Brain-Computer Interface Commercialization Breakthrough: Brainwise Leading the Charge, Shanghai Seizes Billion-Dollar Industry Heights

Interface News Reporter | Xu Meihui

Interface News Editor | Wen Shuqi

After four years of high-level paralysis, a patient who suffered a neck spinal cord injury from a car accident and completely lost hand grasping ability wrote the characters “Thank you” with his previously numb hand. This scene actually occurred during a clinical trial of brain-computer interface at a top domestic hospital. Behind it is the implantable brain-computer interface system independently developed by Shanghai Brain-Computer Interface company Borui Kang.

According to the official website of the National Medical Products Administration, recently, Borui Kang Medical Technology (Shanghai) Co., Ltd. received approval for the registration of an innovative product—the implantable brain-computer interface hand motor function compensation system—marking the world’s first launch of a brain-computer interface medical device. This also signifies that the world’s first invasive brain-computer interface medical device has entered the clinical application stage.

This product consists of a brain-computer interface implant, an implantable EEG electrode set, EEG signal transmitter and receiver, pneumatic glove device, disposable surgical kit, EEG decoding software, medical testing software, and clinical management software. It is suitable for patients with quadriplegia caused by cervical spinal cord injury, helping to compensate for hand grasping function via pneumatic gloves. Patients must meet the following conditions: aged 18 to 60, with C2–C6 cervical spinal cord injury rated A–C, diagnosed more than one year ago, with stable condition for at least six months after standardized treatment, unable to grasp with hands, but with some remaining upper arm function. The product uses minimally invasive extradural implantation and wireless energy communication technology. Clinical trial results show that subjects experienced significant improvement in hand grasping ability, thereby enhancing quality of life.

In the domestic brain-computer interface field, Borui Kang is one of the earlier established companies with rapid clinical progress. Founder, Chairman, and General Manager Xu Honglai told Interface News and other media that developing brain-computer interfaces is not about blindly “showing off skills” or purely competing on performance parameters. The company must approach with absolute respect for medical ethics, refining a medical device that is safe, effective, acceptable to patients, and truly capable of solving the bottlenecks in neurological disease diagnosis and treatment.

He also admitted that although obtaining the medical device registration certificate is a milestone indicating the product has passed safety and efficacy tests, he still feels “a lot of pressure.”

“Getting the certificate is just the beginning,” Xu Honglai said. He plans to accelerate hospital adoption, establish standardized usage and rehabilitation procedures, and aim to start clinical application for the first patient within the year.

Behind this leading company’s rapid acceleration reflects a necessary industry logic: Why Shanghai? As a hub for brain-computer interface R&D and industrialization, Shanghai is leveraging forward-looking top-level planning, top clinical resources, and a complete industrial chain to proactively carve out a position in the future trillion-scale industry landscape with strong pragmatism.

A project manager for Shanghai’s brain-computer interface initiative told Interface News that Shanghai has established a bottom-line logic oriented toward final medical products in future industry cultivation, actively safeguarding companies as they connect fundamental R&D, large-scale clinical validation, and registration approval into a full closed-loop process.

Currently, Shanghai has developed the most comprehensive platform capabilities, cutting-edge technological breakthroughs, leading product R&D, professional testing systems, and an active innovation ecosystem, striving to become the global “brain-computer interface innovation hub.”

Overcoming the “Impossible Triangle”

Founded in 2011, Borui Kang’s core team originates from Tsinghua University’s Neural Engineering Laboratory. After more than a decade of accumulation, the company has built a foundational brain-computer interface technology platform centered on neural signal acquisition, analysis, and feedback. Its products have been widely validated by top domestic research and medical institutions in neuroscience research and neurological disease treatment.

Xu Honglai explained to Interface News that around 2019, Borui Kang’s core team decided to enter the field of implantable brain-computer interface systems. This decision meant facing extremely high R&D barriers, long development cycles, and high failure risks.

He recalled that in the engineering of brain-computer interfaces, there is an “impossible triangle”: signals must be transmitted quickly and accurately, surgical trauma must be minimized, and the system must remain safe and stable over the long term inside the human body.

In choosing a technical path, Borui Kang did not blindly pursue the maximum number of channels but opted for epidural implantation. This product form is similar to cochlear implants, with sensors semi-stitched onto the dura mater by surgeons.

Xu explained that clinical feedback indicates this surgical approach has very low risk and effectively avoids sensor displacement within brain tissue, greatly enhancing device safety.

![Image source: Borui Kang]

In terms of product deployment, Borui Kang has now established both non-invasive and minimally invasive platforms.

The non-invasive devices have obtained multiple medical device registration certificates and broken long-standing overseas monopolies. The minimally invasive series, representing industry barriers, is a coin-sized bidirectional closed-loop system embedded in the skull, capable of real-time extraction and feedback of EEG signals, providing new intervention pathways for severe neurological diseases such as epilepsy, complete spinal cord injury, and stroke.

To achieve the transition from R&D to mass production and meet strict medical device regulatory requirements, Borui Kang shifted focus to Shanghai in 2021, investing in building a Class 10,000 cleanroom and a comprehensive quality management system, realizing full-scale production from R&D, testing, to manufacturing.

Xu believes that settling in Shanghai is due to its authoritative advantages in medical device testing and inspection, as well as the government’s high sensitivity and inclusiveness toward cutting-edge technology.

He said that in 2024, when the biopharmaceutical capital market is generally in a downturn, the rapid lead investment by Shanghai Guotou and other municipal state-owned funds provided crucial financial backing for Borui Kang’s large-scale clinical trials.

Government support directly accelerated Borui Kang’s market progress. Public information shows that its latest round, a D+ round scheduled for 2025, includes investors such as Dachen Caizhi and Zhongguancun Development, with a post-investment valuation of 3.5 to 4 billion yuan.

Just last month, the China Securities Regulatory Commission website showed Borui Kang had filed for guidance and registration with the Shanghai Securities Regulatory Bureau on February 4, 2026, planning an initial public offering and listing, with CITIC Securities as the guiding underwriter.

The dual guarantee of capacity and capital has laid a solid foundation for Borui Kang’s clinical push. Currently, its spinal cord injury product (NEO) entered the national innovative medical device channel in August 2024, and its epilepsy product (ANS) entered in March 2025.

Interface News learned that Borui Kang has completed 36 clinical surgeries so far, including 4 feasibility studies, 32 multicenter positive clinical trials, and finished collecting primary clinical endpoints by late November 2025.

Xu revealed that among these 36 patients, the system’s total stable operation time has approached 8,000 days, with the longest implant being nearly two and a half years of stable use.

Entering the Global Top Tier

Beyond Borui Kang’s epidural approach, another Shanghai-based company, Ladder Medical, is exploring deeper into brain tissue with invasive technology. Founded in 2021 by a team from the Chinese Academy of Sciences’ Center for Brain Science and Intelligent Technology, Ladder Medical aims to implant flexible electrodes to precisely record single-neuron activity within a 100-micron range, enabling high-quality wireless decoding of complex movement and consciousness.

Founder Li Xue said, “With deep expertise in electrode materials and system integration, Ladder Medical has completed early clinical validation of three generations of initial systems in 2025 and is actively preparing for larger-scale clinical trials this year.”

When asked about competition with overseas giants like Neuralink, Li Xue told Interface News that domestic companies already have advantages in some core single-point technologies.

She stated that Ladder Medical is at the forefront globally in miniaturizing ultra-flexible neural electrodes, making them ultra-thin and highly biocompatible for long-term use. In terms of system integration and high-channel scalability, they are rapidly iterating to catch up.

This momentum largely stems from national strategic guidance and strong local industrial support. In Shanghai, the industrial chain advantages significantly shorten R&D cycles.

Li Xue believes Shanghai not only has top-tier neuroscience research and abundant clinical resources from leading hospitals but also a complete closed-loop in high-end medical device manufacturing, high-precision chip fabrication, and core component supply chains. This industrial density enables rapid translation of technological breakthroughs into engineering products.

![Image source: TuChong]

Regardless of technological evolution, medical-grade brain-computer interfaces must ultimately be validated in real clinical scenarios.

As the national center for neurological diseases, Huashan Hospital affiliated with Fudan University plays a core role in the domestic clinical ecosystem. Director Mao Ying told Interface News that brain-computer interfaces are not panaceas or hype, “The core goal of clinical research is to genuinely alleviate patient suffering and improve quality of life.”

In Borui Kang’s first trial with the subject “Xiao Dong,” a young patient with high-level paralysis for four years, system assistance not only restored grasping ability but also showed substantial improvement in nerve functions after removing external exoskeletons. Later, he independently wrote “Xiao Dong” and “Thank you” with his affected hand. Additionally, functions like bladder and bowel control, previously lost, also partially recovered. These additional improvements exceeded the initial expectations of the clinical team.

As the technology advances in clinical applications, strict ethical and regulatory boundaries are also established. Mao Ying believes that true brain-computer interfaces must have “closed-loop” and “interactive” features; unidirectional electrical stimulation is only deep brain stimulation (DBS).

As a medical expert repeatedly emphasizing ethical boundaries at the clinical front line, Mao Ying highlighted the dual-edged nature of cutting-edge technology. He told Interface News that to address ethical challenges brought by new technology and to protect patient rights, Shanghai has established a higher-level medical ethics committee for brain-computer interfaces beyond individual hospitals. This committee follows the strictest review procedures and maintains a clear red line: no additional harm to already suffering patients during clinical trials.

Mao Ying pointed out that from a long-term commercialization perspective, issues such as price approval, inclusion in medical insurance, and balancing technology costs with patient affordability remain industry challenges.

He compared brain-computer interface technology to a newly made “hammer”: companies must find clear “nails” (indications) in the real medical market to complete the final business cycle.

Why Can Shanghai Lead the Future Industry?

The wave of brain-computer interfaces is not only a revolutionary leap in human medical technology but also a strategic battleground for major powers to seize global technological high ground and dominate future industries.

At the national top-level design level, the “14th Five-Year Plan” explicitly emphasizes forward-looking layout of future industries, with brain-computer interfaces as a new growth point.

According to McKinsey, the potential global market size for brain-computer interface medical applications could reach $40 billion by 2030 and $145 billion by 2040.

Faced with this clear strategic opportunity and a trillion-yuan industry blue ocean, Shanghai’s industrial planning demonstrates strong pragmatism.

This pragmatism and confidence stem from Shanghai’s solid biopharmaceutical ecosystem. Interface News learned from the Shanghai Municipal Science and Technology Commission that in 2025, Shanghai’s biopharmaceutical industry will grow against the trend, surpassing one trillion yuan for the first time.

Among them, the output value of innovative drug and medical device companies further increased to 20.9%. In terms of going global, the number of overseas licensing transactions reached 48, ranking first nationwide; transaction value reached $33.761 billion, an 85% increase year-on-year, second in the country.

To address the challenges of translating cutting-edge high-tech into clinical practice, Shanghai has been accelerating review and approval processes for innovative drugs and devices, increasing insurance support, promoting commercial health insurance, and demonstrating innovative products.

Through a full-chain approach of “R&D + clinical + manufacturing + application,” combined with comprehensive financial, talent, and data support, Shanghai aims to become the most friendly city globally for innovative drugs and devices, providing fertile ground for high-risk, high-value frontier research from lab to market.

On January 10, 2025, the “Shanghai Brain-Computer Interface Future Industry Cultivation Action Plan (2025–2030)” was officially issued. It emphasizes medical-grade scenarios as the core, with strategic products as the guide, focusing on the implementation of invasive and semi-invasive brain-computer interface technologies and products, while encouraging non-invasive development.

Interface News learned from the Shanghai Municipal Science and Technology Commission that this plan is the first brain-computer interface action plan approved and issued by a provincial-level government in China, and also Shanghai’s first action plan in the future industry subdivision.

![Image source: Shanghai Municipal Science and Technology Commission]

“The logic of looking from 10 to 1 is not exactly the same as from 1 to 10,” said the project manager of Shanghai’s brain-computer interface initiative, revealing the underlying logic of Shanghai’s model.

He explained that unlike some regions still focusing on dispersive basic scientific research, laboratory theory, and single component breakthroughs, Shanghai, when judging that the brain-computer interface industry is on the verge of explosive growth, decisively adopted a resource allocation strategy centered on enterprises and oriented toward final medical products.

This means Shanghai directly targets the most critical link closest to commercialization.

This clear industry orientation is reflected in the efficiency of government-enterprise collaboration. The project manager provided data: when promoting Borui Kang’s 32-sample clinical trials, the company initially estimated it would take over a year. After government intervention and coordination with Huashan Hospital and other clinical resources, the original serial process was optimized into high-intensity parallel work. Ultimately, it took only 78 days to complete patient screening, enrollment, and all surgical procedures across 11 hospitals nationwide.

This “Shanghai speed” of practical implementation greatly shortens the cycle for high-threshold innovative medical devices to reach the market and provides valuable reference for domestic brain-computer interface companies navigating complex clinical and regulatory processes.

Not only individual companies are racing ahead, but across Shanghai, a complete chain covering basic research, key components, standards, clinical translation, and industrialization has taken shape.

Currently, Shanghai has gathered nearly 60 brain-computer interface startups, including pioneers in invasive and semi-invasive tracks like Borui Kang, Brain Tiger Technology, Ladder Medical, and Shen Fuhui Xing, as well as emerging commercial players like Shuyi, Siyie, Aoyi, Quelan, and Niantong, which have achieved revenues of hundreds of millions of yuan in non-invasive rehabilitation and screening fields.

The scale effect of the full technical route is generating landmark achievements: from the world’s first registered implantable brain-computer interface, to the first real-time Chinese language decoding clinical trial, to the first domestic brain-spinal interface IIT trial, multiple technological paths are continuously breaking boundaries.

From the China Brain-Computer Interface Platform led by Lingang Laboratory, to the Shanghai Medical Device Inspection Institute’s testing of over 90% of implantable brain-computer interface products nationwide, to Fudan University-affiliated Huashan Hospital leading the iBRAIN alliance to build a high-quality intracranial EEG database, Shanghai has established a highland of the brain-computer interface industry with “the most comprehensive platform capabilities, the most cutting-edge technological breakthroughs, the most advanced product R&D, the most professional testing systems, and the most active innovation ecosystem.”

As more cutting-edge products enter clinical validation, Shanghai is leading the global brain-computer interface industry with a full technological route, paving a clear path toward commercialization.