– Prevents anesthesia overdose and awareness during surgery by measuring and analyzing EEG biological signals

– Provides EEG measurement sensor, EEG signal amplifier, EEG numerical monitoring service

– Green light to advance into overseas markets in Japan, the Middle East, and Europe by CE certification in October

EEG, emitted by the activity of nerve cells in the brain, is a measurement index that can confirm brain health such as concentration and stress index, and is also used to diagnose brain diseases such as epilepsy, brain tumor, and consciousness disorder. We can lead a healthier life if we can properly measure and analyze the signals sent from the brain, where all human activities such as body movements, cognition, language, and senses are processed. With the motto of providing products and services that improve health and quality of life by measuring and analyzing human bio-signals based on brain waves, BrainU is a company that makes this wish a reality.

Located in Pangyo Technovalley, BrainU is a company that creates a new paradigm in the healthcare industry through the development of EEG-based medical and wearable devices, brain fusion R&D, AI and data research, and software development. Established in 2018, the company develops and sells devices that measure the degree of anesthesia. The company is conducting business in the medical field to prevent medical accidents such as excessive anesthetic injection and awareness during general anesthesia surgery.

Amid growing concerns about anesthesia-related medical accidents around the world, the use and interest of anesthesia depth monitoring in operation rooms, ICUs, and ERs are increasing, especially in advanced countries like the US. To localize medical devices and enter the global market, BrainU conducted research on concentration and cognitive function of the human body by utilizing EEG through joint research with KAIST, and through this, the company successfully developed the algorithm to quantify the changes in brain activity due to anesthesia on patients during surgery. The product developed in this way is the CAI system (anesthesia depth meter).

Major medical accidents that can occur by anesthesia are anesthetic overdose (accidental death due to anesthesia, etc.) and awareness (waking up during anesthesia). Hong Seung-gyun, the CEO of BrainU, said, “Anesthetic overdose, that is, if the anesthesia is overly done, situations like cardiac arrest or respiratory arrest can occur, which can lead to a serious medical accident that may lead to disability or death of the patient. Even in the case of awareness, waking up during surgery, cognitive dysfunction or trauma may occur. Our CAI monitoring system can prevent such medical accidents in advance.” BrainU’s CAI monitoring system collects and records vital signs such as EEG of patients during surgery, and provides indexed values (awareness: 80-99, correct anesthesia: 40-60, death: 0) to the medical staff.

BrainU’s CAI system consists of CAIs sensor that measures EEG, EEG amplifier that amplifies fine brainwave signals, and monitor that quantifies signal data from 0-100. Among them, the CAIs sensor has been miniaturized (7% horizontally and 17% vertically smaller compared to competing products) to secure the difference in the size of the patient’s forehead and the space for attaching other sensors. The skin trouble was minimized along with the improvement of adhesive power by using the harmless substance hydrogel.

Also, through the improvement of the signal processing module and its own algorithm, the amplifier secured 13 seconds faster response and stability against external electric noise compared to competitors. In particular, the use of wireless communication between the amplifier and the monitor eliminated the interference caused by the line, and the fact that the usability is increased by configuring a miniaturized system is another distinctive advantage of the BrainU CAI system. Hong said, “We increased the accuracy of our product by adding deep learning techniques using clinical data. With the algorithm to measure the consciousness level by analyzing the EEG analysis on the entire section that began from the brain activity analysis theory, we can extend to brain research that is accurate and diverse” about the excellence and scalability of the algorithm.

BrainU supplied products to 70 hospitals including general hospitals after completing domestic approvals and permits last year. It has already signed a supply contract of 5,000 units (10 billion won in net income) with China for five years to advance overseas, and it plans to acquire CFDA within this year. The company has also signed an NDA agreement with Japanese and Brazilian companies and is investigating the local market. Hong said, “Certification and permission are the most time-consuming part of the medical device business. In order to enter the overseas market, certification and permission for each country of entry must be considered. We plan to first enter Southeast Asian countries by using the Korean certification, and when we receive CE certification in October, we plan to enter the Middle East and Europe. Lastly, we will enter the US market upon receiving FDA.”

BrainU is currently in the MSS TIPS program. It is preparing to enter the medical and healthcare industries by product development using EEG like sleep anesthesia measuring devices and sleep monitoring. Hong ended the interview by saying, “We are trying to expand to areas based on EEG or brain research, From the perspective of a growing company, close communication with customers (buyers, medical staff, etc.) is very important. As for this, Pangyo has the geographical advantage of having mobility. There are many IT and BT companies with technological prowess, and many organizations that support the companies to grow, so we can even go for win-win strategy.”