A deep brain stimulation device called AlphaDBS has recieved CE Mark of approval to advance its roll out across Europe.
The AlphaDBS device, developed by Newronika, is a closed-loop DBS system that dynamically adjusts stimulation based on real-time brain signals.
The CE approval enables the company to commercialise AlphaDBS in Europe, bringing the treatment option to patients living with Parkinson’s disease and other neurological disorders.
“The CE Mark approval of AlphaDBS is a defining moment for Newronika and for the field of deep brain stimulation,” said Lorenzo Rossi, CTO and co-founder of Newronika.
“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 Parkinson’s disease.
DBS is a proven therapy for managing many symptoms of Parkinson’s disease and has been prescribed for a variety of neurological disorders. Hundreds of thousands of DBS implantations around the world have helped patients manage PD, dystonia, essential tremor, OCD, and more.
Conventional DBS devices deliver continuous stimulation at fixed settings. While the therapy has been effective for decades, new techniques and technology have allowed for significant improvement to the customisation of DBS therapy.
Newronika’s AlphaDBS monitors the patient’s brain activity and automatically adjusts stimulation levels in response to real-time neurophysiological feedback. This personalised approach optimises symptom control while reducing side effects and minimising the need for frequent programming adjustments by neurologists.
The CE Mark approval is based on clinical data demonstrating the safety and effectiveness of the AlphaDBS in delivering adaptive deep brain stimulation. Clinical trials for adaptive DBS have shown that patients experience more time without symptoms or side effects compared to conventional DBS, with improved overall quality of life and greater patient preference for the adaptive stimulation mode.
Newronika is now preparing for the commercial launch of AlphaDBS in select European markets in 2025. The company is also advancing its global expansion, including its recently announced Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA) to initiate a pivotal clinical trial in the United States.
