The Zhitong Finance App learned that Shanghai Securities released a research report saying that the country's first non-invasive brain-computer interface clinical research project completed the filing of Order No. 818, marking that China's cutting-edge non-invasive brain-computer interface technology has officially entered a new stage of standardized clinical research, which is a landmark. The bank believes that brain-computer interfaces have gradually achieved a key leap from laboratory concept verification to clinical transformation and industrialization implementation. The racetrack continues to show a trend of “policy addition+technological breakthrough+capital inflow”, and multiple factors have enabled industrial development to enter the fast track.
The main views of Shanghai Securities are as follows:
The country's first non-invasive brain-computer interface clinical research project completed the filing of Order No. 818
On November 5, the “Exploration Study on the Safety and Feasibility of SCS Joint Non-invasive Brain Control Hybrid Exoskeleton Training for Chronic Stroke” project, developed by the Tianjin University Brain-Computer Interaction and Human-Computer Integration Haihe Laboratory team and relied on the Tianjin Huanhu Hospital to conduct clinical trials, officially completed the National Health and Health Commission's new biomedical technology clinical research record (State Council Order No. 818).
This is the first non-invasive brain-computer interface clinical research project to be registered in the country since the “Regulations on the Administration of Clinical Research and Translational Application of New Biomedical Technologies” came into effect in May 2026. It marks the official entry of cutting-edge non-invasive brain-computer interface technology in China into a new stage of standardized clinical research, which is a landmark. The core equipment used in the project was for the Brain-Computer Haihe Laboratory team to take the lead in developing the world's first brain-computer-spine-body high-performance complex neuromodulation and rehabilitation system “Shengong-Shenchi”, which is mainly used for neurological rehabilitation intervention treatment for patients with lower limb movement disorder in chronic stroke.
Shanghai issued the “Shanghai Fifteenth Five-Year Plan” to ensure drug safety and promote high-quality development of the pharmaceutical industry to continue improving the brain-computer interface policy package
On November 9, the Shanghai Food and Drug Safety Commission issued the “Shanghai Fifteenth Five-Year Plan to Ensure Drug Safety and Promote High-Quality Development of the Pharmaceutical Industry” (hereinafter referred to as the “Plan”). In the “Frontier Circuit Service and Supervisory Capability Enhancement Actions” column, the “Plan” mentions strengthening the service and supervision of the entire chain of brain-computer interface medical devices. Improve the pre-marketing supervision system for brain-computer interface medical devices, improve the special standard system for brain-computer interface medical devices, and develop evaluation methods and test and evaluation tools for new functions and characteristics of micro-nano neural electrodes. Establish and improve a “research, inspection and supervision” linkage mechanism, explore the linkage between review and approval, inspection and post-marketing risk monitoring, and accelerate product launch and application.
Brain-computer interface company Ladder Healthcare launched IPO counseling and filing, with a cumulative financing of 2.6 billion yuan
Recently, Shanghai Ladder Medical Technology Co., Ltd. (“Ladder Healthcare” for short) has applied for an initial public offering of shares and listing guidance and filing. The consulting agency is Huatai United Securities, and the filing site is the Shanghai Securities Regulatory Bureau.
Established in August 2021 and headquartered in Pudong New Area, Shanghai, Step Medical is a high-tech enterprise focusing on the field of minimally invasive implantable brain-computer interface (BMI). Based on ultra-flexible neural electrode technology, the company is committed to brain-computer interface technology and product research and development. It aims to develop implantable brain-computer interface medical devices that can achieve clinical applications such as motor function replacement, sensory repair, and neurological regulation. According to the shareholding structure, the controlling shareholders and actual controllers of the company are Zhao Zhengtuo and Li Xue, who together control 36.35% of the company's shares. In terms of financing, the company completed strategic financing of 500 million yuan in March 2026, led by Alibaba, SDIC Venture Capital, and continued follow-up by institutions such as Tencent, Source Code Capital, and Qiming Venture Capital; as of September 2026, the company's cumulative financing amount reached 2,600 billion yuan, and shareholders covered Alibaba, Tencent, Geely Capital, Ningde Era and many specialized medical funds and state-owned platforms.
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