#Italy #Milan #Parkinsons #Newronika #AlphaDBS

Newronika's Milestone: CE Mark Approval for AlphaDBS

In a significant advancement for neuromodulation, Newronika has officially received the CE Mark approval for its cutting-edge device, AlphaDBS. This groundbreaking system is designed for deep brain stimulation (DBS) and aims to transform treatment approaches for individuals suffering from Parkinson's disease and other neurological disorders.

The Role of AlphaDBS

AlphaDBS stands out in the realm of DBS due to its innovative closed-loop system, which dynamically adjusts stimulation based on real-time signals from the brain. Traditionally, DBS devices operate on fixed settings, offering continuous stimulation regardless of the patient's condition. In contrast, AlphaDBS is engineered to monitor a patient’s brain activity closely, making automatic adjustments based on neurophysiological feedback. This means that patients experience a more effective treatment tailored to their unique needs.

Clinical Significance

The medical community widely recognizes deep brain stimulation as a viable therapy for managing various symptoms associated with Parkinson's disease. Historically, this approach has successfully aided hundreds of thousands globally, providing relief to those dealing with conditions like dystonia, essential tremor, and obsessive-compulsive disorders. With the advent of AlphaDBS, there is a promising shift toward personalized medicine, enhancing the overall patient experience while minimizing side effects often associated with conventional DBS therapies.

Insight from Newronika's Leadership

Lorenzo Rossi, CTO and co-founder of Newronika, expressed the company's excitement regarding this regulatory milestone. He stated, “The CE Marking of AlphaDBS is a crucial moment for Newronika and the field of deep brain stimulation. This certification validates our vision of providing patients with truly adaptive neuromodulation. We look forward to bringing this technology to market and setting a new standard for the treatment of Parkinson’s disease.”

Clinical Data and Future Prospects

The CE Mark approval was supported by robust clinical data demonstrating the safety and efficacy of AlphaDBS. Clinical trials have illustrated that patients utilizing adaptive deep brain stimulation report spending significantly more time without symptoms or side effects when compared to those with conventional treatments. Importantly, these studies revealed enhanced overall quality of life, as patients expressed a clear preference for the adaptive stimulation mode.

With this milestone, Newronika is gearing up for the commercial launch of AlphaDBS in select European markets in 2025. The company is also advancing its global expansion efforts, including recent developments with the U.S. Food and Drug Administration (FDA), which granted an Investigational Device Exemption (IDE) for a pivotal clinical trial in the United States.

About Newronika

Founded as a spin-off from the Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico and the University of Milan, Newronika's mission is to revolutionize deep brain stimulation through the use of real-time patient data to optimize therapies. Based in Milan, Italy, the company is committed to pushing the boundaries of neuromodulation, backed by ongoing research collaborations and the latest in regulatory approvals.

For more information about Newronika and its pioneering technology, visit www.newronika.com or follow them on LinkedIn.