Adaptive DBS may move to pivotal clinical trial after $14M raised

Newronika has secured €13.6 million (approximately $14.3 million) in a funding round to support a clinical trial of its adaptive deep brain stimulation (DBS) system. This system is designed to dynamically adjust stimulation in real time, improving Parkinson’s symptom control while reducing side effects. The funding announcement follows the U.S. Food and Drug Administration granting an investigational device exemption, allowing the system to be used in clinical studies in the U.S. Lorenzo Rossi, Newronika’s co-founder and CEO, stated that the Series B round reflects strong investor confidence in their mission to revolutionize DBS technology. The AlphaDBS system, already CE-marked in the European Union, is being tested in an ongoing small clinical trial (NCT04681534) in Italy, the Netherlands, and Poland. This study, involving about 15 patients, compares the safety, tolerability, and potential effectiveness of adaptive versus conventional DBS, with final results expected by the end of the year. Unlike traditional DBS, which delivers constant stimulation, AlphaDBS automatically adjusts based on real-time brain activity, providing more personalized therapy. The financing round was led by Italy’s Fondazione ENEA Tech e Biomedical, with contributions from several existing investors. In addition to supporting clinical trials, the funds will aid in product development, recruitment, and partnerships to advance Newronika’s technology in movement disorder treatment.