AlphaDBS (αDBS) by Newronika: status and timeline

AlphaDBS (αDBS)

Make adaptive deep brain stimulation the standard for Parkinson's: stimulation that tracks the brain's changing state through the day, so patients get more symptom-free time and fewer side effects than fixed settings give.

DeployStage 4 of 5

CE marked and sold in Europe; ADVENT US/EU pivotal trial implanted its first patient Sept 2026

Updated 11d agoChecked 11 Oct0 updates this week

Milestones

Next · Enrol 104 patients at up to 18 US and EU sites

FDA IDE for a pivotal US trial2025Complete.
CE mark for AlphaDBS24 Mar 2025Complete.
CE mark for release with WebBioBank cloud link14 Jul 2026Complete.
First ADVENT participant implanted (Monza)21 Sep 2026Complete.
Enrol 104 patients at up to 18 US and EU sitesNowCurrent milestone.
US premarket approval applicationNot yet reached.

Most important updates

Current obstacles

Not yet approved in the USThe device is investigational in the US; approval depends on ADVENT, which compares adaptive and conventional modes blind in 104 patients.
Competing with MedtronicMedtronic already sells adaptive DBS approved in Europe and the US, so Newronika must win on results or ease of use.

Physics limits

A noisy, indirect symptom markerLocal field potentials are the blurred sum of thousands of neurons and are also shifted by movement, sleep and medication, so mapping them to how a patient feels is imperfect.
Stimulation drowns out the signalThe electrodes must record microvolt brain rhythms while delivering volt-scale pulses nearby, so sensing has to reject huge stimulation artefacts.

How it works

3 parts

Leads

Electrodes deep in the brain

As in standard DBS, electrodes sit in the subthalamic nucleus, a motor control hub, and deliver electrical pulses that calm Parkinson's symptoms.

Listening

Reads local field potentials

The same electrodes record local field potentials, the summed electrical rhythm of nearby neurons, which change as symptoms rise and fall.

Adjusting

Keeps stimulation in a target window

A stimulation engine compares the signal with patient-specific settings and raises or lowers stimulation automatically to stay in the window.

Spec sheet

Spec	AlphaDBS (αDBS)
Sensed signal	Local field potentials^R (reported)
System	Implanted generator, clinician interface, patient remote^R (reported)
ADVENT enrolment	104 patients^R (reported)
ADVENT sites	Up to 18 (US and EU)^R (reported)
EU indication	Levodopa-responsive Parkinson's, adjunct^R (reported)

^R reported by the company

Update log

3 updates

About Newronika

The team behind AlphaDBS (αDBS)

Newronika

Adaptive deep brain stimulation (αDBS)

Newronika is a Milan medtech company spun out of the Policlinico hospital and the University of Milan. Its αDBS implant reads brain signals and adjusts deep brain stimulation for Parkinson's on its own, minute by minute.

AlphaDBS won its CE mark in March 2025; a new release linked to the WebBioBank cloud got CE mark in July 2026.
First patient implanted in the ADVENT pivotal trial on 21 September 2026 in Monza, Italy.
ADVENT (104 patients, up to 18 US and EU sites) runs under an FDA IDE and is meant to support US approval.

Company profile →

Headquarters: Italy
Status: Private
Valuation: private
Works in: NeurotechBrain stimulation implants
Coverage: 1 program · 3 updateslatest 11d agochecked 11 Oct
Partners: Fondazione IRCCS Ca' Granda Ospedale Maggiore PoliclinicoFondazione IRCCS San Gerardo dei Tintori
People: Lorenzo Rossi (opens webdisclosure.com)Co-Founder, CEO and CTO

Spec

AlphaDBS (αDBS)

Sensed signal

Local field potentials^R (reported)

System

Implanted generator, clinician interface, patient remote^R (reported)

ADVENT enrolment

104 patients^R (reported)

ADVENT sites

Up to 18 (US and EU)^R (reported)

EU indication

Levodopa-responsive Parkinson's, adjunct^R (reported)

AlphaDBS (αDBS)

Milestones

Most important updates

Current obstacles

Physics limits

How it works

Electrodes deep in the brain

Reads local field potentials

Keeps stimulation in a target window

Spec sheet

Update log

Wed 30 Sep

Tue 14 Jul

Mon 24 Mar 2025

About Newronika

Current obstacles

Physics limits

How it works

Electrodes deep in the brain

Reads local field potentials

Keeps stimulation in a target window

Spec sheet

Update log

Wed 30 Sep

Tue 14 Jul

Mon 24 Mar 2025

About Newronika