#Italy #Milan #Newronika #AlphaDBS #Parkinson

Newronika's AlphaDBS: A Game-Changer for Parkinson's Disease Treatment

In a significant breakthrough for Parkinson's disease management, Newronika has announced that its innovative device, AlphaDBS, has received CE Mark approval. This regulatory milestone paves the way for the commercialization of AlphaDBS across European markets, offering a groundbreaking treatment option for those afflicted with neurological disorders.

Newronika, a pioneering entity in the field of neuromodulation and adaptive deep brain stimulation (DBS), has developed AlphaDBS as a next-generation closed-loop DBS system. This advanced technology boasts the remarkable ability to dynamically adjust electrical stimulation based on real-time brain activity. Unlike traditional DBS devices, which provide continuous stimulation at fixed levels, AlphaDBS personalizes therapy to optimize patient outcomes, minimizing side effects typically associated with conventional approaches.

The therapeutic applications of DBS are well-documented; it is widely regarded as an effective treatment for managing various symptoms associated with Parkinson's disease, along with other neurological disorders such as dystonia and obsessive-compulsive disorder (OCD). Prior to the advancement represented by AlphaDBS, many patients had to endure the limitations of older DBS systems, which often required frequent recalibration to maintain therapeutic efficacy.

The innovative design of AlphaDBS allows it to monitor changes in the patient's neurophysiological state continuously. Leveraging real-time feedback, the system automatically adjusts stimulation levels, thereby optimizing symptom control. This state-of-the-art adaptive approach not only aims to enhance the quality of life for patients but also potentially reduces the frequency of in-clinic adjustments, alleviating the burden on healthcare providers.

Lorenzo Rossi, the Chief Technology Officer (CTO) and co-founder of Newronika, emphasized the importance of this approval. He stated, "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 Parkinson's disease."

Clinical trials leading to the CE Mark certification have produced compelling results. Participants who received treatment with AlphaDBS reported experiencing enhanced control over symptoms with fewer side effects when compared to traditional DBS methods. The data indicates that the personalized adjustments facilitated by the device result in a greater overall quality of life and higher patient satisfaction.

Looking ahead, Newronika is preparing for the commercial launch of AlphaDBS in selected European markets in 2025. In tandem with this expansion, the company is actively pursuing its growth strategy, which includes securing an Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA). This exemption allows the initiation of pivotal clinical trials in the United States, signifying the company's ambition to broaden its reach and impact in the field of neurological disorder treatments.

Founded as a spin-off from Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico and the University of Milan, Newronika is at the cutting edge of therapeutic innovation in neuromodulation. By harnessing real-time patient data through its adaptive platform, the company is redefining how deep brain stimulation is applied, moving beyond the limitations of traditional methodologies.

For those interested in learning more about Newronika and its innovative solutions, further information can be found on their website at www.newronika.com or via their LinkedIn page.

As Newronika embarks on its next chapter with AlphaDBS, the hope is that this technology will not only transform individual patient care but also signal a new era in the management of Parkinson's disease and other neurological conditions.