Newronika Announces First Participant Implanted in ADVENT Pivotal Study

Milestone initiates Newronika's international pivotal study comparing adaptive and conventional deep brain stimulation for Parkinson's disease

MILAN, Sept. 30, 2026 /PRNewswire/ -- Newronika S.p.A., a medical technology company developing adaptive deep brain stimulation therapies, today announced that the first participant in the pivotal ADVENT study has received the αDBS® implant. The procedure was performed on September 21^st at the Hospital Fondazione IRCCS San Gerardo dei Tintori in Monza.

The milestone marks an important step in the ADVENT pivotal study, which is currently enrolling participants.

ADVENT is evaluating Newronika's αDBS® adaptive deep brain stimulation system in people with Parkinson's disease who have been referred for bilateral deep brain stimulation of the subthalamic nucleus.

"Completing the first implantation procedure in the ADVENT study at an Italian study site is an important milestone for Newronika and for the clinical development of adaptive deep brain stimulation," said Lorenzo Rossi, Co-Founder and CEO of Newronika. "This study is designed to generate rigorous evidence by comparing adaptive and conventional stimulation in the same participants. We are grateful to the participant, the clinical team, and all the investigators contributing to this international study."

"Performing the first implantation in ADVENT marks an important milestone for the study and for the neuromodulation program at Fondazione IRCCS San Gerardo dei Tintori, reflecting our multidisciplinary team's commitment to advancing surgical care for people with Parkinson's disease," said Prof. Giorgio Carrabba, Principal Investigator for ADVENT at Fondazione IRCCS San Gerardo dei Tintori. "We thank the participant for their trust and the entire clinical team for their dedication as we begin this important phase of clinical research."

About the ADVENT study

ADVENT—registered on ClinicalTrials.gov as NCT06891781—is a prospective, multicenter, randomized, double-blind crossover study comparing the safety and effectiveness of adaptive and conventional deep brain stimulation delivered by Newronika's αDBS® system.

The study is expected to enroll 104 adults with idiopathic Parkinson's disease who have been referred for bilateral deep brain stimulation of the subthalamic nucleus. Up to 18 specialist clinical sites across the United States and the European Union are expected to participate.

Because ADVENT uses a crossover design, each participant experiences both conventional and adaptive modes of stimulation in a randomly assigned order. Participants and the clinicians assessing their outcomes remain blinded to the active mode during the comparative study periods.

Newronika received FDA approval of an Investigational Device Exemption, allowing the company to initiate the ADVENT pivotal study in the future. The study is intended to support a future Premarket Approval application for Newronika's DBS system in the United States.

Enrollment is currently underway at participating study sites in Italy and soon in the United States. Additional information about the study, including general eligibility criteria, is available on ClinicalTrials.gov under NCT06891781.

In the European Economic Area, the AlphaDBS® is CE-marked for conventional or adaptive deep brain stimulation as an adjunctive therapy to reduce symptoms of levodopa-responsive Parkinson's disease that are not adequately controlled by medication.

About Parkinson's disease and deep brain stimulation

Parkinson's disease is a progressive neurological condition that can cause a range of symptoms, including movement-related symptoms such as slowness of movement, stiffness, and tremor.

Deep brain stimulation is an established treatment option for selected people whose symptoms are not adequately controlled by medication. Conventional DBS delivers stimulation using clinician-programmed settings that remain constant until they are adjusted. Adaptive DBS is designed to respond dynamically to recorded brain activity and adjust the stimulation within parameters established by the treating clinical team.

About Newronika

Newronika S.p.A. is a Milan-based medtech company and spin-off of two of Italy's leading research institutions — Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico and the University of Milan. Built on more than 20 years of advanced research and development, Newronika develops αDBS® technology that continuously senses, analyzes, adapts to, and learns from brain signals.

Parkinson's disease is where we start. The brain is where we're going.

For more information, visit www.newronika.com

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 U.S. Food and Drug Administration. αDBS® is a registered trademark of Newronika S.p.A.

Media contact

Communications & Investor Relations
Newronika S.p.A.
Tel: +39 02 84109381
Email: [email protected]
Web: www.newronika.com

View original content to download multimedia:https://www.prnewswire.com/news-releases/newronika-announces-first-participant-implanted-in-advent-pivotal-study-302893390.html

SOURCE Newronika S.p.A.