
Innovative Medical Device Solution Provider
Author |Genlight
6Month2Day, Brain-Computer Interface CompanyNeuralinkOfficial Announcement: Genlight Neurotech's Brain Implant Device Enters Clinical Trial Phase and Raises Funds in the Latest Round of Financing6.5Billion US dollars.
NeuralinkWas founded by Musk in2016Founded in the year, a brain-computer interface company that has already launched clinical trials of brain-computer interface devices in the United States, Canada, the Middle East, and other regions.
According to official reports, five patients with severe paralysis have undergone brain-computer interface device implantation surgery, transmitting neural signals through chips implanted in the brain.
Musk's team is still in the clinical trial stage in the research of brain-computer interface, and it is still a long way from obtaining approval in the United States.FDARegistration certificate, widely used in the medical field, still has a long way to go.
However, the research on brain-computer interfaces does not only stay atNeuralink, which has now become a global topic. Recently, we visited a brain-computer interface research team in Hangzhou, Zhejiang, China: Genlight Neurotech.
According to Genlight Neurotech Founder andCEOCao Peng told us,“Currently, Genlight NeurotechBrain-Computer Interface DeviceEpilcureAlready completed100Clinical Trial Example, and will soon submit a certification registration application to the National Medical Products Administration (NMPA),Expected to obtain medical certification next year。”
2024Year10Month,60Mr. Jin, aged [age], accidentally fell during a roof operation, resulting in a burst fracture of the thoracic vertebrae. In the subsequent medical treatment, Mr. Jin was diagnosed with complete spinal cord injury, which means he has completely lost the ability to walk and may only be able to go out with the help of a wheelchair in the coming days.
At that time, Zhejiang University and GenLight were jointly conducting a medical research project on a closed-loop neural interface. The goal of this medical research project was to help patients who had lost lower limb motor function to walk again through brain-computer interface technology, using a system called the closed-loop spinal cord neural interface system.
After learning about this project, Mr. Jin's daughter placed her hopes on this cutting-edge technology and enrolled her father in the clinical trial.
One year later, with the participation of Genlight Neurotech, the Second Affiliated Hospital of Zhejiang University School of Medicine, Nanhu Brain-Computer Interface Research Institute, the National Key Laboratory of Brain-Computer Intelligence, and the College of Biomedical Engineering and Instrument Science, China's first closed-loop spinal cord neural interface implant surgery was completed in Hangzhou. As a beneficiary of this clinical trial, Mr. Jin stood up again.
We recently visited the office of Genlight Neurotech (Hangzhou) and met with its founder and...CEOCao Peng told us:
“During the initial treatment process, this patient first underwent rehabilitation training. After the rehabilitation training, the patient was able to slightly lift their leg while lying in bed, but was still unable to move.
Subsequently, the patient completed‘Closed-loop Spinal Cord Neural InterfaceAfter the implant surgery, through neural decoding and electrical stimulation, the patient was eventually able to achieve independent standing and walking.。”
So, how did the brain-computer interface technology work on this patient?
In this regard, Cao Peng explained to us that brain-computer interface technology is divided into three steps throughout the treatment process:
Step 1,Signal Acquisition, collecting electromyographic feedback signals through sensing devices;
Step Two,Signal Decoding and Analysis, decode these collected signals to understand the patient's movement intentions such as leg lifting and walking;
Step Three,Signal Transmission, transmitting the nerve signals that were originally unable to reach the corresponding tissues in the legs due to spinal cord injury, thereby enabling the leg nerves, muscles, and bones to coordinate movement and complete motion actions.
Cao Peng told us,“These three steps are actually the basic working principles that are universally applicable in the treatment of other diseases using brain-computer interface technology. The difficulty lies in,At present, people's exploration and understanding of the nervous system are still not deep enough. For example, which nerve controls which movement, and what signal threshold is required for precise movement control, all need further research.。”
In fact, Genlight Neurotech is already leveraging brain-computer interface technology to tackle the treatment of challenging diseases such as epilepsy, Parkinson's disease, and ALS, particularly through its implantable closed-loop neuromodulation system that has been under research for many years.EpilcureAlready completed100Example Clinical Trial: A New Device for Epilepsy Treatment is Underway.
According to the World Health Organization2024The statistical data of the year shows,Globally, there are approximately5000Epilepsy has become one of the most common neurological disorders globally, with tens of millions of patients.。
Among these, there is70%Patients can achieve control by taking medication, leaving30%Patients whose seizures are difficult to control through medication, namely those with drug-resistant epilepsy, usually require surgical treatment. However, if the lesion is located in a functional area of the brain, conventional surgical resection carries significant risks.
It is precisely because of the high prevalence and complexity of such diseases that epilepsy has become an important area of global brain science research, and also a disease case that most brain-computer interface technology research teams first study when entering the medical field.
The development of such a fully implantable medical-grade product for the human brain is no easy task. Cao Peng summarized the difficulties of this work into three aspects:
First,Microsignal Processing, the acquisition of tiny signals from cranial nerves, anti-interference processing, and the clear reading of these tiny signals;
Second,Software Algorithm Development, the chip implanted in the brain struggles to carry the epilepsy detection algorithm; relatively complex computations or algorithm updates still require wireless communication and real-time interaction with external devices to resolve;
Third,Hardware Chip DevelopmentThe chip implanted in the brain is equivalent to a miniature computer, which needs to complete the entire process of sensing, computing, controlling, and outputting neural signals. The chip implanted in the brain has extremely strict requirements for power consumption and heat dissipation, posing high demands on chip development.
In order to overcome these technical challenges, Genlight Neurotech has joined forces with Xuanwu Hospital of Capital Medical University, Huashan Hospital Affiliated to Fudan University, and the Second Affiliated Hospital of Zhejiang University School of Medicine.EpilcureCarried out project research and development, and in2021Year3Monthly application has been used in the first clinical implant surgery in Asia.
It is reported that, as a fully implantable brain-computer interface product, during use,EpilcureThe computing unit will be implanted into the patient's brain to continuously monitor abnormal brain signals that may trigger epileptic seizures, and once abnormal signals are detected, it will block and intervene.
According to Cao Peng,“To this day,EpilcureAlready completed100Example of clinical implant surgery: After the device is implanted, it can detect abnormal brain signals as soon as they appear.”
In addition, Cao Peng also pointed out,“This product has completed patient enrollment in clinical trials and is planned to submit a certification registration application to the National Medical Products Administration this year. It is expected to obtain medical certification next year, becoming the first commercially applicable brain-computer interface product in China.”
However,EpilcureJust Genlight NeurotechStrideThe first step towards commercialization, Genlight Neurotech has greater ambitions in the brain-computer interface field.
In cooperation withDuring the conversation with Cao Peng, we found that the development of brain-computer interface technology and artificial intelligence technology has many similarities, such as being data-driven.
Big data and powerful computing capabilities have led to the continuous iteration of large models today, and brain-computer interface technology research similarly requires a foundation of extensive sample data.
According to Cao Peng,“Genlight Neurotech has currently accumulated hundreds of thousands of labeled data in the epilepsy field, and these data will be utilized in the future throughAIAfter the model analysis, aAIModel, based onAIChip implanted into the brain。”
This is the technological advantage of Genlight Neurotech, as well as the R&D concept for their next-generation products.
However, for Genlight Neurotech at present, the real advantage lies in their construction of aUniversal Closed-Loop Neural Interface Technology Platform。
Since the basic principle of treating various brain and nervous system diseases through brain-computer interface technology is the same, all requiring the process of signal acquisition, decoding analysis, control, and feedback, Genlight Neurotech has constructed a universal closed-loop neural interface technology platform.
It is reported that the aforementioned treatment for paraplegiaClosed-loop spinal cord neural interfaceSystem, for the treatment of epilepsyEpilcure, as well as Genlight Neurotech's treatment for Parkinson's diseaseiSBS, are all developed based on this platform.
It was after completing the entire set of brain-computer interface research and development systems and product system construction for the medical field that Cao Peng told us,“2025The year will be the brain-computer interface epoch of Genlight Neurotech.。”
Cao Peng believes that2025This year marks the first year of GenLight's brain-computer interface (BCI) development. On one hand, GenLight will complete clinical enrollment for its first indication, drug-resistant epilepsy, with its closed-loop BCI regulation product and submit a registration application to the National Medical Products Administration (NMPA). On the other hand, GenLight also plans to expand the application of BCI technology into other fields in the future.
Regarding this“Plan”Specifically, Cao Peng revealed to us,“The largest application field is to collaborate with embodied intelligence robotics teams, applying brain-computer interface technology to scenarios such as health care and home use.。”
As for when such embodied intelligence technology will enter households, Cao Peng believes,“5-10Within a year, such embodied intelligent robots will enter households to help you pour water, cook, and wash clothes. This time point will actually arrive very soon.。”