Newronika Secures CE Mark for AlphaDBS System, Pioneering Adaptive DBS Therapy for Parkinson’s Disease
Newronika, a leader in neuromodulation technology, has received CE Mark approval for its groundbreaking AlphaDBS system – an intelligent deep brain stimulation (DBS) device that dynamically adapts therapy based on real-time neural activity. This milestone enables the company to introduce its next-generation adaptive DBS technology to European Parkinson’s disease patients and those with other neurological disorders.
The AlphaDBS system represents a significant advancement over conventional DBS devices, which deliver continuous, fixed stimulation. By continuously monitoring brain signals and automatically adjusting stimulation parameters, AlphaDBS provides personalized therapy that:
- Optimizes symptom control
- Reduces side effects
- Minimizes the need for manual reprogramming by clinicians
Clinical evidence supporting the CE Mark approval demonstrates AlphaDBS’s superior performance compared to traditional DBS, with patients experiencing:
- More symptom-free time
- Improved quality of life
- Strong preference for adaptive stimulation
“CE Mark approval validates our mission to revolutionize neuromodulation through intelligent, adaptive technology,” said Lorenzo Rossi, CTO and Co-Founder of Newronika. “AlphaDBS represents a new standard in personalized brain stimulation therapy.”
Newronika is preparing for commercial launch in select European markets in 2025 while advancing global expansion plans. The company recently received FDA Investigational Device Exemption (IDE) to initiate pivotal U.S. clinical trials, marking an important step toward worldwide availability of this innovative therapy.
