Newronika has completed a €13.6m ($14.1m) Series B funding to advance the development of AlphaDBS, an adaptive deep brain stimulation (DBS) system for addressing the symptoms of Parkinson’s disease.
The completion of the company’s latest funding round comes hot on the heels of its receipt of an Investigational Device Exemption (IDE) for the DBS system from the US Food and Drug Administration (FDA).
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With the IDE in hand, the Italian company plans to initiate a pivotal trial of AlphaDBS in the US. Noting that the trial’s success will be critical in gaining US market clearance for the closed-loop brain neuromodulation implant, Newronika plans to compare the performance of AlphaDBS against conventional DBS approaches to managing symptoms in patients with advanced Parkinson’s disease.
DBS involves the implantation of a neuromodulation device in Parkinson’s disease patients that sends electrical signals to the brain to disrupt and manage the hallmark symptoms of the disease such as bodily tremors, rigidity, and slowness of movement.
AlphaDBS’s differentiating factor is that it optimises therapy for individual patients based on real-time feedback from their brain signals. According to Newronika, this approach holds the potential to improve patient outcomes and reduce side effects in contrast to traditional DBS approaches in which continuous pulses of electrical current are sent to the brain.
Newronika co-founder and CEO Dr Lorenzo Rossi commented: “This Series B round validates our commitment to transform the way deep brain stimulation is delivered.
“We aim to seamlessly integrate real-time neural data and machine learning into our DBS systems to create truly personalised therapies that surpass the capabilities of existing devices on the market.”
The Series B funding round was led by new Italian biomedical investor Fondazione ENEA Tech e Biomedical and featured participation from existing investors including Indaco Venture Partners and Innogest.
Newronika spun out from Italian research institute Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico Hospital and the University of Milan in 2016. The company completed a $9.6m Series A funding round in 2019.
Last month, Medtronic received CE marks under the European Union’s Medical Device Regulation (EU MDR) for the BrainSense adaptive deep brain stimulation (aDBS) system and electrode identifier (EI) for Parkinson’s disease therapy, a system that also delivers electrical signals to Parkinson’s disease patients based on real time feedback from their brain signals.
