Newronika has secured CE Mark approval for its AlphaDBS device aimed at the treatment of Parkinson’s disease (PD), in Europe.
This closed-loop deep brain stimulation (DBS) device claims to adjust the stimulation based on real-time signals.
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The approval is supported by the clinical data that has shown the device’s effectiveness and safety in adaptive DBS delivery.
Subjects in clinical trials experienced increased time with no symptoms or side effects against conventional DBS, with enhanced quality of life and a “preference” for the adaptive stimulation mode.
With this approval in place, Newronika is focusing on the commercial launch of the device in select European markets this year, thereby aiming to offer an alternative for PD and other neurological conditions.
Newronika co-founder and CTO Lorenzo Rossi said: “The CE mark approval of AlphaDBS is a defining moment for Newronika and for the field of deep brain stimulation.
“This certification validates our vision of bringing truly adaptive neuromodulation to patients. We are excited to bring this technology to market and to set a new standard in the treatment of PD.”
The company is also focusing on the device’s worldwide expansion, as evidenced by the recent investigational device exemption from the US Food and Drug Administration (FDA) for commencing a pivotal trial in the US.
According to the company, DBS has been a therapy leveraged in PD symptom management for decades, benefiting individuals globally.
The company’s technology aids in monitoring the activity of the individual’s brain and is said to automatically adjust simulation levels.
Its approach optimises the controlling of symptoms and minimises side effects as well as the requirement for recurrent programming adjustments made by neurologists.
The Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico and the University of Milan spun-off company Newronika is headquartered in Italy.
