Newronika Receives CE Mark Approval for AlphaDBS, Advancing Adaptive Deep Brain Stimulation for Parkinson's Disease

Newronika's AlphaDBS monitors the patient's brain activity and automatically adjusts stimulation levels in response to real-time neurophysiological feedback. This personalized approach optimizes symptom control while reducing side effects and minimizing the need for frequent programming adjustments by neurologists.

"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."

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.

With this regulatory milestone, Newronika is 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.

About Newronika

Newronika is a spin-off of Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico and the University of Milan, and s transforming deep brain stimulation (DBS) through its adaptive platform that uses real-time patient data to optimize therapy. Headquartered in Milan, Italy, the company is committed to advancing neuromodulation beyond conventional limitations. With ongoing research collaborations, a CE Mark for its technology, and now an Investigational Device Exemption from the FDA, Newronika stands at the forefront of next-generation therapeutic innovation for neurological disorders.

For more information, visit www.newronika.com or follow us on LinkedIn.

Contact
Michael Fattore
CFO
+39 02 84109381
info@newronika.com 

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