On May 18, China officially launched its first multi-center clinical trial for a 128-channel fully implantable brain-computer interface (BCI) system. The trial, led by Beijing Tiantan Hospital affiliated with Capital Medical University, marks a significant acceleration in the clinical translation of domestically developed fully invasive BCI technology. This development offers new hope for rehabilitation in patients with quadriplegia.
The invasive BCI system used in this research consists of two main modules: an intracortical implantable flexible electrode and a highly integrated fully implantable signal acquisition device. The flexible electrode, made of ultra-thin biocompatible materials, significantly reduces post-implantation immune reactions. It precisely captures single-neuron action potentials with high spatiotemporal resolution, enabling the system to decode intricate brain electrical information in real-time with high precision. This capability leads to an order-of-magnitude leap in the information transmission rate for human-computer interaction. The accompanying fully implantable signal acquisition device features a wireless, fully embedded design. It incorporates a medical-grade rechargeable battery supporting wireless charging and can simultaneously collect and transmit high-channel neural signals. This allows patients to receive treatment and rehabilitation training in a more natural and comfortable environment, truly meeting the convenience and safety requirements for clinical application.
The clinical trial plans to enroll 32 participants, all of whom are patients with quadriplegia resulting from spinal cord injuries. Currently, 11 medical institutions have joined the study, with all patient enrollments expected to be completed within six months. Post-surgery, patients will undergo a recovery period of approximately one month to allow the implanted electrodes and the brain to adapt. The official activation time of the system is not fixed and will vary individually based on the patient's adaptation process. Once the system begins operation, patients will undergo about two months of training to achieve personalized optimization of brain electrical signals. According to trial expectations, patients will first be able to achieve brain-controlled cursor movement and initiate hand movements with the aid of assistive training devices.
Furthermore, patients will be observed for 180 days post-operation to assess various factors including electrode effectiveness, resistance changes, neurological function recovery, and psychological scales. The research team aims to complete the validation of the safety and efficacy of the 128-channel system. This clinical trial will accumulate crucial data for higher-order BCI technologies. The research team plans to initiate clinical trials for a next-generation system with a higher channel count within the next two years. By then, the electrodes are expected to cover multiple functional areas of the brain, potentially enabling motor assistance for more limb parts such as arms and lower limbs, thereby advancing BCI technology from single-point functional rehabilitation towards the reconstruction of full-body motor functions.
On April 1, the Beijing Fourth Wave Technology Think Tank and the Zhongguancun Tiancheng Innovation Research Center jointly released the "China Brain-Computer Interface Commercialization Prospect Report." The report indicates that, driven by the combined forces of supportive industrial policies, technological breakthroughs, and emerging market demand, BCI technology is expected to enter a "golden window period" for large-scale commercial implementation. The year 2026 is projected to be the inaugural year for the scaled application of BCI. China's BCI market size is anticipated to exceed 5 billion yuan by 2026 and maintain rapid growth, with the market scale expected to surpass 15 billion yuan by 2030.
The aforementioned report mentions that companies represented by BrainRobotics, Boric, and Stepladder Medical have already accumulated substantial case experience in clinical trials. Some semi-invasive and flexible invasive products have entered the "Innovative Medical Device" green channel of the National Medical Products Administration and are expected to receive formal market approval between 2026 and 2027. Researchers stated this signifies that invasive BCI is on the verge of transitioning from "research prototypes" to billable medical devices, with the commercial loop about to be completed.
Analysts note that BCI has been upgraded to a strategic industry in China's 15th Five-Year Plan. With strong multi-faceted policy support, the industry's implementation is expected to accelerate, highlighting the importance of investment opportunities. BCI is both a medical and a technology industry. In the short term, its primary application lies in disease treatment. In the long term, if it can achieve human enhancement and integrate with AI and robotics, it has the potential to unlock a trillion-yuan market. There is no inherent superiority between non-invasive and invasive BCI interfaces; the focus should be on identifying "true BCI" applications that have genuine demand and align with national policy support.
Related Concept Stocks: MICROPORT NEURO (02172): Public information shows that MicroPort Neuro's product portfolio comprehensively covers hemorrhagic stroke, atherosclerotic stenosis, and acute ischemic stroke. According to Frost & Sullivan statistics, based on 2023 sales revenue, MicroPort Neuro has risen to become the fourth-largest player in China's neurointerventional medical device market share, maintaining its position as the top domestic brand in recent years.
HEARTCARE-B (06609): In 2021, HeartCare-B began collaborating with Nankai University to initiate an invasive BCI project. Multiple animal experiments have been completed, theoretical verification has concluded, and formal clinical trials are expected to commence before the end of 2026.
NANJING PANDA (00553): The company is undertaking the project "Research and Development of Key Technologies for the Integration of Multimodal Human-Computer Interaction Systems Based on Brain-Computer Interface Technology," which is a subject within the Jiangsu Provincial Key R&D Program. Currently, the company is progressing according to plan, having completed the development of a brain-controlled intelligent interaction terminal, optimized and iterated the interaction system, and initiated patent applications and standard formulation work.
LENS (06613): LENS's experience in mass-producing millions of units for the BrainCo project represents a globally scarce asset. As one of the very few major players to have successfully navigated the BCI hardware manufacturing process, the company has established significant process barriers. In the future, leveraging this first-mover advantage, the company is poised to potentially enter the global supply chain of international giants like Neuralink, becoming an indispensable hardware infrastructure provider in the era of "brain-computer interconnection."
Comments