#USA #Milan #FDA Approval #Newronika #DBS Technology

Newronika's Innovative Step Forward in Neuromodulation

Newronika, a pioneer in adaptive deep brain stimulation (DBS) technology, has recently made headlines by obtaining an Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA). This crucial approval allows the company to initiate a pivotal clinical study evaluating the safety and effectiveness of its cutting-edge adaptive DBS system for patients suffering from movement disorders, including Parkinson's disease. This significant milestone is expected to expand the availability of personalized neuromodulation therapies in the United States.

A Game-Changer in Neuromodulation

The adaptive DBS system developed by Newronika promises to revolutionize the treatment of neurological disorders by providing continuous, real-time adjustment of stimulation based on live feedback from patients' brain signals. Dr. Lorenzo Rossi, the co-founder and CEO of Newronika, expressed that the granting of the IDE by the FDA is a definitive moment for the company. He stated, “It confirms the potential of our adaptive DBS system to address an unmet need in the U.S. market by providing personalized real-time brain stimulation for those who need it most.” With tailored treatment plans, the aim is to change the management of neurological diseases on a global scale.

Enhancing Patient Outcomes

Newronika's adaptive DBS utilizes advanced technology to ensure that therapy is continuously optimized, potentially leading to improved clinical outcomes compared to conventional DBS systems. This unique approach not only aims to enhance patients' overall health but also works to mitigate side effects commonly associated with traditional methods. The company's determination to push the boundaries of neurotechnology remains solid as it navigates the path toward commercial launch in Europe, the U.S., and beyond.

Dr. Jens Volkmann, the leading investigator of the trial, remarked that the FDA-approved study will allow them to thoroughly assess how well adaptive deep brain stimulation can outperform conventional treatment methods. “With the implementation of this adaptive neurotechnology, we are aspiring to provide more precise, personalized, and effective therapies for patients with Parkinson's disease, ultimately improving their quality of life,” he elaborated.

Upcoming Clinical Trials

The upcoming clinical trial will be conducted across renowned clinical centers in the United States and around the world. Researchers will compare the performance of the adaptive DBS technology against traditional DBS in patients with advanced Parkinson's disease. The findings from this study will be critical for the approval process of Newronika’s AlphaDBS system in the U.S., shaping the future of neurological intervention.

About Newronika

Founded as a spin-off from the University of Milan and the Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Newronika is based in Milan, Italy, and focuses on pushing the field of neuromodulation beyond existing limits. With ongoing research collaborations and now an FDA IDE approval, Newronika stands at the forefront of next-generation therapeutic innovations for neurological conditions.

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