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Newronika's Major Milestone: CE Mark Approval for AlphaDBS

In a groundbreaking achievement, Newronika, an Italian company specializing in neuromodulation and adaptive deep brain stimulation (DBS), has secured CE Mark approval for its innovative AlphaDBS device. This next-generation closed-loop DBS system dynamically adjusts its stimulation in response to real-time brain signals, offering a promising treatment option for Parkinson's disease and other neurological disorders.

DBS has long been recognized as an effective therapy for managing the symptoms of Parkinson's disease, with numerous patients benefiting from the procedure globally. Traditional DBS devices rely on continuous stimulation at fixed settings, which, while effective for many, do not offer the personalized touch that modern technology can now provide. Newronika aims to change that with its cutting-edge AlphaDBS device.

The AlphaDBS sets itself apart by continuously monitoring the patient’s brain activity and adjusting stimulation levels accordingly. This means that the treatment is not only tailored to the patient's unique requirements, but it also optimizes symptom control while minimizing side effects. As a result, patients experience enhanced quality of life and require fewer adjustments from medical professionals, making the treatment process smoother and more efficient.

Lorenzo Rossi, CTO and Co-Founder of Newronika, noted, “The CE Mark approval of AlphaDBS is a defining moment for Newronika and the field of deep brain stimulation. This certification validates our vision of providing truly adaptive neuromodulation to patients. We are thrilled to bring this technology to market and set a new standard in Parkinson's disease treatment.”

Clinical trials have illustrated the effectiveness of the AlphaDBS in delivering adaptive deep brain stimulation. Results indicate that patients who used this device experienced reduced symptoms and adverse effects compared to those who received conventional stimulation treatments. As the trials progressed, patient preferences indicated a clear advantage toward the adaptive stimulation mode, with many finding greater relief and satisfaction in their treatment outcomes.

With the CE Mark approval secured, Newronika is gearing up for the commercial launch of AlphaDBS in various European markets in 2025. The company is also pushing forward with its strategies for global expansion, which includes a recent Investigational Device Exemption (IDE) granted by the U.S. Food and Drug Administration (FDA) for a pivotal clinical trial in the United States.

Founded as a spin-off from Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico and the University of Milan, Newronika is committed to transforming the landscape of deep brain stimulation. The company’s focus is on leveraging real-time patient data to fine-tune therapy, helping bridge the gap between traditional treatment methodologies and modern technological advancements.

As the medical community prepares for the rollout of AlphaDBS, Newronika's advancements in DBS technology represent a significant leap toward revolutionizing treatment options for patients suffering from Parkinson's disease and other related neurological conditions. With the potential to improve adherence to treatment and overall patient satisfaction, AlphaDBS may very well set a precedent for future innovations in neurologic care.

To learn more about Newronika and the AlphaDBS device, visit www.newronika.com or follow the company on LinkedIn for updates on their journey in advancing neurological treatment.

With their innovative approach and determination, Newronika is well on its way to reshaping the future of deep brain stimulation. Let’s keep an eye on their progress as they lead the charge into a new era of personalized healthcare.