Newronika’s adaptive DBS system to launch this year in Europe
AlphaDBS for Parkinson's awarded CE Mark in EU; US trial being planned
Newronika is preparing for the commercial launch of AlphaDBS — a next-generation adaptive deep brain stimulation (DBS) system for treating Parkinson’s disease — at selected markets in Europe this year, following CE Mark approval in the European Union.
That’s according to a company press release, in which Newronika called the award of the CE Mark a “regulatory milestone.”
“The CE Mark approval of AlphaDBS is a defining moment for Newronika,” said Lorenzo Rossi, PhD, the company’s cofounder and chief technology officer. “This certification validates our vision of bringing truly adaptive neuromodulation to patients.”
In the EU, a CE Mark is required for products to be sold commercially — it ensures that companies worldwide meet the same standards. Such certification confirms that AlphaDBS complies with the safety, health, and environmental protection regulations set by the European Commission, the EU’s regulatory authority.
Additionally, Newronika is planning to launch a pivotal clinical trial in the U.S. as the company “[advances] its global expansion,” the release stated. The U.S. Food and Drug Administration (FDA) granted Newronika an investigational device exemption that will allow it to be used in a clinical study, per the company.
Adaptive DBS allows for customized stimulation in patients’ brains
Parkinson’s disease is caused by the loss of dopaminergic neurons, or nerve cells that produce dopamine, a signaling molecule involved in motor control. The loss of these cells disrupts the normal circuitry of the brain, leading to disease symptoms that include tremor, rigidity, and slowed movement.
DBS is a surgical treatment for Parkinson’s motor symptoms that aims to normalize the brain’s electrical activity by delivering targeted electrical stimulation. Such treatment has been shown to help restore a more typical nerve-firing pattern and, in turn, ease disease symptoms.
The procedure involves implanting fine wires attached to electrodes in target brain regions, which are connected to a small pacemaker-like device placed under the skin. That device delivers the electrical signals.
Conventional DBS delivers constant stimulation at fixed parameters, while adaptive DBS allows for customized stimulation.
AlphaDBS monitors patients’ brain activity and automatically adjusts stimulation levels based on real-time feedback from the brain. According to the company, this personalized approach minimizes the need for frequent adjustments in delivered stimulation, optimizing symptom control and reducing side effects.
We are excited to bring this technology to market. … [Newronika is aiming] to set a new standard in the treatment of Parkinson’s disease.
The system is a closed-loop design that records and analyzes brain signals in the areas where stimulation is applied, adjusting in real time to meet the patient’s needs. Brain activity data collected during therapy can be shared via the cloud, allowing physicians to monitor it remotely.
“We are excited to bring this technology to market,” Rossi said, adding that Newronika is aiming “to set a new standard in the treatment of Parkinson’s disease.”
The CE Mark approval was based on results from a clinical trial (NCT04547712) that assessed the device’s safety and efficacy compared with conventional DBS.
Patients initially received conventional and adaptive DBS through AlphaDBS during hospitalization, followed by one-month treatment for certain individuals at home.
Participants first underwent two days of experimental sessions during hospitalization, with one day for each type of stimulation. Patients were then assessed by neurologists, and those who did not experience severe side effects could continue into the long-term follow-up phase at home for one month, where they received two weeks of stimulation with each mode.
In the U.S., the FDA earlier this year approved an adaptive DBS system by Medtronic to treat people with Parkinson’s disease. That system has also earned a CE Mark approval.
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