The Italian neuromodulation startup Newronika has secured a European approval for its closed-loop, adaptive implant for people with Parkinson’s disease, offering a deep-brain stimulation approach to help control its symptoms.
The company’s AlphaDBS system continuously adjusts its output based on real-time brain signals, instead of the conventional therapy of fixed stimulation doses. The personalized approach aims to reduce side effects as well as the need for device reprogrammings and updates by neurologists.
“The CE Mark approval of AlphaDBS is a defining moment for Newronika and for the field of deep brain stimulation,” the company’s co-founder and CEO, Lorenzo Rossi, said in a statement. “This certification validates our vision of bringing truly adaptive neuromodulation to patients. We are excited to bring this technology to market and to set a new standard in the treatment of Parkinson's disease.”
Newronika—which was spun out of the University of Milan and Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Hospital—said it aims to launch AlphaDBS in Europe this year.
Its greenlight follows up on Medtronic’s CE mark for adaptive deep-brain stimulation, which was obtained in early January. That green light enabled more personalized therapies for patients who have already been implanted with its Percept neurostimulators and BrainSense recording technology—and allowed the medtech giant to roll out closed-loop therapy the same day, essentially as a software update.
Medtronic secured an FDA approval shortly thereafter. The company said the approach had spent more than 10 years in development, and that more than 40,000 Percept patients worldwide may be eligible for the therapy.
Newronika, meanwhile, recently received a go-ahead from the FDA to conduct a U.S. clinical trial for AlphaDBS. That study will compare adaptive therapy to conventional deep-brain stimulation in patients with advanced Parkinson’s.
Last month, the company also raised 13.6 million euros, or about $14.7 million, in a series B financing round. The financing was led by new investor Fondazione ENEA Tech e Biomedical, and joined by existing backers Indaco Venture Partners SGR, Innogest SGR, Wille Finance, TNBT Capital and F3F. In addition, Newronika has received a research grant from the Michael J. Fox Foundation.