The last unknown realm humanity has yet to conquer, the "brain," is at the center of a heated tech war. While Elon Musk's "Neuralink" focuses on an invasive approach that implants a chip in the brain, on the other side of the Atlantic in Barcelona, Spain, there is a corporations aiming to conquer brain disease with just a "cap." That is Neuroelectrics, co-founded in 2011 by Ana Maiques and Giulio Ruffini.
The first battleground is epilepsy. Neuroelectrics recently wrapped up its pivotal trial and is about to file for marketing authorization with the U.S. Food and Drug Administration (FDA). If approved, it will clinch the world's first epilepsy treatment title among noninvasive neuromodulation devices. Starting with this "beachhead" of epilepsy, the company plans to expand indications across brain diseases and reshape the brain disease market.
The next target market after the United States is Korea. At the EU business hub of "KIMES 2026" at COEX in Seoul on the 19th, business development director Rafal NOWAK told ChosunBiz, "We are closely reviewing the possibility of a 'fast track' for Ministery of Food and Drug Safety (KFDA) approval," adding, "The possibility of local production (Sub-manufacturing) in Korea is also open."
◇Seizures plunge 44% by running microcurrent through the brain… aiming to replace surgery
Neuroelectrics' core weapon is a cap called "Starstim." The device is a noninvasive neuromodulation platform that precisely measures EEG through up to 32 electrodes while delivering fine electrical stimulation to specific areas.
Nowak said, "Our equipment has two modalities. One records EEG to diagnose whether seizures occur, and the other injects microcurrent into the brain to stimulate or suppress specific areas," adding, "It especially reduces seizure frequency dramatically by lowering brain excitability in patients with 'drug-resistant focal epilepsy' that is not controlled by medication."
Currently, the options for drug-resistant patients are limited to risky surgeries such as "resective brain surgery," which removes part of the brain, or "deep brain stimulation (DBS)," which implants a chip. Nowak emphasized, "Surgery is irreversible and carries high risks of language and cognitive decline, but Starstim aims to deliver surgery-comparable outcomes while being a noninvasive approach that does not pierce the skull."
The differentiator is the software, namely "NeuroTwin." Like a pilot training on a simulator, it creates a digital replica of the brain in a virtual world based on the patient's MRI and EEG data. NeuroTwin simulates various electrical stimulations on this virtual brain to determine the optimal intensity and location before actual treatment. In a pilot clinical study conducted at Boston Children's Hospital affiliated with Harvard Medical School, the median seizure frequency among drug-resistant patients fell by 44%.
Nowak added, "When unblinding of the clinical data takes place in Apr., more refined figures will be released," noting, "We expect full-scale commercialization to be possible around next year."
◇"Korea is next after the U.S.… exploring collaboration with Samsung Medical Center"
The ambition does not stop at epilepsy. The company is currently conducting phase 3 trials for ADHD, autism, and depression, and is also running an Alzheimer's pipeline. In a recently announced clinical study for depression, 35 patients treated at home for eight weeks saw a 64% median reduction in their Montgomery-Åsberg Depression Rating Scale (MADRS) scores.
Neuroelectrics is putting particular effort into the Korean market. Nowak said, "Korea is aging rapidly and has excellent medical infrastructure, making it the market where our technology can be used best," adding, "We are exploring collaboration with Samsung Medical Center and continuing discussions via email." During this visit to Korea, the company aims to form partnerships with about 10 domestic medical institutions, including Samsung Medical Center.
To immediately scale up production from the current annual level of 400 units to several thousand or more, the company has also left open the possibility of series B and C funding rounds. Nowak said, "An era is coming when patients will receive 20 to 30 minutes of treatment a day at home instead of on a hospital bed," adding, "The 2 mA microcurrent we use is very safe. We will accelerate so that Korean patients can enjoy this benefit sooner."