Newronika's AlphaDBS System Secures CE Mark Approval for Adaptive Parkinson's Therapy

Italian neuromodulation startup Newronika has obtained European approval for its innovative AlphaDBS system, a closed-loop, adaptive deep brain stimulation (DBS) implant designed to treat Parkinson's disease. This breakthrough technology represents a significant advancement in the field of neuromodulation, offering personalized treatment that continuously adjusts based on real-time brain signals.

Adaptive DBS: A New Frontier in Parkinson's Treatment

The AlphaDBS system sets itself apart from conventional DBS therapies by utilizing a dynamic approach to stimulation. Instead of delivering fixed stimulation doses, the device adapts its output in response to the patient's brain activity. This personalized method aims to enhance treatment efficacy while minimizing side effects and reducing the frequency of device reprogramming by neurologists.

Lorenzo Rossi, Newronika's co-founder and CEO, emphasized the significance of this approval, stating, "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."

European Launch and Global Expansion

With CE Mark approval secured, Newronika plans to launch AlphaDBS in Europe later this year. The company's ambitions extend beyond the European market, as they have recently received FDA approval to conduct a clinical trial in the United States. This study will compare the efficacy of adaptive therapy to conventional DBS in patients with advanced Parkinson's disease.

Financial Backing and Research Support

Newronika's progress has been bolstered by significant financial support and research grants. The company recently completed a Series B financing round, raising €13.6 million (approximately $14.7 million USD). Led by new investor Fondazione ENEA Tech e Biomedical, the round also saw participation from existing backers including Indaco Venture Partners SGR, Innogest SGR, Wille Finance, TNBT Capital, and F3F.

Additionally, Newronika has received a research grant from the Michael J. Fox Foundation, further validating the potential impact of their technology on Parkinson's disease treatment.