Shanghai's First Clinical Trial Implantation of Boruikang's Collaboratively Developed Brain-Computer Interface Product NEO Successfully Completed

Nov 13, 2024 12:42 CST Updated 12:42

Neuracle

Developer and Manufacturer of Brain-Computer Interface Systems and Related Equipment

Recently, Neuracle Medical Technology (Shanghai) Co., Ltd. ("Neuracle" for short) collaborated with Professor Hong Bo's team from the Department of Biomedical Engineering at Tsinghua University to successfully complete the third clinical trial implant surgery in China and the first in Shanghai for their brain-computer interface product NEO at Huashan Hospital. The product completed its research and development as well as type inspection in Shanghai. In August 2024, it became the first brain-computer interface product in China to enter the special review process for innovative medical devices, paving the way for the industrialization of brain-computer interfaces. This implant surgery marks the first human implant procedure for a Neuracle product after entering the innovative special review process. It also utilized self-developed innovative technologies for the first time in collaboration with Huashan Hospital, such as the "Online Temporal-Spatial Brain Function Localization System," which enables rapid and precise localization of hand motor/sensory brain regions without the need to wake the patient during surgery, achieving accurate functional localization implantation.

It is reported that the product is still in the clinical trial stage, and it is expected to obtain a Class III medical device registration certificate after completing multi-center clinical trials. The patient in this surgical case is 38 years old, with cervical spinal cord injury caused by a car accident, unable to grasp with hands or stand, and showed no improvement after four years of rehabilitation. The patient recovered well after the surgery and was able to get out of bed and sit in a wheelchair on the third day.

Neuracle founder Xu Honglai introduced that the smooth progress of Neuracle's clinical trials is inseparable from the support of Shanghai. "The relevant departments in Shanghai have actively promoted our cooperation with top hospitals. Through close collaboration with leading medical institutions, Neuracle has been able to accelerate the validation and optimization of brain-computer interface technology in real clinical applications while driving the rapid transformation of experimental data and research results into clinical efficacy. This model not only shortens the time for technology implementation but also lays a solid foundation for future expanded applications in neurorehabilitation and disease diagnosis and treatment. In addition, due to the lack of mature chip solutions for neural signal acquisition, wireless power supply, and communication in brain-computer interfaces, we are planning to collaborate with top semiconductor design universities and enterprises in Shanghai. We aim to enhance system performance from the ground up, further strengthen the localization capability of key technologies in China, and lay a solid foundation for an efficient and stable brain-computer interface system."

As early as the initial stage, Shanghai actively promoted the development of Neuracle Technology (Shanghai) Co., Ltd.; the rapid and smooth implementation of this clinical trial was also due to Shanghai's active coordination with the Shanghai Medical Device Inspection and Research Institute and Huashan Hospital in conducting type inspections, recruiting clinical patients, and preparing for implant surgeries.

Xu Honglai introduced: "Neuracle has just completed the signing of its D-round financing. Subsequently, our clinical trials will be fully launched, and I believe the advantages of this technical route in commercial prospects will gradually become evident." In Xu Honglai's view, Shanghai not only provides rich clinical application scenarios for technology enterprises' R&D but also brings numerous opportunities for the transformation of scientific research achievements through its deep industry-academia-medical-research collaboration ecosystem.

It is reported that Neuracle is currently developing higher-density and higher-throughput electrodes to cover a wider range of brain functional areas, decoding fine motor skills and language, among others. In the future, Neuracle's related system products will not only help patients complete basic movements, such as eating and drinking, but may even assist them in performing delicate motor control tasks like writing and playing musical instruments.

In recent years, to accelerate the cultivation of future industries, Shanghai has been actively promoting cutting-edge technological innovation in brain-computer interfaces, incubating and establishing innovative companies such as Neuracle, BrainCo, and StepMed. These companies have developed products in invasive and semi-invasive fields respectively. "Neuracle has been deeply involved in the brain-computer interface field for many years. As a leading enterprise in the brain-computer interface industry, Neuracle has advanced from non-invasive technology to semi-invasive technology at the technical level; and expanded from brain science research to clinical diagnosis, treatment, and rehabilitation at the product level. Over the past two years, Neuracle has made significant breakthroughs in both sales and R&D, especially achieving a major 'from 0 to 1' breakthrough in human trials with minimally invasive brain-computer interface clinical progress, obtaining positive clinical results. It has also passed the special review for innovative medical devices, confirming that the 'minimally invasive implantation' solution is a safe and effective technical route."

Source: Shanghai Technology

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