational in the United States.

"This certification validates our vision of a fully connected, data-driven approach to neuromodulation therapy."

Lorenzo Rossi, co-founder and CEO, Newronika, July 2026

The Technology: Stimulation That Follows the Brain

Conventional deep brain stimulation runs at fixed settings, and patients spend 20-30% of the day with symptoms or side effects because their needs fluctuate, the report says. AlphaDBS reads beta-band activity, which changes with medication and movement, and raises or lowers stimulation accordingly. Clinicians can follow patients' brain signals remotely through the cloud.

What the EIC Project Promised, and What CORDIS Shows

The project aimed to finish clinical validation and regulatory approval. The report documents both, plus hardware and software upgrades for manufacturing. It is candid about limits: the European study "was not designed to assess the superiority of adaptive DBS", and preliminary results showed adaptive stimulation "at least as effective" as conventional, with most patients preferring it blind. It said the system would "soon" be sold in a few research-intensive European centres. CORDIS lists the project as closed.

  1. European clinical studyDeliveredDouble-blind crossover.
  2. CE mark under MDRDeliveredBoth modes.
  3. US trial approvalDeliveredFDA IDE for ADVENT.
  4. Commercial salesUnverifiedFew centres, no figures.

The Money

The Series B also included existing investors Indaco Venture Partners, Innogest, Wille Finance, TNBT Capital and F3F, and followed a grant from the Michael J. Fox Foundation, Innogest said. Newronika's revenue, implant numbers and how it will fund the ADVENT trial are not public.

What Cannot Be Checked

Questions for the EIC

How many αDBS systems have been implanted commercially, whether ADVENT has started enrolling, how it will be financed, and how Newronika plans to compete with Medtronic's approved adaptive system are not public.

Why Europe Should Care

Medtronic presents adaptive deep brain stimulation as brain-computer interface technology for Parkinson's. Newronika is a European developer with its own CE-marked system. The EIC helped it through the trial and certification; the larger market is being opened by an established US competitor.

What the project promised

Clinical validation and regulatory approval of an adaptive DBS system for Parkinson's.

What the record shows

A completed European study, CE marking, an FDA-approved pivotal trial design and a €13.6 million Series B.

The Verdict

Delivered, market race ahead

Newronika did what the EIC funded. Turning a CE mark into sales against Medtronic, and winning US approval, are the tests still to come.

Newronika and the EIC have not been asked for comment for this article. It is based entirely on public records and published statements, linked throughout.