Newronika announced today that it received FDA investigational device exemption (IDE) for its deep brain stimulation (DBS) system.
The IDE enables Newronika to initiate a pivotal U.S. clinical trial to evaluate the safety and efficacy of the adaptive DBS system. It could aid patients with movement disorders, including Parkinson’s disease.
Milan, Italy-based Newronika said it marks a critical step as it aims to bring the neuromodulation solution to patients in the U.S. The company said it continues to progress toward global adoption of its next-generation, data-driven DBS technologies.
Newronika designed its adaptive DBS solution to ensure continuously optimized therapy through a patient-tailored approach. It says it could potentially greatly improve outcomes and reduce side effects compared with traditional DBS systems. The company said it expects the trial to take place at leading U.S. and international clinical centers. It will compare the performance of adaptive DBS against conventional DBS in patients with advanced Parkinson’s disease.
The company plans to use results to help secure regulatory approval for its AlphaDBS system in the U.S.
“Receiving an IDE from the FDA is a landmark achievement for Newronika,” said Dr. Lorenzo Rossi, Newronika co-founder and CEO. “It affirms the potential of our adaptive DBS system to fill an unmet need in the U.S. market, bringing personalized, real-time brain stimulation to patients who need it most. Our ultimate goal is to change the paradigm for managing neurological conditions worldwide, and this IDE moves us one step closer.”
