Breakthrough in Commercialization of Brain-Computer Interfaces: BoRay Neurotech Leads the Way as Shanghai Captures a Trillion-Yuan Industry Frontier

Four years after suffering a high-level spinal cord injury, a patient who lost all hand grip function due to a car accident that damaged the cervical spine was able to write the words "thank you" with a previously paralyzed hand. This remarkable moment occurred during a brain-computer interface clinical trial at one of China’s top hospitals. Behind this breakthrough is an implantable brain-computer interface system independently developed by Neuracle Technology (Shanghai) Co., Ltd.

According to the official website of the National Medical Products Administration, recently, the National Medical Products Administration approved the innovative product registration application of Neuracle Technology (Shanghai) Co., Ltd. for its implantable brain-computer interface hand motor function compensation system, marking the world's first market launch of a brain-computer interface medical device. This 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 kit, an EEG signal transceiver, a pneumatic glove device, a disposable surgical tool kit, EEG decoding software, medical testing software, and clinical management software. It is suitable for patients with quadriplegia caused by cervical spinal cord injury, assisting in compensating for hand grasping function through the pneumatic glove device. Patients must meet the following criteria: aged 18 to 60, with C2-C6 cervical spinal cord injury rated A-C level quadriplegia, diagnosed for over one year, with stable condition for at least six months after standardized treatment, unable to perform hand grasping, but retaining partial upper arm function. The product employs epidural minimally invasive implantation and wireless power supply communication technology. Clinical trial results show that users significantly improved their hand grasping ability through this product, thereby enhancing their quality of life.

In China's brain-computer interface field, Neuracle is one of the earlier-established companies with relatively rapid clinical progress. Xu Honglai, founder, chairman, and general manager of Neuracle, stated in an interview with media outlets including The Paper that developing brain-computer interfaces is not about blindly "showing off skills" or simply competing on performance parameters. Companies must approach this with absolute respect for medical and ethical considerations, refining a medical device that is sufficiently safe, effective, acceptable to patients, and truly capable of addressing bottlenecks in the diagnosis and treatment of neurological diseases.

He also admitted that although obtaining the medical device registration certificate is a landmark milestone, which means the product has been proven in terms of safety and effectiveness, he still feels "under great pressure."

"Obtaining the certification is just the beginning," said Xu Honglai, who added that subsequent efforts will focus on accelerating the product's adoption in hospitals, establishing standardized usage and rehabilitation procedures, and striving to achieve the first clinical application for a patient within the year.

Behind the rapid acceleration of this leading company lies an inevitable industrial logic: Why Shanghai? As a key hub for brain-computer interface research and industrialization, Shanghai is leveraging forward-thinking top-level planning, top-tier clinical resources, and a complete industrial chain to make a strategic move on the map of a future industry worth hundreds of billions with strong pragmatism.

The project manager of the Brain-Computer Interface Project in Shanghai told the reporter of The Paper that Shanghai has established a bottom-line logic oriented towards final medical products in cultivating future industries, and is substantially supporting enterprises to打通 the entire chain from underlying research and development, large-scale and large-sample clinical verification, to registration and approval.

Currently, Shanghai has formed the most comprehensive platform capabilities, the most cutting-edge technological breakthroughs, the most advanced product development, the most professional testing systems, and the most dynamic innovation ecosystem. It is now fully committed to becoming the world's "primary source of brain-computer interface innovation."

Founded in 2011, Neuracle's core team originated from the Neural Engineering Laboratory at Tsinghua University. After more than a decade of development, 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 research institutions and medical facilities in China for brain science studies and the diagnosis and treatment of various neurological disorders.

Xu Honglai introduced to the Jiemian News reporter that around 2019, Neuracle's core team decided to venture into the implantable brain-computer interface system. This decision meant facing extremely high R&D barriers, long cycles, and high failure risks.

Xu Honglai recalled that there is an "impossible triangle" in brain-computer interface system engineering: signal transmission must be fast and precise, surgical trauma must be minimized, and the system must remain safe and stable in the human body over the long term.

In terms of technical path selection, Neuracle did not blindly pursue the ultimate number of channels but instead opted for epidural implantation. This product form is similar to a cochlear implant, with surgeons using threads to semi-suture the sensor onto the epidural space.

According to Xu Honglai, feedback from clinicians indicates that this procedure carries extremely low surgical risks and effectively avoids the risk of sensor displacement within brain tissue, significantly enhancing the safety of the device.

In terms of specific product layout, Neuracle has successfully established both non-invasive and minimally invasive platforms.

Among them, the non-invasive devices have obtained multiple medical device registration certificates and broken the long-term monopoly overseas. The minimally invasive series, which represents the industry barrier, is a coin-sized bidirectional closed-loop system buried in the skull to extract and feedback brain electrical information in real time, providing a new intervention pathway for major neurological diseases such as epilepsy, complete spinal cord injury, and stroke.

To achieve the leap from research and development to mass production and meet the stringent regulatory requirements for medical devices, Neuracle shifted its focus to Shanghai in 2021. It invested heavily in building a Class 10,000 cleanroom and a complete production quality management system, fully implementing capabilities from R&D, testing, to manufacturing.

In Xu Honglai's view, choosing to settle in Shanghai is precisely because of Shanghai's absolute authoritative advantage in the inspection and testing of innovative medical devices, as well as the government's high sensitivity and inclusiveness towards cutting-edge technology.

He stated that during the overall downturn of the biopharmaceutical capital market in 2024, the rapid lead investment by municipal state-owned entities such as Shanghai Guotou provided crucial financial backing for Neuracle's subsequent large-scale clinical trials.

Strong support from government state-owned assets has directly triggered Neuracle's acceleration in the capital market. Public information shows that its latest round was the D+ funding completed in 2025, with investors including Fortune Venture Capital, Zhongguancun Development, and others. The post-investment valuation reached 3.5 to 4 billion yuan.

Last month, the website of the CSRC showed that Neuracle Technology (Shanghai) Co., Ltd. had completed the registration for tutoring and filing with the Shanghai Regulatory Bureau on February 4, 2026. It plans to make its initial public offering and list its shares. The tutoring broker is CITIC Securities.

The dual guarantees of production capacity implementation and capital supply have provided a solid foundation for Neuracle's push in the clinical sector. Currently, Neuracle's spinal cord injury indication product (NEO product) entered China's National Innovative Medical Device Channel in August 2024, and its epilepsy indication product (ANS product) entered the same channel in March 2025.

Interface News learned that, as of now, Neuracle has completed 36 clinical surgeries, including 4 feasibility clinical cases and 32 multi-center validation clinical cases, and will complete the collection of primary clinical endpoints by the end of November 2025.

Xu Honglai revealed that among these 36 patients, the system has accumulated nearly 8,000 days of stable operation, with the longest implanted patient having used it stably for almost two and a half years.

Apart from the epidural route represented by Neuracle, Stepping Medical, also based in Shanghai, is exploring an invasive technical route that delves deeper into brain tissue. Founded in 2021, the core team of Stepping Medical originates from the Center for Excellence in Brain Science and Intelligence Technology of the Chinese Academy of Sciences.

"By implanting flexible electrodes, we are able to precisely capture the 'voice' of individual neurons within a 100-micron range, thereby obtaining high-quality single-neuron wireless data necessary for decoding highly complex movements and consciousness," said Li Xue, founder of StairMed.

With its strong accumulation in electrode materials and system integration, Ladder Medical has successfully completed three early clinical validations of the first-generation system in 2025, and is actively preparing to officially launch a larger-scale clinical trial this year.

When discussing the horizontal competition with overseas industry giant Neuralink, Li Xue told reporters from The Paper that Chinese companies already have a comparative advantage in some core single-point technologies.

She stated that Neuracle has reached a globally leading level in the miniaturization, extreme lightness and thinness, and long-term biocompatibility of ultra-flexible neural electrodes. Meanwhile, in terms of system integration and large-scale production with an extremely high number of channels, they are currently making rapid engineering iterations to catch up.

This catching-up confidence largely stems from the tone-setting of national macro strategies and the strong support of local industrial ecosystems. Focusing on Shanghai, the advantages of the industrial chain have significantly shortened the R&D cycle for enterprises.

In Li Xue's view, Shanghai not only boasts top-tier fundamental neuroscience research and abundant clinical resources from leading tertiary hospitals, but also forms a complete closed loop in the advanced processing and manufacturing of high-end medical devices, high-precision chip prototyping, and the supply chain of core components. This industrial concentration allows breakthroughs in cutting-edge foundational technologies to be rapidly transformed into engineering products.

Regardless of how the technical pathways evolve, medical-grade brain-computer interfaces must ultimately be tested in real clinical medicine scenarios.

As the National Center for Neurological Diseases, Huashan Hospital Affiliated with Fudan University plays a core role in the clinical ecosystem of brain-computer interfaces in China. Mao Ying, the president of Huashan Hospital, stated frankly in an interview with Interface News that brain-computer interfaces are not a panacea or a result of hype in technology. "The core goal of clinical research is to genuinely alleviate patients' suffering and improve their quality of life."

In the trial of Neuracle's first subject, "Xiao Dong," a young patient who had been paralyzed from the neck down for four years, not only regained the ability to grasp under the assistance of the system, but also experienced substantial improvement in hand nerve function after removing the exoskeleton brace. In the later stages of the trial, he independently wrote the words "Xiao Dong" and "Thank you" with his affected hand. Additionally, the patient’s previously lost neurological functions, such as bowel and bladder control, showed partial improvement. This additional functional recovery far exceeded the initial expectations of the clinical team.

As technology becomes more deeply integrated into clinical practice, medical ethics and regulatory red lines have been strictly established. Mao Ying believes that, in the strict sense, brain-computer interfaces must possess "closed-loop" and "interactive" properties; one-way electrical stimulation can only be referred to as deep brain stimulation (DBS).

As a medical expert who repeatedly emphasizes the "ethical bottom line" on the clinical front line, Mao Ying particularly underscored the double-edged sword effect of cutting-edge technologies. In an interview with Interface News, he pointed out that, in order to address the ethical challenges posed by new technologies and ensure the highest rights of trial participants, Shanghai has gone beyond the limitations of single hospitals and established a higher-level medical ethics committee at the municipal level specifically for brain-computer interfaces. This committee adheres to the most rigorous review procedures and upholds an absolute red line: no clinical trial is allowed to cause additional harm to patients who are already suffering.

Mao Ying pointed out to the Interface News reporter that, from the perspective of long-term commercialization, overcoming challenges such as gaining approval for pricing, entering the medical insurance payment system, and finding a balance between technical costs and patients' ability to pay remains difficult for the industry.

He compared brain-computer interface technology to a newly forged "hammer," stating that companies must find specific "nails" (indications) in the real medical market to complete the ultimate commercial closed loop.

The wave of brain-computer interfaces is not only a groundbreaking breakthrough in human medical technology but also a strategic battleground for major powers to seize the commanding heights of global technology and the leading role in future industries.

At the national top-level design level, the "15th Five-Year Plan" has clearly proposed to proactively lay out future industries, with brain-computer interface being prioritized as a new economic growth point.

According to McKinsey's forecast, the potential market size of global brain-computer interface medical applications is expected to reach 40 billion US dollars by 2030, and is projected to reach 145 billion US dollars by 2040.

In the face of this clear strategic opportunity and a billion-level industry blue ocean, Shanghai's industrial planning has demonstrated extremely strong pragmatism.

This pragmatism and confidence stem from the robust ecological foundation of Shanghai's biopharmaceuticals industry. According to the Shanghai Science and Technology Commission, the scale of Shanghai's biopharmaceuticals industry achieved counter-cyclical growth in 2025, surpassing the trillion-yuan mark for the first time.

Among them, the output value of innovative pharmaceutical and device companies increased to 20.9%. In terms of international outreach, the number of overseas licensing deals reached 48 throughout the year, ranking first in China; the total transaction value reached $33.761 billion, a year-on-year increase of 85%, ranking second in China.

To address the challenges of implementing cutting-edge hard technologies within the healthcare system, Shanghai has been continuously promoting the acceleration of review and approval processes for innovative drugs and medical devices, as well as their adoption in hospitals. Efforts also include enhancing medical insurance support for innovative drugs and devices, advancing the development of commercial health insurance, speeding up the application and demonstration of innovative products, and actively promoting the coordinated development of healthcare, medical insurance, and pharmaceuticals.

By adopting a full-chain approach of "R&D + clinical + manufacturing + application," coupled with comprehensive support from various innovative elements such as financial, talent, and data empowerment, Shanghai is committed to building the world's most innovation-friendly city for pharmaceuticals and medical devices. This provides fertile ground for high-risk, high-value fundamental frontier research to transition from the laboratory to commercialization.

On January 10, 2025, the "Shanghai Brain-Computer Interface Future Industry Cultivation Action Plan (2025-2030)" was officially released. The plan clearly focuses on medical-grade scenarios as the core, with strategic products as the guide, prioritizing the implementation and application of invasive and semi-invasive brain-computer interface technologies and products, while encouraging the development of non-invasive approaches.

The reporter of The Paper learned from the Shanghai Science and Technology Commission that this plan is the first brain-computer interface action plan in China to be reviewed and released by a provincial government, as well as the first action plan for a细分领域 of Shanghai's future industry.

"Looking from 10 to 1 and looking from 1 to 10, the logic of the two is not entirely the same." The project manager of the Shanghai Brain-Computer Interface explained the underlying logic of the Shanghai model in an interview with Jiemian News.

He introduced that, unlike some regions which still focus on divergent basic scientific research, laboratory theoretical deduction, and single-component breakthroughs in industrial policies, Shanghai decisively adopted a precise resource allocation logic of "enterprise as the core innovation entity and final medical products as the orientation" when it determined that the brain-computer interface industry had reached a historical juncture on the eve of an explosion.

This also means that Shanghai has directly targeted the core环节 closest to commercialization.

This clear industry orientation is directly reflected in the execution efficiency of government-enterprise collaboration. The project manager provided a set of data to the Interface News reporter: When promoting Neuracle to conduct a clinical trial with 32 samples, the company originally planned to take more than a year to complete it. After the government task force actively intervened and coordinated clinical resources such as Huashan Hospital, the original sequential workflow was optimized into high-intensity parallel processing. In the end, it only took 78 days to complete patient screening, enrollment, and all surgical procedures across 11 hospitals in China.

This "Shanghai Speed" of substantive implementation has significantly compressed the cycle for high-barrier innovative medical devices to reach the market, while also providing practical reference for domestic brain-computer interface companies navigating complex clinical and compliance processes.

It is not just the rapid development of individual companies; looking at the broader picture in Shanghai, a complete chain covering basic research, key components, standard setting, clinical translation, and industrialization has already taken shape.

Currently, Shanghai has gathered nearly 60 brain-computer interface startups, including not only pioneers in the invasive and semi-invasive fields such as Neuracle, BrainCo, Stairway Medical, and Restorative Motion, but also emerging commercial players like Surinno, Siyi, Aowill, Quanlan, and Niantong, which have achieved tens of millions in revenue in the non-invasive rehabilitation and screening sectors.

The scale effect of the full technical route is giving rise to a number of landmark achievements: from the world's first registered certificate for an implantable brain-computer interface, to the world’s first prospective clinical trial for real-time decoding of the Chinese language, and further to China’s first Brain-Spinal Interface IIT trial. Multiple technical pathways are continuously breaking boundaries.

From the brain-computer interface platform project led by the Lingang Laboratory, to the Shanghai Medical Device Inspection and Research Institute conducting type inspections for over 90% of China's implantable brain-computer interface products, to the iBRAIN Alliance established by Huashan Hospital Affiliated with Fudan University leading the construction of a high-quality intracranial EEG database, Shanghai has built a brain-computer interface industry hub integrating "the most comprehensive platform capabilities, the most cutting-edge technological breakthroughs, the most advanced product development, the most specialized testing system, and the most dynamic innovation ecosystem."

As more cutting-edge products enter the clinical validation phase, Shanghai is emerging as the world's first innovation hub for full-route brain-computer interface technologies in this high-barrier future industry track, charting a clear path for commercialization.