China is gearing up for extensive clinical trials of its domestically developed brain-computer interface (BCI) device, Neural Electronic Opportunity (NEO), marking a significant step towards regulatory approval and market release. The trials, scheduled to commence next year, aim to recruit 30 to 50 patients with spinal cord injuries across approximately 10 medical centers nationwide.
The NEO implant is a collaborative effort between Shanghai Neuracle Medical Technology Co., Ltd. and a team led by Hong Bo at Tsinghua University’s biomedical engineering department. This year, three human implantation surgeries have already been successfully completed, including one performed at Huashan Hospital affiliated with Fudan University.
Successful Implantation Demonstrations
One notable case involved a 38-year-old patient in Shanghai who had been paralyzed for four years following a car accident. According to Mao Ying, director of Huashan Hospital, the patient was able to get out of bed and sit in a wheelchair just three days after the surgery. Furthermore, the patient has regained the ability to use mind control to move their arms and perform simple actions, such as drinking from a cup.
Mao Ying also noted the efficiency and standardization of the BCI implantation procedure. The surgery on the paralyzed patient took just over an hour, approximately half the time required for the previous two patients. During the procedure, a coin-sized BCI device was precisely implanted into the motor-sensory region of the brain, successfully capturing neural signals.
Regulatory Pathway and Future Applications
NEO completed its development and type testing in Shanghai and, in August, became the first BCI product in China to enter a Special Review Procedure for Innovative Medical Devices of the National Medical Products Administration. The clinical data from the upcoming trials will be crucial for seeking commercialization approval.
Doctors believe that the advancement of BCI technology holds immense potential for patients with neurological impairments, including those with stroke, to regain basic life abilities. The technology can be personalized and optimized for patients of different age groups, with early intervention and rehabilitation training expected to restore a higher quality of life and improve social abilities, especially for younger patients.
Government Support and Industry Growth
The Chinese government has unveiled guidelines to support the technological innovation, industrial cultivation, and safety governance of future industries, including the BCI industry. According to a report by the China Academy of Information and Communications Technology, medical treatment is the predominant application domain for BCI technology in China.
"Achieving efficient information transfer through the remodeling of neural networks is not only key to understanding brain function but also an important approach for developing new therapeutic methods," said Poo Muming, an academician of the Chinese Academy of Sciences.
